Healthcare-acquired Infections

Clostridioides difficile infection is often confirmed through toxin testing, yet toxin tests alone may not be sufficient for diagnosing and guiding treatment decisions for patients with CDI.

“The presence of a toxigenic strain does not always equal disease,” said David Lyerly, PhD, during a session on C. difficile toxin testing at the Peggy Lillis Foundation 2022 National C. diff Advocacy Summit.

Dr. Lyerly, the chief science officer at Techlab, explained that exotoxins A and B are produced by specific strains of C. difficile and are involved in infections, but some patients who test positive for these toxins by polymerase chain reaction or other tests do not have CDI or they are not appropriate candidates for CDI treatment.

Several studies conducted during the past decade, however, support the importance of toxin detection. Some research has suggested that toxin-positive patients tend to have more clinically severe disease than those who test negative, he noted.

Although its use is limited when it is used alone, toxin testing is needed to confirm a CDI diagnosis and to ensure antibiotic stewardship, Dr. Lyerly said.

He suggested that, in addition to toxin testing, there is a need for molecular measures and other improved diagnostics to identify candidates most likely to benefit from CDI treatment.

“Because we generally detect toxin genes instead of toxin proteins, you can identify persons colonized with toxigenic C. difficile who do not actually have CDI,” Kevin W. Garey, PharmD, from the University of Houston, said in an interview.

Dr. Garey added that a person could likewise have low levels of toxins that aren’t detected by toxin tests but could still have CDI.

“Given this, better diagnostics that incorporate active toxin production and your body’s response to those toxins are needed,” he said, especially since C. difficile toxins are responsible for disease sequelae, including gastroenteritis, colonic perforation, sepsis, and death.
 

Toxin testing a ‘controversial area’

“C. difficile toxin testing has been a controversial area for almost a decade or more,” Shruti K. Gohil, MD, from University of California, Irvine, Health Epidemiology and Infection Prevention, said in an interview.

Dr. Gohil noted that toxin testing is a better test for clinical C. difficile colitis but by itself can miss C. difficile. “So, we are in this conundrum nationally,” she said.

“Many facilities will use a double- or triple-test strategy to make sure that you have a true C. difficile case mandating the use of antibiotics,” she explained. “The reason we test specifically with the enzyme immunoassay or toxin test is to know whether or not you have real C. difficile that’s actively producing the toxin for colitis.”

A patient with C. difficile who has been treated and is in recovery may still test positive on a C. difficile toxin test, added Dr. Gohil. “It would be great if we had a test that could really judge an active, clinical C. difficile infection. This [test] would help in identifying the right patients who need treatment and would also be able to tell if a patient has been cleared of C. difficile.”

Dr. Lyerly is an employee of Techlab. Dr. Garey and Dr. Gohil reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Clostridioides difficile infection is often confirmed through toxin testing, yet toxin tests alone may not be sufficient for diagnosing and guiding treatment decisions for patients with CDI.

“The presence of a toxigenic strain does not always equal disease,” said David Lyerly, PhD, during a session on C. difficile toxin testing at the Peggy Lillis Foundation 2022 National C. diff Advocacy Summit.

Dr. Lyerly, the chief science officer at Techlab, explained that exotoxins A and B are produced by specific strains of C. difficile and are involved in infections, but some patients who test positive for these toxins by polymerase chain reaction or other tests do not have CDI or they are not appropriate candidates for CDI treatment.

Several studies conducted during the past decade, however, support the importance of toxin detection. Some research has suggested that toxin-positive patients tend to have more clinically severe disease than those who test negative, he noted.

Although its use is limited when it is used alone, toxin testing is needed to confirm a CDI diagnosis and to ensure antibiotic stewardship, Dr. Lyerly said.

He suggested that, in addition to toxin testing, there is a need for molecular measures and other improved diagnostics to identify candidates most likely to benefit from CDI treatment.

“Because we generally detect toxin genes instead of toxin proteins, you can identify persons colonized with toxigenic C. difficile who do not actually have CDI,” Kevin W. Garey, PharmD, from the University of Houston, said in an interview.

Dr. Garey added that a person could likewise have low levels of toxins that aren’t detected by toxin tests but could still have CDI.

“Given this, better diagnostics that incorporate active toxin production and your body’s response to those toxins are needed,” he said, especially since C. difficile toxins are responsible for disease sequelae, including gastroenteritis, colonic perforation, sepsis, and death.
 

Toxin testing a ‘controversial area’

“C. difficile toxin testing has been a controversial area for almost a decade or more,” Shruti K. Gohil, MD, from University of California, Irvine, Health Epidemiology and Infection Prevention, said in an interview.

Dr. Gohil noted that toxin testing is a better test for clinical C. difficile colitis but by itself can miss C. difficile. “So, we are in this conundrum nationally,” she said.

“Many facilities will use a double- or triple-test strategy to make sure that you have a true C. difficile case mandating the use of antibiotics,” she explained. “The reason we test specifically with the enzyme immunoassay or toxin test is to know whether or not you have real C. difficile that’s actively producing the toxin for colitis.”

A patient with C. difficile who has been treated and is in recovery may still test positive on a C. difficile toxin test, added Dr. Gohil. “It would be great if we had a test that could really judge an active, clinical C. difficile infection. This [test] would help in identifying the right patients who need treatment and would also be able to tell if a patient has been cleared of C. difficile.”

Dr. Lyerly is an employee of Techlab. Dr. Garey and Dr. Gohil reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Clostridioides difficile infection is often confirmed through toxin testing, yet toxin tests alone may not be sufficient for diagnosing and guiding treatment decisions for patients with CDI.

“The presence of a toxigenic strain does not always equal disease,” said David Lyerly, PhD, during a session on C. difficile toxin testing at the Peggy Lillis Foundation 2022 National C. diff Advocacy Summit.

Dr. Lyerly, the chief science officer at Techlab, explained that exotoxins A and B are produced by specific strains of C. difficile and are involved in infections, but some patients who test positive for these toxins by polymerase chain reaction or other tests do not have CDI or they are not appropriate candidates for CDI treatment.

Several studies conducted during the past decade, however, support the importance of toxin detection. Some research has suggested that toxin-positive patients tend to have more clinically severe disease than those who test negative, he noted.

Although its use is limited when it is used alone, toxin testing is needed to confirm a CDI diagnosis and to ensure antibiotic stewardship, Dr. Lyerly said.

He suggested that, in addition to toxin testing, there is a need for molecular measures and other improved diagnostics to identify candidates most likely to benefit from CDI treatment.

“Because we generally detect toxin genes instead of toxin proteins, you can identify persons colonized with toxigenic C. difficile who do not actually have CDI,” Kevin W. Garey, PharmD, from the University of Houston, said in an interview.

Dr. Garey added that a person could likewise have low levels of toxins that aren’t detected by toxin tests but could still have CDI.

“Given this, better diagnostics that incorporate active toxin production and your body’s response to those toxins are needed,” he said, especially since C. difficile toxins are responsible for disease sequelae, including gastroenteritis, colonic perforation, sepsis, and death.
 

Toxin testing a ‘controversial area’

“C. difficile toxin testing has been a controversial area for almost a decade or more,” Shruti K. Gohil, MD, from University of California, Irvine, Health Epidemiology and Infection Prevention, said in an interview.

Dr. Gohil noted that toxin testing is a better test for clinical C. difficile colitis but by itself can miss C. difficile. “So, we are in this conundrum nationally,” she said.

“Many facilities will use a double- or triple-test strategy to make sure that you have a true C. difficile case mandating the use of antibiotics,” she explained. “The reason we test specifically with the enzyme immunoassay or toxin test is to know whether or not you have real C. difficile that’s actively producing the toxin for colitis.”

A patient with C. difficile who has been treated and is in recovery may still test positive on a C. difficile toxin test, added Dr. Gohil. “It would be great if we had a test that could really judge an active, clinical C. difficile infection. This [test] would help in identifying the right patients who need treatment and would also be able to tell if a patient has been cleared of C. difficile.”

Dr. Lyerly is an employee of Techlab. Dr. Garey and Dr. Gohil reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Hospitalized patients who are asymptomatic Clostridioides difficile carriers may infect people they live with after they return home, a study based on U.S. insurance claim data suggests.

Although C. difficile infection (CDI) is considered to be a common hospital-acquired infection, reports of community-associated CDI in patients who have not been hospitalized are increasing, the authors wrote in Emerging Infectious Diseases.

“Individuals in households where another family member was recently hospitalized but not diagnosed with a CDI appear to be at increased risk for CDI,” said lead author Aaron C. Miller, PhD, a research assistant professor in the department of internal medicine at the University of Iowa, Iowa City. “When individuals are hospitalized, they may become colonized with C. difficile without developing symptoms and subsequently transmit the pathogen to other family members after they return home,” he said by email.

Dr. Miller and colleagues analyzed insurance claims data from 2001 through 2017 using the U.S. Commercial Claims and Medicare Supplemental datasets of IBM MarketScan Research Databases. Over that period, they searched employer-sponsored commercial insurance claims and Medicare supplemental claims of 194,424 enrollees, and they linked claims from multiple family members in the same enrollment plan.

They identified 224,818 CDI cases, and 3,871 of them were considered potential asymptomatic C. difficile transmissions from a recently hospitalized family member.

The researchers gathered monthly C. difficile incidence data from households with a family member who had been hospitalized within the past 60 days and compared them with data from households without a hospitalized family member.

Enrollees exposed to a recently hospitalized family member had a 73% greater incidence of CDI compared with enrollees who were not exposed. The longer the family member’s hospital stay, the greater the risk that someone in the household became infected.

Compared with people whose family members were hospitalized less than 1 day, people whose family members were hospitalized from 1 to 3 days had an incidence rate ratio (IRR) of 1.30 (95% confidence interval [CI], 1.19-1.41), and those whose family members were hospitalized for more than 30 days had an IRR of 2.45 (95% CI, 1.66-3.60).

CDI incidence increased with age. Compared with people 17 years of age or younger, the IRR increased to 9.32 (95% CI, 8.92-9.73) for those over 65.

Females had higher CDI incidence than males (IRR 1.30; 95% CI, 1.28-1.33).

Households with an infant also had higher CDI incidence than those without (IRR 1.5; 95% CI, 1.44-1.58).

People taking antimicrobials had higher CDI IRRs: 2.69 (95% CI, 2.59-2.79) for low-CDI-risk antibiotics and 8.83 (95% CI, 8.63-9.03) for high-CDI-risk antibiotics.

People taking proton-pump inhibitors had an IRR of 2.23 (95% CI, 2.15-2.30).
 

Reactions from four experts

Douglas S. Paauw MD, MACP, professor of medicine and the chair for patient-centered clinical education at the University of Washington, Seattle, was not surprised by the findings. “We have wondered for a while how community-acquired CDI occurs,” he said in an email. “This important study offers a plausible explanation for some cases.”

Dr. Paauw advises doctors to consider CDI in their patients who have been exposed to hospitalized people.

David M. Aronoff, MD, FIDSA, FAAM, professor of medicine and the chair of the department of medicine at Indiana University, Indianapolis, advises providers to educate hospital patients being discharged about how CDI is spread and how they can practice good hand hygiene at home.

“An open question of this strong study is whether we should be testing certain hospital patients for asymptomatic C. difficile carriage before they are discharged,” he added in an email.

In a phone interview, Paul G. Auwaerter, MD, MBA, professor of medicine and clinical director of the division of infectious diseases at Johns Hopkins University, Baltimore, noted that community-acquired CDI is frequent enough that his institution performs routine C. difficile testing on all patients with unexplained severe diarrhea.

“This intriguing study bears additional research and follow-up because clearly these spores are hardy,” he said. “But a key point in this billings- and claims-based study is that no one knows where household members acquired CDI, whether it was actually through household transmission.”

Ramin Asgary, MD, MPH, FASTMH, associate professor of global health in the Milken Institute School of Public Health at George Washington University, Washington, cautioned about “an increasing issue with drug-resistant CDI.

“This important, timely study provides another step in the right direction to better understanding and addressing CDI and other hospital-based infections that have become increasing threats to the safety of our patients, their families, and health care in general,” he said in an email.

Dr. Miller said that the scale and scope of the data are strengths of the study, and he acknowledged that its basis in claims and billing data is a limitation. He and his group plan to explore genetic relationships involved in CDI transmission.

The study was funded by the Centers for Disease Control and Prevention. All authors and independent experts have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Hospitalized patients who are asymptomatic Clostridioides difficile carriers may infect people they live with after they return home, a study based on U.S. insurance claim data suggests.

Although C. difficile infection (CDI) is considered to be a common hospital-acquired infection, reports of community-associated CDI in patients who have not been hospitalized are increasing, the authors wrote in Emerging Infectious Diseases.

“Individuals in households where another family member was recently hospitalized but not diagnosed with a CDI appear to be at increased risk for CDI,” said lead author Aaron C. Miller, PhD, a research assistant professor in the department of internal medicine at the University of Iowa, Iowa City. “When individuals are hospitalized, they may become colonized with C. difficile without developing symptoms and subsequently transmit the pathogen to other family members after they return home,” he said by email.

Dr. Miller and colleagues analyzed insurance claims data from 2001 through 2017 using the U.S. Commercial Claims and Medicare Supplemental datasets of IBM MarketScan Research Databases. Over that period, they searched employer-sponsored commercial insurance claims and Medicare supplemental claims of 194,424 enrollees, and they linked claims from multiple family members in the same enrollment plan.

They identified 224,818 CDI cases, and 3,871 of them were considered potential asymptomatic C. difficile transmissions from a recently hospitalized family member.

The researchers gathered monthly C. difficile incidence data from households with a family member who had been hospitalized within the past 60 days and compared them with data from households without a hospitalized family member.

Enrollees exposed to a recently hospitalized family member had a 73% greater incidence of CDI compared with enrollees who were not exposed. The longer the family member’s hospital stay, the greater the risk that someone in the household became infected.

Compared with people whose family members were hospitalized less than 1 day, people whose family members were hospitalized from 1 to 3 days had an incidence rate ratio (IRR) of 1.30 (95% confidence interval [CI], 1.19-1.41), and those whose family members were hospitalized for more than 30 days had an IRR of 2.45 (95% CI, 1.66-3.60).

CDI incidence increased with age. Compared with people 17 years of age or younger, the IRR increased to 9.32 (95% CI, 8.92-9.73) for those over 65.

Females had higher CDI incidence than males (IRR 1.30; 95% CI, 1.28-1.33).

Households with an infant also had higher CDI incidence than those without (IRR 1.5; 95% CI, 1.44-1.58).

People taking antimicrobials had higher CDI IRRs: 2.69 (95% CI, 2.59-2.79) for low-CDI-risk antibiotics and 8.83 (95% CI, 8.63-9.03) for high-CDI-risk antibiotics.

People taking proton-pump inhibitors had an IRR of 2.23 (95% CI, 2.15-2.30).
 

Reactions from four experts

Douglas S. Paauw MD, MACP, professor of medicine and the chair for patient-centered clinical education at the University of Washington, Seattle, was not surprised by the findings. “We have wondered for a while how community-acquired CDI occurs,” he said in an email. “This important study offers a plausible explanation for some cases.”

Dr. Paauw advises doctors to consider CDI in their patients who have been exposed to hospitalized people.

David M. Aronoff, MD, FIDSA, FAAM, professor of medicine and the chair of the department of medicine at Indiana University, Indianapolis, advises providers to educate hospital patients being discharged about how CDI is spread and how they can practice good hand hygiene at home.

“An open question of this strong study is whether we should be testing certain hospital patients for asymptomatic C. difficile carriage before they are discharged,” he added in an email.

In a phone interview, Paul G. Auwaerter, MD, MBA, professor of medicine and clinical director of the division of infectious diseases at Johns Hopkins University, Baltimore, noted that community-acquired CDI is frequent enough that his institution performs routine C. difficile testing on all patients with unexplained severe diarrhea.

“This intriguing study bears additional research and follow-up because clearly these spores are hardy,” he said. “But a key point in this billings- and claims-based study is that no one knows where household members acquired CDI, whether it was actually through household transmission.”

Ramin Asgary, MD, MPH, FASTMH, associate professor of global health in the Milken Institute School of Public Health at George Washington University, Washington, cautioned about “an increasing issue with drug-resistant CDI.

“This important, timely study provides another step in the right direction to better understanding and addressing CDI and other hospital-based infections that have become increasing threats to the safety of our patients, their families, and health care in general,” he said in an email.

Dr. Miller said that the scale and scope of the data are strengths of the study, and he acknowledged that its basis in claims and billing data is a limitation. He and his group plan to explore genetic relationships involved in CDI transmission.

The study was funded by the Centers for Disease Control and Prevention. All authors and independent experts have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Hospitalized patients who are asymptomatic Clostridioides difficile carriers may infect people they live with after they return home, a study based on U.S. insurance claim data suggests.

Although C. difficile infection (CDI) is considered to be a common hospital-acquired infection, reports of community-associated CDI in patients who have not been hospitalized are increasing, the authors wrote in Emerging Infectious Diseases.

“Individuals in households where another family member was recently hospitalized but not diagnosed with a CDI appear to be at increased risk for CDI,” said lead author Aaron C. Miller, PhD, a research assistant professor in the department of internal medicine at the University of Iowa, Iowa City. “When individuals are hospitalized, they may become colonized with C. difficile without developing symptoms and subsequently transmit the pathogen to other family members after they return home,” he said by email.

Dr. Miller and colleagues analyzed insurance claims data from 2001 through 2017 using the U.S. Commercial Claims and Medicare Supplemental datasets of IBM MarketScan Research Databases. Over that period, they searched employer-sponsored commercial insurance claims and Medicare supplemental claims of 194,424 enrollees, and they linked claims from multiple family members in the same enrollment plan.

They identified 224,818 CDI cases, and 3,871 of them were considered potential asymptomatic C. difficile transmissions from a recently hospitalized family member.

The researchers gathered monthly C. difficile incidence data from households with a family member who had been hospitalized within the past 60 days and compared them with data from households without a hospitalized family member.

Enrollees exposed to a recently hospitalized family member had a 73% greater incidence of CDI compared with enrollees who were not exposed. The longer the family member’s hospital stay, the greater the risk that someone in the household became infected.

Compared with people whose family members were hospitalized less than 1 day, people whose family members were hospitalized from 1 to 3 days had an incidence rate ratio (IRR) of 1.30 (95% confidence interval [CI], 1.19-1.41), and those whose family members were hospitalized for more than 30 days had an IRR of 2.45 (95% CI, 1.66-3.60).

CDI incidence increased with age. Compared with people 17 years of age or younger, the IRR increased to 9.32 (95% CI, 8.92-9.73) for those over 65.

Females had higher CDI incidence than males (IRR 1.30; 95% CI, 1.28-1.33).

Households with an infant also had higher CDI incidence than those without (IRR 1.5; 95% CI, 1.44-1.58).

People taking antimicrobials had higher CDI IRRs: 2.69 (95% CI, 2.59-2.79) for low-CDI-risk antibiotics and 8.83 (95% CI, 8.63-9.03) for high-CDI-risk antibiotics.

People taking proton-pump inhibitors had an IRR of 2.23 (95% CI, 2.15-2.30).
 

Reactions from four experts

Douglas S. Paauw MD, MACP, professor of medicine and the chair for patient-centered clinical education at the University of Washington, Seattle, was not surprised by the findings. “We have wondered for a while how community-acquired CDI occurs,” he said in an email. “This important study offers a plausible explanation for some cases.”

Dr. Paauw advises doctors to consider CDI in their patients who have been exposed to hospitalized people.

David M. Aronoff, MD, FIDSA, FAAM, professor of medicine and the chair of the department of medicine at Indiana University, Indianapolis, advises providers to educate hospital patients being discharged about how CDI is spread and how they can practice good hand hygiene at home.

“An open question of this strong study is whether we should be testing certain hospital patients for asymptomatic C. difficile carriage before they are discharged,” he added in an email.

In a phone interview, Paul G. Auwaerter, MD, MBA, professor of medicine and clinical director of the division of infectious diseases at Johns Hopkins University, Baltimore, noted that community-acquired CDI is frequent enough that his institution performs routine C. difficile testing on all patients with unexplained severe diarrhea.

“This intriguing study bears additional research and follow-up because clearly these spores are hardy,” he said. “But a key point in this billings- and claims-based study is that no one knows where household members acquired CDI, whether it was actually through household transmission.”

Ramin Asgary, MD, MPH, FASTMH, associate professor of global health in the Milken Institute School of Public Health at George Washington University, Washington, cautioned about “an increasing issue with drug-resistant CDI.

“This important, timely study provides another step in the right direction to better understanding and addressing CDI and other hospital-based infections that have become increasing threats to the safety of our patients, their families, and health care in general,” he said in an email.

Dr. Miller said that the scale and scope of the data are strengths of the study, and he acknowledged that its basis in claims and billing data is a limitation. He and his group plan to explore genetic relationships involved in CDI transmission.

The study was funded by the Centers for Disease Control and Prevention. All authors and independent experts have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

About one in six patients with Creutzfeldt-Jakob disease (CJD) undergo surgery, raising the risk of iatrogenic transmission of this rare but universally fatal prion disease.

In a retrospective analysis, researchers found that 26 of 121 (21%) patients with probable or definite CJD at four U.S. academic medical centers underwent a total of 55 procedures.

These included high-risk procedures for two patients with neuropathologically proven CJD. One underwent ophthalmic artery aneurysm clipping for unruptured aneurysm, and the other underwent diagnostic brain biopsy.

“The findings were definitely surprising to me and my team – particularly the high frequency with which patients with an irreversible and particularly transmissible neurologic disease underwent invasive medical procedures either just before or shortly after the emergence of symptoms later attributed to CJD,” study investigator Gregory Day, MD, with the Mayo Clinic, Jacksonville, Fla., said in an interview.

The study was published online March 9, 2022, in JAMA Network Open.
 

Poor infection control

The investigators noted that the majority of CJD cases are sporadic or are inherited, but research shows that prion transmission can occur via contaminated tissues or reusable medical equipment.

While the risk of iatrogenic transmission is highest following procedures involving the central nervous system, where prion burden is highest, experimental models suggest CJD transmission can occur after contact with other tissues, including nasal mucosa, lung, lymph nodes, and spleen, the researchers noted.

“If these models are accurate, surgical procedures involving these tissues may pose a risk to patients,” the investigators wrote.

To determine the potential scope of this problem, the researchers examined the frequency of invasive procedures performed in patients with CJD at four tertiary care centers.

“In several cases, these procedures were done with clear indications [such as] fixation or joint replacement following a fracture. In several others, however, the procedures were unlikely to help the patient. For instance, a hip replacement for walking difficulties that were actually due to changes in the brain due to CJD,” Dr. Day said.

“Even more surprising was the low frequency with which appropriate surgical precautions/infection control procedures were used in patients with established diagnoses of CJD,” he noted.

Only one procedure was performed with sterilization techniques adequate to prevent CJD.

Dr. Day said the findings aren’t necessarily cause for immediate alarm, but they do highlight an area for potential improvement, including better screening of patients who have new and unexplained symptoms before proceeding with surgery, especially surgery of the central nervous system, where prion burden is high.

Another potential solution is to develop and support program surveillance and to work with public health organizations such the Centers for Disease Control and Prevention and the National Prion Disease Pathology Surveillance Center to elicit a surgical history in patients diagnosed with prion disease.

“Active nationwide surveillance is needed to determine the true scope of this potential problem and to develop strategies to mitigate the potential risk of iatrogenic prion transmission to future patients,” Dr. Day said.
 

True prevalence unknown

The authors of an invited commentary noted that, while most CJD infections occur sporadically, iatrogenic transmission is possible. Approximately 500 such cases have been reported worldwide to date.

“Yet, reported transmission from surgical procedures remains rare, with fewer than 10 confirmed CJD cases described in the literature, although the true prevalence is difficult to quantify as confirmed diagnosis requires autopsy,” wrote Beatrice Sun, MD, and Joseph Forrester, MD, with the department of surgery, Stanford (Calif.) University.

They noted that, over a 15-year period, 19 suspected iatrogenic CJD exposures were reported to the CDC – two from ophthalmology procedures, and 17 from neurosurgical procedures.

In all 19 cases, the diagnosis of CJD was unknown before the intervention, and all surgical instruments underwent normal decontamination protocols, which are inadequate to eradicate prion disease.

For patients with suspected or confirmed CJD, the World Health Organization has published infection control guidelines to prevent transmission of spongiform encephalopathies.

The guidelines recommend proper communication with all staff involved in the surgical procedure and the sterilization of supplies to be aware of potential exposure; minimizing the number of staff in the operating room; using single-use equipment whenever possible and disposing of it by incineration; using protective coverings for all nondisposable equipment; and scheduling such procedures at the end of the day to allow adequate time for decontamination.

Funding for the study was provided by the National Institutes of Health. Dr. Day owns stock in ANI Pharmaceuticals; serves as a consultant for Parabon Nanolabs, as a topic editor (dementia) for DynaMed, and as the clinical director of the Anti-NMDA Receptor Encephalitis Foundation (uncompensated). Dr. Forrester reported receiving unrestricted research funding from Varian and has received grant funding from the Surgical Infections Society.

A version of this article first appeared on Medscape.com.

About one in six patients with Creutzfeldt-Jakob disease (CJD) undergo surgery, raising the risk of iatrogenic transmission of this rare but universally fatal prion disease.

In a retrospective analysis, researchers found that 26 of 121 (21%) patients with probable or definite CJD at four U.S. academic medical centers underwent a total of 55 procedures.

These included high-risk procedures for two patients with neuropathologically proven CJD. One underwent ophthalmic artery aneurysm clipping for unruptured aneurysm, and the other underwent diagnostic brain biopsy.

“The findings were definitely surprising to me and my team – particularly the high frequency with which patients with an irreversible and particularly transmissible neurologic disease underwent invasive medical procedures either just before or shortly after the emergence of symptoms later attributed to CJD,” study investigator Gregory Day, MD, with the Mayo Clinic, Jacksonville, Fla., said in an interview.

The study was published online March 9, 2022, in JAMA Network Open.
 

Poor infection control

The investigators noted that the majority of CJD cases are sporadic or are inherited, but research shows that prion transmission can occur via contaminated tissues or reusable medical equipment.

While the risk of iatrogenic transmission is highest following procedures involving the central nervous system, where prion burden is highest, experimental models suggest CJD transmission can occur after contact with other tissues, including nasal mucosa, lung, lymph nodes, and spleen, the researchers noted.

“If these models are accurate, surgical procedures involving these tissues may pose a risk to patients,” the investigators wrote.

To determine the potential scope of this problem, the researchers examined the frequency of invasive procedures performed in patients with CJD at four tertiary care centers.

“In several cases, these procedures were done with clear indications [such as] fixation or joint replacement following a fracture. In several others, however, the procedures were unlikely to help the patient. For instance, a hip replacement for walking difficulties that were actually due to changes in the brain due to CJD,” Dr. Day said.

“Even more surprising was the low frequency with which appropriate surgical precautions/infection control procedures were used in patients with established diagnoses of CJD,” he noted.

Only one procedure was performed with sterilization techniques adequate to prevent CJD.

Dr. Day said the findings aren’t necessarily cause for immediate alarm, but they do highlight an area for potential improvement, including better screening of patients who have new and unexplained symptoms before proceeding with surgery, especially surgery of the central nervous system, where prion burden is high.

Another potential solution is to develop and support program surveillance and to work with public health organizations such the Centers for Disease Control and Prevention and the National Prion Disease Pathology Surveillance Center to elicit a surgical history in patients diagnosed with prion disease.

“Active nationwide surveillance is needed to determine the true scope of this potential problem and to develop strategies to mitigate the potential risk of iatrogenic prion transmission to future patients,” Dr. Day said.
 

True prevalence unknown

The authors of an invited commentary noted that, while most CJD infections occur sporadically, iatrogenic transmission is possible. Approximately 500 such cases have been reported worldwide to date.

“Yet, reported transmission from surgical procedures remains rare, with fewer than 10 confirmed CJD cases described in the literature, although the true prevalence is difficult to quantify as confirmed diagnosis requires autopsy,” wrote Beatrice Sun, MD, and Joseph Forrester, MD, with the department of surgery, Stanford (Calif.) University.

They noted that, over a 15-year period, 19 suspected iatrogenic CJD exposures were reported to the CDC – two from ophthalmology procedures, and 17 from neurosurgical procedures.

In all 19 cases, the diagnosis of CJD was unknown before the intervention, and all surgical instruments underwent normal decontamination protocols, which are inadequate to eradicate prion disease.

For patients with suspected or confirmed CJD, the World Health Organization has published infection control guidelines to prevent transmission of spongiform encephalopathies.

The guidelines recommend proper communication with all staff involved in the surgical procedure and the sterilization of supplies to be aware of potential exposure; minimizing the number of staff in the operating room; using single-use equipment whenever possible and disposing of it by incineration; using protective coverings for all nondisposable equipment; and scheduling such procedures at the end of the day to allow adequate time for decontamination.

Funding for the study was provided by the National Institutes of Health. Dr. Day owns stock in ANI Pharmaceuticals; serves as a consultant for Parabon Nanolabs, as a topic editor (dementia) for DynaMed, and as the clinical director of the Anti-NMDA Receptor Encephalitis Foundation (uncompensated). Dr. Forrester reported receiving unrestricted research funding from Varian and has received grant funding from the Surgical Infections Society.

A version of this article first appeared on Medscape.com.

About one in six patients with Creutzfeldt-Jakob disease (CJD) undergo surgery, raising the risk of iatrogenic transmission of this rare but universally fatal prion disease.

In a retrospective analysis, researchers found that 26 of 121 (21%) patients with probable or definite CJD at four U.S. academic medical centers underwent a total of 55 procedures.

These included high-risk procedures for two patients with neuropathologically proven CJD. One underwent ophthalmic artery aneurysm clipping for unruptured aneurysm, and the other underwent diagnostic brain biopsy.

“The findings were definitely surprising to me and my team – particularly the high frequency with which patients with an irreversible and particularly transmissible neurologic disease underwent invasive medical procedures either just before or shortly after the emergence of symptoms later attributed to CJD,” study investigator Gregory Day, MD, with the Mayo Clinic, Jacksonville, Fla., said in an interview.

The study was published online March 9, 2022, in JAMA Network Open.
 

Poor infection control

The investigators noted that the majority of CJD cases are sporadic or are inherited, but research shows that prion transmission can occur via contaminated tissues or reusable medical equipment.

While the risk of iatrogenic transmission is highest following procedures involving the central nervous system, where prion burden is highest, experimental models suggest CJD transmission can occur after contact with other tissues, including nasal mucosa, lung, lymph nodes, and spleen, the researchers noted.

“If these models are accurate, surgical procedures involving these tissues may pose a risk to patients,” the investigators wrote.

To determine the potential scope of this problem, the researchers examined the frequency of invasive procedures performed in patients with CJD at four tertiary care centers.

“In several cases, these procedures were done with clear indications [such as] fixation or joint replacement following a fracture. In several others, however, the procedures were unlikely to help the patient. For instance, a hip replacement for walking difficulties that were actually due to changes in the brain due to CJD,” Dr. Day said.

“Even more surprising was the low frequency with which appropriate surgical precautions/infection control procedures were used in patients with established diagnoses of CJD,” he noted.

Only one procedure was performed with sterilization techniques adequate to prevent CJD.

Dr. Day said the findings aren’t necessarily cause for immediate alarm, but they do highlight an area for potential improvement, including better screening of patients who have new and unexplained symptoms before proceeding with surgery, especially surgery of the central nervous system, where prion burden is high.

Another potential solution is to develop and support program surveillance and to work with public health organizations such the Centers for Disease Control and Prevention and the National Prion Disease Pathology Surveillance Center to elicit a surgical history in patients diagnosed with prion disease.

“Active nationwide surveillance is needed to determine the true scope of this potential problem and to develop strategies to mitigate the potential risk of iatrogenic prion transmission to future patients,” Dr. Day said.
 

True prevalence unknown

The authors of an invited commentary noted that, while most CJD infections occur sporadically, iatrogenic transmission is possible. Approximately 500 such cases have been reported worldwide to date.

“Yet, reported transmission from surgical procedures remains rare, with fewer than 10 confirmed CJD cases described in the literature, although the true prevalence is difficult to quantify as confirmed diagnosis requires autopsy,” wrote Beatrice Sun, MD, and Joseph Forrester, MD, with the department of surgery, Stanford (Calif.) University.

They noted that, over a 15-year period, 19 suspected iatrogenic CJD exposures were reported to the CDC – two from ophthalmology procedures, and 17 from neurosurgical procedures.

In all 19 cases, the diagnosis of CJD was unknown before the intervention, and all surgical instruments underwent normal decontamination protocols, which are inadequate to eradicate prion disease.

For patients with suspected or confirmed CJD, the World Health Organization has published infection control guidelines to prevent transmission of spongiform encephalopathies.

The guidelines recommend proper communication with all staff involved in the surgical procedure and the sterilization of supplies to be aware of potential exposure; minimizing the number of staff in the operating room; using single-use equipment whenever possible and disposing of it by incineration; using protective coverings for all nondisposable equipment; and scheduling such procedures at the end of the day to allow adequate time for decontamination.

Funding for the study was provided by the National Institutes of Health. Dr. Day owns stock in ANI Pharmaceuticals; serves as a consultant for Parabon Nanolabs, as a topic editor (dementia) for DynaMed, and as the clinical director of the Anti-NMDA Receptor Encephalitis Foundation (uncompensated). Dr. Forrester reported receiving unrestricted research funding from Varian and has received grant funding from the Surgical Infections Society.

A version of this article first appeared on Medscape.com.

Aerosolized hydrogen peroxide (aHP) can significantly reduce Clostridioides difficile infection (CDI) and is an effective disinfection system, suggests a study published in the American Journal of Infection Control.

C. difficile is the most common cause of health care–associated infection and increasingly occurs outside acute care hospitals. CDI symptoms can range from mild diarrhea to life-threatening colitis and sepsis, sometimes requiring urgent colon removal.

The Centers for Disease Control and Prevention has reported that, in the United States, 223,900 people required hospitalization for CDI and at least 12,800 died in 2017. Because of its large toll, CDI is grouped with antimicrobial-resistant “threat” organisms that often accompany it. People older than age 65 are at particular risk for disease, and at least 20% of patients experience recurrence.

In health care facilities, C. difficile is transmitted by bacterial spores that readily contaminate surfaces in patients’ rooms, from handrails to bedside tables to light switches and knobs. The spores are resistant to disinfectants, and rooms are often cleaned with bleach solutions. But those bleach fumes are irritating and may cause bronchospasm for patients with asthma or chronic obstructive pulmonary disease, and so alternative cleaning agents are needed.

In a retrospective study of an acute-care facility in Philadelphia, researchers compared the incidence of health care–associated CDI (HA-CDI) at the facility before and after adding aHP to other infection control practices. The aHP process produces an aerosolized dry-mist fog that contains a specified percentage of hydrogen peroxide. The fog is used after the room has been physically cleaned, settling on exposed surfaces and killing any remaining C. difficile spores.

The aHP mixture also contains 0.01% ionic silver. The study lead was Christopher L. Truitt, PhD, of Wayland Baptist University. Dr. Truitt told this news organization that hydrogen peroxide affects the endospore layer of the C. difficile organism and allows the “ionic silver to get into the cell and is shown to bind to enzymes and inactivate those inside the cell and actually improve the efficacy.”

Asked whether it’s the silver or the peroxide that disinfects, Dr. Truitt replied: “I can’t answer that. We don’t know if it’s the silver or the hydrogen peroxide. The commercially available chemical that’s used in that machine is a proprietary set-up ... with EPA approval as a sporicidal.”

In the baseline 27-month period, the hospital tallied 120 HA-CDI cases. After aHP was introduced, they counted just 72 cases over 33 months, a 41% decrease in the facility’s HA-CDI rate, from 4.6 per 10,000 patient-days to 2.7 per 10,000 patient-days (P < .001).

There was also a progressive decrease in hospital-onset CDI even after aHP was introduced, from 5.4 per 10,000 patient-days in 2015 to 1.4 per 10,000 patient-days in 2019.

Yoav Golan, MD, of Tufts University, Boston, told this news organization there were two major study limitations. “One is the fact that they did not control for other interventions that may have an effect on C. difficile: antibiotic stewardship and infection control,” he explained. This limitation was noted by the study authors and may explain the continued decline in infections after the introduction of aHP. The other limitation was not using a crossover study design.

“I would argue that they should have provided a little more information about their own practices in their own hospital when it comes to intensification of infection control [and] when it comes to a stewardship and changes that they’ve made to antibiotic usage,” Dr. Golan continued. “The description of changes over time and those practices would have allowed us to better understand the impact of the hydrogen peroxide intervention.”

Despite his criticisms, Dr. Golan concluded: “I think that the study is important. I think their intervention is unique in a way that they’ve been using an aerosolizing system that’s using a relatively high concentration of hydrogen peroxide. I think that there’s enough in this paper to suggest that using such a system may have an impact on the environment, and through that, on dissemination.”

Dr. Truitt added that a next step would be to compare aHP with ultraviolet light, which is commonly used to disinfect hospital rooms.

Dr. Truitt is chief science officer at Infection Controls, dba Germblast, a proprietary service that uses cold-mist hydrogen peroxide and other modalities to disinfect surfaces. Dr. Golan has reported being a consultant for Merck, Seres Therapeutics, Vedanta Biosciences, and Ferring Pharmaceuticals.

A version of this article first appeared on Medscape.com.

Aerosolized hydrogen peroxide (aHP) can significantly reduce Clostridioides difficile infection (CDI) and is an effective disinfection system, suggests a study published in the American Journal of Infection Control.

C. difficile is the most common cause of health care–associated infection and increasingly occurs outside acute care hospitals. CDI symptoms can range from mild diarrhea to life-threatening colitis and sepsis, sometimes requiring urgent colon removal.

The Centers for Disease Control and Prevention has reported that, in the United States, 223,900 people required hospitalization for CDI and at least 12,800 died in 2017. Because of its large toll, CDI is grouped with antimicrobial-resistant “threat” organisms that often accompany it. People older than age 65 are at particular risk for disease, and at least 20% of patients experience recurrence.

In health care facilities, C. difficile is transmitted by bacterial spores that readily contaminate surfaces in patients’ rooms, from handrails to bedside tables to light switches and knobs. The spores are resistant to disinfectants, and rooms are often cleaned with bleach solutions. But those bleach fumes are irritating and may cause bronchospasm for patients with asthma or chronic obstructive pulmonary disease, and so alternative cleaning agents are needed.

In a retrospective study of an acute-care facility in Philadelphia, researchers compared the incidence of health care–associated CDI (HA-CDI) at the facility before and after adding aHP to other infection control practices. The aHP process produces an aerosolized dry-mist fog that contains a specified percentage of hydrogen peroxide. The fog is used after the room has been physically cleaned, settling on exposed surfaces and killing any remaining C. difficile spores.

The aHP mixture also contains 0.01% ionic silver. The study lead was Christopher L. Truitt, PhD, of Wayland Baptist University. Dr. Truitt told this news organization that hydrogen peroxide affects the endospore layer of the C. difficile organism and allows the “ionic silver to get into the cell and is shown to bind to enzymes and inactivate those inside the cell and actually improve the efficacy.”

Asked whether it’s the silver or the peroxide that disinfects, Dr. Truitt replied: “I can’t answer that. We don’t know if it’s the silver or the hydrogen peroxide. The commercially available chemical that’s used in that machine is a proprietary set-up ... with EPA approval as a sporicidal.”

In the baseline 27-month period, the hospital tallied 120 HA-CDI cases. After aHP was introduced, they counted just 72 cases over 33 months, a 41% decrease in the facility’s HA-CDI rate, from 4.6 per 10,000 patient-days to 2.7 per 10,000 patient-days (P < .001).

There was also a progressive decrease in hospital-onset CDI even after aHP was introduced, from 5.4 per 10,000 patient-days in 2015 to 1.4 per 10,000 patient-days in 2019.

Yoav Golan, MD, of Tufts University, Boston, told this news organization there were two major study limitations. “One is the fact that they did not control for other interventions that may have an effect on C. difficile: antibiotic stewardship and infection control,” he explained. This limitation was noted by the study authors and may explain the continued decline in infections after the introduction of aHP. The other limitation was not using a crossover study design.

“I would argue that they should have provided a little more information about their own practices in their own hospital when it comes to intensification of infection control [and] when it comes to a stewardship and changes that they’ve made to antibiotic usage,” Dr. Golan continued. “The description of changes over time and those practices would have allowed us to better understand the impact of the hydrogen peroxide intervention.”

Despite his criticisms, Dr. Golan concluded: “I think that the study is important. I think their intervention is unique in a way that they’ve been using an aerosolizing system that’s using a relatively high concentration of hydrogen peroxide. I think that there’s enough in this paper to suggest that using such a system may have an impact on the environment, and through that, on dissemination.”

Dr. Truitt added that a next step would be to compare aHP with ultraviolet light, which is commonly used to disinfect hospital rooms.

Dr. Truitt is chief science officer at Infection Controls, dba Germblast, a proprietary service that uses cold-mist hydrogen peroxide and other modalities to disinfect surfaces. Dr. Golan has reported being a consultant for Merck, Seres Therapeutics, Vedanta Biosciences, and Ferring Pharmaceuticals.

A version of this article first appeared on Medscape.com.

Aerosolized hydrogen peroxide (aHP) can significantly reduce Clostridioides difficile infection (CDI) and is an effective disinfection system, suggests a study published in the American Journal of Infection Control.

C. difficile is the most common cause of health care–associated infection and increasingly occurs outside acute care hospitals. CDI symptoms can range from mild diarrhea to life-threatening colitis and sepsis, sometimes requiring urgent colon removal.

The Centers for Disease Control and Prevention has reported that, in the United States, 223,900 people required hospitalization for CDI and at least 12,800 died in 2017. Because of its large toll, CDI is grouped with antimicrobial-resistant “threat” organisms that often accompany it. People older than age 65 are at particular risk for disease, and at least 20% of patients experience recurrence.

In health care facilities, C. difficile is transmitted by bacterial spores that readily contaminate surfaces in patients’ rooms, from handrails to bedside tables to light switches and knobs. The spores are resistant to disinfectants, and rooms are often cleaned with bleach solutions. But those bleach fumes are irritating and may cause bronchospasm for patients with asthma or chronic obstructive pulmonary disease, and so alternative cleaning agents are needed.

In a retrospective study of an acute-care facility in Philadelphia, researchers compared the incidence of health care–associated CDI (HA-CDI) at the facility before and after adding aHP to other infection control practices. The aHP process produces an aerosolized dry-mist fog that contains a specified percentage of hydrogen peroxide. The fog is used after the room has been physically cleaned, settling on exposed surfaces and killing any remaining C. difficile spores.

The aHP mixture also contains 0.01% ionic silver. The study lead was Christopher L. Truitt, PhD, of Wayland Baptist University. Dr. Truitt told this news organization that hydrogen peroxide affects the endospore layer of the C. difficile organism and allows the “ionic silver to get into the cell and is shown to bind to enzymes and inactivate those inside the cell and actually improve the efficacy.”

Asked whether it’s the silver or the peroxide that disinfects, Dr. Truitt replied: “I can’t answer that. We don’t know if it’s the silver or the hydrogen peroxide. The commercially available chemical that’s used in that machine is a proprietary set-up ... with EPA approval as a sporicidal.”

In the baseline 27-month period, the hospital tallied 120 HA-CDI cases. After aHP was introduced, they counted just 72 cases over 33 months, a 41% decrease in the facility’s HA-CDI rate, from 4.6 per 10,000 patient-days to 2.7 per 10,000 patient-days (P < .001).

There was also a progressive decrease in hospital-onset CDI even after aHP was introduced, from 5.4 per 10,000 patient-days in 2015 to 1.4 per 10,000 patient-days in 2019.

Yoav Golan, MD, of Tufts University, Boston, told this news organization there were two major study limitations. “One is the fact that they did not control for other interventions that may have an effect on C. difficile: antibiotic stewardship and infection control,” he explained. This limitation was noted by the study authors and may explain the continued decline in infections after the introduction of aHP. The other limitation was not using a crossover study design.

“I would argue that they should have provided a little more information about their own practices in their own hospital when it comes to intensification of infection control [and] when it comes to a stewardship and changes that they’ve made to antibiotic usage,” Dr. Golan continued. “The description of changes over time and those practices would have allowed us to better understand the impact of the hydrogen peroxide intervention.”

Despite his criticisms, Dr. Golan concluded: “I think that the study is important. I think their intervention is unique in a way that they’ve been using an aerosolizing system that’s using a relatively high concentration of hydrogen peroxide. I think that there’s enough in this paper to suggest that using such a system may have an impact on the environment, and through that, on dissemination.”

Dr. Truitt added that a next step would be to compare aHP with ultraviolet light, which is commonly used to disinfect hospital rooms.

Dr. Truitt is chief science officer at Infection Controls, dba Germblast, a proprietary service that uses cold-mist hydrogen peroxide and other modalities to disinfect surfaces. Dr. Golan has reported being a consultant for Merck, Seres Therapeutics, Vedanta Biosciences, and Ferring Pharmaceuticals.

A version of this article first appeared on Medscape.com.

Vaginal cleansing showed no reduction in morbidity when performed before unscheduled cesarean deliveries, researchers reported at the 2022 Pregnancy Meeting of the Society for Maternal-Fetal Medicine.

Several studies have evaluated vaginal cleansing prior to cesarean delivery, with mixed results. The American College of Obstetricians and Gynecologists recommends clinicians consider cleansing prior to unscheduled cesareans, but that advice appears not to be widely heeded.

The new findings, from what the researchers called the single largest study of vaginal cleansing prior to cesarean delivery in the United States, showed no difference in post-cesarean infections when the vagina was cleansed with povidone-iodine prior to unscheduled cesarean delivery.

“These findings do not support routine vaginal cleansing prior to unscheduled cesarean deliveries,” lead author Lorene Atkins Temming, MD, medical director of labor and delivery at Atrium Health Wake Forest School of Medicine, Charlotte, North Carolina, told this news organization. The research was conducted at and sponsored by Washington University School of Medicine, St. Louis, where Dr. Temming did her fellowship.

Dr. Temming’s group compared vaginal cleansing with povidone-iodine in addition to routine abdominal cleansing to abdominal cleansing alone. Among the primary outcomes of the study was the effect of cleansing on post-cesarean infectious morbidity.

“There is a higher risk of infectious complications after cesarean delivery than other gynecologic surgeries,” Dr. Temming told this news organization. “While the reason for this isn’t entirely clear, it is thought to be because cesareans are often performed after a patient’s cervix is dilated. This dilation can allow normal bacteria that live in the vagina to ascend into the uterus and can increase the risk of infections.”

Patients undergoing cesarean delivery after labor were randomly assigned to undergo preoperative abdominal cleansing only (n = 304) or preoperative abdominal cleansing plus vaginal cleansing with povidone-iodine (n = 304). Women were included in the analysis if they underwent cesareans after regular contractions and any cervical dilation, if their membranes ruptured, or if they had the procedure performed when they were more than 4 cm dilated.

The primary outcome was composite infectious morbidity, a catchall that included surgical-site infection, maternal fever, endometritis, and wound complications within 30 days after cesarean delivery. The secondary outcomes were hospital readmission, visits to the emergency department, and treatment for neonatal sepsis.

The researchers observed no significant difference in the primary composite outcome between the two groups (11.7% vs. 11.7%, P = .98; 95% confidence interval, 0.6-1.5). “Vaginal cleansing appears to be unnecessary when preoperative antibiotics and skin antisepsis are performed,” Dr. Temming said.

Jennifer L. Lew, MD, an ob/gyn at Northwestern Medicine Kishwaukee Hospital in Dekalb, Illinois, said current practice regarding preparation for unscheduled cesarean surgery includes chlorhexidine on the abdomen and povidone-iodine for introducing a Foley catheter into the urethra.

“Many patients may already have a catheter in place due to labor and epidural, so they would not need” vaginal prep, Dr. Lew said. “Currently, the standard does not require doing a vaginal prep for any cesarean sections, those in labor or not.”

The researchers have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Vaginal cleansing showed no reduction in morbidity when performed before unscheduled cesarean deliveries, researchers reported at the 2022 Pregnancy Meeting of the Society for Maternal-Fetal Medicine.

Several studies have evaluated vaginal cleansing prior to cesarean delivery, with mixed results. The American College of Obstetricians and Gynecologists recommends clinicians consider cleansing prior to unscheduled cesareans, but that advice appears not to be widely heeded.

The new findings, from what the researchers called the single largest study of vaginal cleansing prior to cesarean delivery in the United States, showed no difference in post-cesarean infections when the vagina was cleansed with povidone-iodine prior to unscheduled cesarean delivery.

“These findings do not support routine vaginal cleansing prior to unscheduled cesarean deliveries,” lead author Lorene Atkins Temming, MD, medical director of labor and delivery at Atrium Health Wake Forest School of Medicine, Charlotte, North Carolina, told this news organization. The research was conducted at and sponsored by Washington University School of Medicine, St. Louis, where Dr. Temming did her fellowship.

Dr. Temming’s group compared vaginal cleansing with povidone-iodine in addition to routine abdominal cleansing to abdominal cleansing alone. Among the primary outcomes of the study was the effect of cleansing on post-cesarean infectious morbidity.

“There is a higher risk of infectious complications after cesarean delivery than other gynecologic surgeries,” Dr. Temming told this news organization. “While the reason for this isn’t entirely clear, it is thought to be because cesareans are often performed after a patient’s cervix is dilated. This dilation can allow normal bacteria that live in the vagina to ascend into the uterus and can increase the risk of infections.”

Patients undergoing cesarean delivery after labor were randomly assigned to undergo preoperative abdominal cleansing only (n = 304) or preoperative abdominal cleansing plus vaginal cleansing with povidone-iodine (n = 304). Women were included in the analysis if they underwent cesareans after regular contractions and any cervical dilation, if their membranes ruptured, or if they had the procedure performed when they were more than 4 cm dilated.

The primary outcome was composite infectious morbidity, a catchall that included surgical-site infection, maternal fever, endometritis, and wound complications within 30 days after cesarean delivery. The secondary outcomes were hospital readmission, visits to the emergency department, and treatment for neonatal sepsis.

The researchers observed no significant difference in the primary composite outcome between the two groups (11.7% vs. 11.7%, P = .98; 95% confidence interval, 0.6-1.5). “Vaginal cleansing appears to be unnecessary when preoperative antibiotics and skin antisepsis are performed,” Dr. Temming said.

Jennifer L. Lew, MD, an ob/gyn at Northwestern Medicine Kishwaukee Hospital in Dekalb, Illinois, said current practice regarding preparation for unscheduled cesarean surgery includes chlorhexidine on the abdomen and povidone-iodine for introducing a Foley catheter into the urethra.

“Many patients may already have a catheter in place due to labor and epidural, so they would not need” vaginal prep, Dr. Lew said. “Currently, the standard does not require doing a vaginal prep for any cesarean sections, those in labor or not.”

The researchers have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Vaginal cleansing showed no reduction in morbidity when performed before unscheduled cesarean deliveries, researchers reported at the 2022 Pregnancy Meeting of the Society for Maternal-Fetal Medicine.

Several studies have evaluated vaginal cleansing prior to cesarean delivery, with mixed results. The American College of Obstetricians and Gynecologists recommends clinicians consider cleansing prior to unscheduled cesareans, but that advice appears not to be widely heeded.

The new findings, from what the researchers called the single largest study of vaginal cleansing prior to cesarean delivery in the United States, showed no difference in post-cesarean infections when the vagina was cleansed with povidone-iodine prior to unscheduled cesarean delivery.

“These findings do not support routine vaginal cleansing prior to unscheduled cesarean deliveries,” lead author Lorene Atkins Temming, MD, medical director of labor and delivery at Atrium Health Wake Forest School of Medicine, Charlotte, North Carolina, told this news organization. The research was conducted at and sponsored by Washington University School of Medicine, St. Louis, where Dr. Temming did her fellowship.

Dr. Temming’s group compared vaginal cleansing with povidone-iodine in addition to routine abdominal cleansing to abdominal cleansing alone. Among the primary outcomes of the study was the effect of cleansing on post-cesarean infectious morbidity.

“There is a higher risk of infectious complications after cesarean delivery than other gynecologic surgeries,” Dr. Temming told this news organization. “While the reason for this isn’t entirely clear, it is thought to be because cesareans are often performed after a patient’s cervix is dilated. This dilation can allow normal bacteria that live in the vagina to ascend into the uterus and can increase the risk of infections.”

Patients undergoing cesarean delivery after labor were randomly assigned to undergo preoperative abdominal cleansing only (n = 304) or preoperative abdominal cleansing plus vaginal cleansing with povidone-iodine (n = 304). Women were included in the analysis if they underwent cesareans after regular contractions and any cervical dilation, if their membranes ruptured, or if they had the procedure performed when they were more than 4 cm dilated.

The primary outcome was composite infectious morbidity, a catchall that included surgical-site infection, maternal fever, endometritis, and wound complications within 30 days after cesarean delivery. The secondary outcomes were hospital readmission, visits to the emergency department, and treatment for neonatal sepsis.

The researchers observed no significant difference in the primary composite outcome between the two groups (11.7% vs. 11.7%, P = .98; 95% confidence interval, 0.6-1.5). “Vaginal cleansing appears to be unnecessary when preoperative antibiotics and skin antisepsis are performed,” Dr. Temming said.

Jennifer L. Lew, MD, an ob/gyn at Northwestern Medicine Kishwaukee Hospital in Dekalb, Illinois, said current practice regarding preparation for unscheduled cesarean surgery includes chlorhexidine on the abdomen and povidone-iodine for introducing a Foley catheter into the urethra.

“Many patients may already have a catheter in place due to labor and epidural, so they would not need” vaginal prep, Dr. Lew said. “Currently, the standard does not require doing a vaginal prep for any cesarean sections, those in labor or not.”

The researchers have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

More than HIV, more than malaria. The death toll worldwide from bacterial antimicrobial resistance (AMR) in 2019 exceeded 1.2 million people, according to a new study.

In terms of preventable deaths, 1.27 million people could have been saved if drug-resistant infections were replaced with infections susceptible to current antibiotics. Furthermore, 4.95 million fewer people would have died if drug-resistant infections were replaced by no infections, researchers estimated.

Although the COVID-19 pandemic took some focus off the AMR burden worldwide over the past 2 years, the urgency to address risk to public health did not ebb. In fact, based on the findings, the researchers noted that AMR is now a leading cause of death worldwide.

“If left unchecked, the spread of AMR could make many bacterial pathogens much more lethal in the future than they are today,” the researchers noted in the study, published online Jan. 20, 2022, in The Lancet.

“These findings are a warning signal that antibiotic resistance is placing pressure on health care systems and leading to significant health loss,” study author Kevin Ikuta, MD, MPH, told this news organization.

“We need to continue to adhere to and support infection prevention and control programs, be thoughtful about our antibiotic use, and advocate for increased funding to vaccine discovery and the antibiotic development pipeline,” added Dr. Ikuta, health sciences assistant clinical professor of medicine at the University of California, Los Angeles.

Although many investigators have studied AMR, this study is the largest in scope, covering 204 countries and territories and incorporating data on a comprehensive range of pathogens and pathogen-drug combinations.

Dr. Ikuta, lead author Christopher J.L. Murray, DPhil, and colleagues estimated the global burden of AMR using the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2019. They specifically looked at rates of death directly attributed to and separately those associated with resistance.
 

Regional differences

Broken down by 21 regions, Australasia had 6.5 deaths per 100,000 people attributable to AMR, the lowest rate reported. This region also had 28 deaths per 100,000 associated with AMR.

Researchers found the highest rates in western sub-Saharan Africa. Deaths attributable to AMR were 27.3 per 100,000 and associated death rate was 114.8 per 100,000.

Lower- and middle-income regions had the highest AMR death rates, although resistance remains a high-priority issue for high-income countries as well.

“It’s important to take a global perspective on resistant infections because we can learn about regions and countries that are experiencing the greatest burden, information that was previously unknown,” Dr. Ikuta said. “With these estimates policy makers can prioritize regions that are hotspots and would most benefit from additional interventions.”

Furthermore, the study emphasized the global nature of AMR. “We’ve seen over the last 2 years with COVID-19 that this sort of problem doesn’t respect country borders, and high rates of resistance in one location can spread across a region or spread globally pretty quickly,” Dr. Ikuta said.
 

Leading resistant infections

Lower respiratory and thorax infections, bloodstream infections, and intra-abdominal infections together accounted for almost 79% of such deaths linked to AMR.

The six leading pathogens are likely household names among infectious disease specialists. The researchers found Escherichia coli, Staphylococcus aureus, Klebsiella pneumoniae, Streptococcus pneumoniae, Acinetobacter baumannii, and Pseudomonas aeruginosa, each responsible for more than 250,000 AMR-associated deaths.

The study also revealed that resistance to several first-line antibiotic agents often used empirically to treat infections accounted for more than 70% of the AMR-attributable deaths. These included fluoroquinolones and beta-lactam antibiotics such as carbapenems, cephalosporins, and penicillins.

Courtesy The Lancet

Potential solutions offered

Dr. Murray and colleagues outlined five strategies to address the challenge of bacterial AMR:

• Infection prevention and control remain paramount in minimizing infections in general and AMR infections in particular.
• More vaccines are needed to reduce the need for antibiotics. “Vaccines are available for only one of the six leading pathogens (S. pneumoniae), although new vaccine programs are underway for S. aureus, E. coli, and others,” the researchers wrote.
• Reduce antibiotic use unrelated to treatment of human disease.
• Avoid using antibiotics for viral infections and other unnecessary indications.
• Invest in new antibiotic development and ensure access to second-line agents in areas without widespread access.

“Identifying strategies that can work to reduce the burden of bacterial AMR – either across a wide range of settings or those that are specifically tailored to the resources available and leading pathogen-drug combinations in a particular setting – is an urgent priority,” the researchers noted.
 

Admirable AMR research

The results of the study are “startling, but not surprising,” said Dr. Fowler, professor of medicine at Duke University, Durham, N.C.

The authors did a “nice job” of addressing both deaths attributable and associated with AMR, Dr. Fowler added. “Those two categories unlock applications, not just in terms of how you interpret it but also what you do about it.”

The deaths attributable to AMR show that there is more work to be done regarding infection control and prevention, Dr. Fowler said, including in areas of the world like lower- and middle-income countries where infection resistance is most pronounced.

The deaths associated with AMR can be more challenging to calculate – people with infections can die for multiple reasons. However, Dr. Fowler applauded the researchers for doing “as good a job as you can” in estimating the extent of associated mortality.
 

‘The overlooked pandemic of antimicrobial resistance’

In an accompanying editorial in The Lancet, Ramanan Laxminarayan, PhD, MPH, wrote: “As COVID-19 rages on, the pandemic of antimicrobial resistance continues in the shadows. The toll taken by AMR on patients and their families is largely invisible but is reflected in prolonged bacterial infections that extend hospital stays and cause needless deaths.”

Dr. Laxminarayan pointed out an irony with AMR in different regions. Some of the AMR burden in sub-Saharan Africa is “probably due to inadequate access to antibiotics and high infection levels, albeit at low levels of resistance, whereas in south Asia and Latin America, it is because of high resistance even with good access to antibiotics.”

More funding to address AMR is needed, Dr. Laxminarayan noted. “Even the lower end of 911,000 deaths estimated by Murray and colleagues is higher than the number of deaths from HIV, which attracts close to U.S. $50 billion each year. However, global spending on addressing AMR is probably much lower than that.” Dr. Laxminarayan is an economist and epidemiologist affiliated with the Center for Disease Dynamics, Economics & Policy in Washington, D.C., and the Global Antibiotic Research and Development Partnership in Geneva.
 

An overlap with COVID-19

The Lancet report is likely “to bring more attention to AMR, especially since so many people have been distracted by COVID, and rightly so,” Dr. Fowler predicted. “The world has had its hands full with COVID.”

The two infections interact in direct ways, Dr. Fowler added. For example, some people hospitalized for COVID-19 for an extended time could develop progressively drug-resistant bacteria – leading to a superinfection.

The overlap could be illustrated by a Venn diagram, he said. A yellow circle could illustrate people with COVID-19 who are asymptomatic or who remain outpatients. Next to that would be a blue circle showing people who develop AMR infections. Where the two circles overlap would be green for those hospitalized who – because of receiving steroids, being on a ventilator, or getting a central line – develop a superinfection.
 

Official guidance continues

The study comes in the context of recent guidance and federal action on AMR. For example, the Infectious Diseases Society of America released new guidelines for AMR in November 2021 as part of ongoing advice on prevention and treatment of this “ongoing crisis.”

This most recent IDSA guidance addresses three pathogens in particular: AmpC beta-lactamase–producing Enterobacterales, carbapenem-resistant A. baumannii, and Stenotrophomonas maltophilia.

Also in November, the World Health Organization released an updated fact sheet on antimicrobial resistance. The WHO declared AMR one of the world’s top 10 global public health threats. The agency emphasized that misuse and overuse of antimicrobials are the main drivers in the development of drug-resistant pathogens. The WHO also pointed out that lack of clean water and sanitation in many areas of the world contribute to spread of microbes, including those resistant to current treatment options.

In September 2021, the Biden administration acknowledged the threat of AMR with allocation of more than $2 billion of the American Rescue Plan money for prevention and treatment of these infections.

Asked if there are any reasons for hope or optimism at this point, Dr. Ikuta said: “Definitely. We know what needs to be done to combat the spread of resistance. COVID-19 has demonstrated the importance of global commitment to infection control measures, such as hand washing and surveillance, and rapid investments in treatments, which can all be applied to antimicrobial resistance.”

The Bill & Melinda Gates Foundation, the Wellcome Trust, and the U.K. Department of Health and Social Care using U.K. aid funding managed by the Fleming Fund and other organizations provided funding for the study. Dr. Ikuta and Dr. Laxminarayan have disclosed no relevant financial relationships. Dr. Fowler reported receiving grants or honoraria, as well as serving as a consultant, for numerous sources. He also reported a patent pending in sepsis diagnostics and serving as chair of the V710 Scientific Advisory Committee (Merck).

A version of this article first appeared on Medscape.com.

More than HIV, more than malaria. The death toll worldwide from bacterial antimicrobial resistance (AMR) in 2019 exceeded 1.2 million people, according to a new study.

In terms of preventable deaths, 1.27 million people could have been saved if drug-resistant infections were replaced with infections susceptible to current antibiotics. Furthermore, 4.95 million fewer people would have died if drug-resistant infections were replaced by no infections, researchers estimated.

Although the COVID-19 pandemic took some focus off the AMR burden worldwide over the past 2 years, the urgency to address risk to public health did not ebb. In fact, based on the findings, the researchers noted that AMR is now a leading cause of death worldwide.

“If left unchecked, the spread of AMR could make many bacterial pathogens much more lethal in the future than they are today,” the researchers noted in the study, published online Jan. 20, 2022, in The Lancet.

“These findings are a warning signal that antibiotic resistance is placing pressure on health care systems and leading to significant health loss,” study author Kevin Ikuta, MD, MPH, told this news organization.

“We need to continue to adhere to and support infection prevention and control programs, be thoughtful about our antibiotic use, and advocate for increased funding to vaccine discovery and the antibiotic development pipeline,” added Dr. Ikuta, health sciences assistant clinical professor of medicine at the University of California, Los Angeles.

Although many investigators have studied AMR, this study is the largest in scope, covering 204 countries and territories and incorporating data on a comprehensive range of pathogens and pathogen-drug combinations.

Dr. Ikuta, lead author Christopher J.L. Murray, DPhil, and colleagues estimated the global burden of AMR using the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2019. They specifically looked at rates of death directly attributed to and separately those associated with resistance.
 

Regional differences

Broken down by 21 regions, Australasia had 6.5 deaths per 100,000 people attributable to AMR, the lowest rate reported. This region also had 28 deaths per 100,000 associated with AMR.

Researchers found the highest rates in western sub-Saharan Africa. Deaths attributable to AMR were 27.3 per 100,000 and associated death rate was 114.8 per 100,000.

Lower- and middle-income regions had the highest AMR death rates, although resistance remains a high-priority issue for high-income countries as well.

“It’s important to take a global perspective on resistant infections because we can learn about regions and countries that are experiencing the greatest burden, information that was previously unknown,” Dr. Ikuta said. “With these estimates policy makers can prioritize regions that are hotspots and would most benefit from additional interventions.”

Furthermore, the study emphasized the global nature of AMR. “We’ve seen over the last 2 years with COVID-19 that this sort of problem doesn’t respect country borders, and high rates of resistance in one location can spread across a region or spread globally pretty quickly,” Dr. Ikuta said.
 

Leading resistant infections

Lower respiratory and thorax infections, bloodstream infections, and intra-abdominal infections together accounted for almost 79% of such deaths linked to AMR.

The six leading pathogens are likely household names among infectious disease specialists. The researchers found Escherichia coli, Staphylococcus aureus, Klebsiella pneumoniae, Streptococcus pneumoniae, Acinetobacter baumannii, and Pseudomonas aeruginosa, each responsible for more than 250,000 AMR-associated deaths.

The study also revealed that resistance to several first-line antibiotic agents often used empirically to treat infections accounted for more than 70% of the AMR-attributable deaths. These included fluoroquinolones and beta-lactam antibiotics such as carbapenems, cephalosporins, and penicillins.

Courtesy The Lancet

Potential solutions offered

Dr. Murray and colleagues outlined five strategies to address the challenge of bacterial AMR:

• Infection prevention and control remain paramount in minimizing infections in general and AMR infections in particular.
• More vaccines are needed to reduce the need for antibiotics. “Vaccines are available for only one of the six leading pathogens (S. pneumoniae), although new vaccine programs are underway for S. aureus, E. coli, and others,” the researchers wrote.
• Reduce antibiotic use unrelated to treatment of human disease.
• Avoid using antibiotics for viral infections and other unnecessary indications.
• Invest in new antibiotic development and ensure access to second-line agents in areas without widespread access.

“Identifying strategies that can work to reduce the burden of bacterial AMR – either across a wide range of settings or those that are specifically tailored to the resources available and leading pathogen-drug combinations in a particular setting – is an urgent priority,” the researchers noted.
 

Admirable AMR research

The results of the study are “startling, but not surprising,” said Dr. Fowler, professor of medicine at Duke University, Durham, N.C.

The authors did a “nice job” of addressing both deaths attributable and associated with AMR, Dr. Fowler added. “Those two categories unlock applications, not just in terms of how you interpret it but also what you do about it.”

The deaths attributable to AMR show that there is more work to be done regarding infection control and prevention, Dr. Fowler said, including in areas of the world like lower- and middle-income countries where infection resistance is most pronounced.

The deaths associated with AMR can be more challenging to calculate – people with infections can die for multiple reasons. However, Dr. Fowler applauded the researchers for doing “as good a job as you can” in estimating the extent of associated mortality.
 

‘The overlooked pandemic of antimicrobial resistance’

In an accompanying editorial in The Lancet, Ramanan Laxminarayan, PhD, MPH, wrote: “As COVID-19 rages on, the pandemic of antimicrobial resistance continues in the shadows. The toll taken by AMR on patients and their families is largely invisible but is reflected in prolonged bacterial infections that extend hospital stays and cause needless deaths.”

Dr. Laxminarayan pointed out an irony with AMR in different regions. Some of the AMR burden in sub-Saharan Africa is “probably due to inadequate access to antibiotics and high infection levels, albeit at low levels of resistance, whereas in south Asia and Latin America, it is because of high resistance even with good access to antibiotics.”

More funding to address AMR is needed, Dr. Laxminarayan noted. “Even the lower end of 911,000 deaths estimated by Murray and colleagues is higher than the number of deaths from HIV, which attracts close to U.S. $50 billion each year. However, global spending on addressing AMR is probably much lower than that.” Dr. Laxminarayan is an economist and epidemiologist affiliated with the Center for Disease Dynamics, Economics & Policy in Washington, D.C., and the Global Antibiotic Research and Development Partnership in Geneva.
 

An overlap with COVID-19

The Lancet report is likely “to bring more attention to AMR, especially since so many people have been distracted by COVID, and rightly so,” Dr. Fowler predicted. “The world has had its hands full with COVID.”

The two infections interact in direct ways, Dr. Fowler added. For example, some people hospitalized for COVID-19 for an extended time could develop progressively drug-resistant bacteria – leading to a superinfection.

The overlap could be illustrated by a Venn diagram, he said. A yellow circle could illustrate people with COVID-19 who are asymptomatic or who remain outpatients. Next to that would be a blue circle showing people who develop AMR infections. Where the two circles overlap would be green for those hospitalized who – because of receiving steroids, being on a ventilator, or getting a central line – develop a superinfection.
 

Official guidance continues

The study comes in the context of recent guidance and federal action on AMR. For example, the Infectious Diseases Society of America released new guidelines for AMR in November 2021 as part of ongoing advice on prevention and treatment of this “ongoing crisis.”

This most recent IDSA guidance addresses three pathogens in particular: AmpC beta-lactamase–producing Enterobacterales, carbapenem-resistant A. baumannii, and Stenotrophomonas maltophilia.

Also in November, the World Health Organization released an updated fact sheet on antimicrobial resistance. The WHO declared AMR one of the world’s top 10 global public health threats. The agency emphasized that misuse and overuse of antimicrobials are the main drivers in the development of drug-resistant pathogens. The WHO also pointed out that lack of clean water and sanitation in many areas of the world contribute to spread of microbes, including those resistant to current treatment options.

In September 2021, the Biden administration acknowledged the threat of AMR with allocation of more than $2 billion of the American Rescue Plan money for prevention and treatment of these infections.

Asked if there are any reasons for hope or optimism at this point, Dr. Ikuta said: “Definitely. We know what needs to be done to combat the spread of resistance. COVID-19 has demonstrated the importance of global commitment to infection control measures, such as hand washing and surveillance, and rapid investments in treatments, which can all be applied to antimicrobial resistance.”

The Bill & Melinda Gates Foundation, the Wellcome Trust, and the U.K. Department of Health and Social Care using U.K. aid funding managed by the Fleming Fund and other organizations provided funding for the study. Dr. Ikuta and Dr. Laxminarayan have disclosed no relevant financial relationships. Dr. Fowler reported receiving grants or honoraria, as well as serving as a consultant, for numerous sources. He also reported a patent pending in sepsis diagnostics and serving as chair of the V710 Scientific Advisory Committee (Merck).

A version of this article first appeared on Medscape.com.

More than HIV, more than malaria. The death toll worldwide from bacterial antimicrobial resistance (AMR) in 2019 exceeded 1.2 million people, according to a new study.

In terms of preventable deaths, 1.27 million people could have been saved if drug-resistant infections were replaced with infections susceptible to current antibiotics. Furthermore, 4.95 million fewer people would have died if drug-resistant infections were replaced by no infections, researchers estimated.

Although the COVID-19 pandemic took some focus off the AMR burden worldwide over the past 2 years, the urgency to address risk to public health did not ebb. In fact, based on the findings, the researchers noted that AMR is now a leading cause of death worldwide.

“If left unchecked, the spread of AMR could make many bacterial pathogens much more lethal in the future than they are today,” the researchers noted in the study, published online Jan. 20, 2022, in The Lancet.

“These findings are a warning signal that antibiotic resistance is placing pressure on health care systems and leading to significant health loss,” study author Kevin Ikuta, MD, MPH, told this news organization.

“We need to continue to adhere to and support infection prevention and control programs, be thoughtful about our antibiotic use, and advocate for increased funding to vaccine discovery and the antibiotic development pipeline,” added Dr. Ikuta, health sciences assistant clinical professor of medicine at the University of California, Los Angeles.

Although many investigators have studied AMR, this study is the largest in scope, covering 204 countries and territories and incorporating data on a comprehensive range of pathogens and pathogen-drug combinations.

Dr. Ikuta, lead author Christopher J.L. Murray, DPhil, and colleagues estimated the global burden of AMR using the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2019. They specifically looked at rates of death directly attributed to and separately those associated with resistance.
 

Regional differences

Broken down by 21 regions, Australasia had 6.5 deaths per 100,000 people attributable to AMR, the lowest rate reported. This region also had 28 deaths per 100,000 associated with AMR.

Researchers found the highest rates in western sub-Saharan Africa. Deaths attributable to AMR were 27.3 per 100,000 and associated death rate was 114.8 per 100,000.

Lower- and middle-income regions had the highest AMR death rates, although resistance remains a high-priority issue for high-income countries as well.

“It’s important to take a global perspective on resistant infections because we can learn about regions and countries that are experiencing the greatest burden, information that was previously unknown,” Dr. Ikuta said. “With these estimates policy makers can prioritize regions that are hotspots and would most benefit from additional interventions.”

Furthermore, the study emphasized the global nature of AMR. “We’ve seen over the last 2 years with COVID-19 that this sort of problem doesn’t respect country borders, and high rates of resistance in one location can spread across a region or spread globally pretty quickly,” Dr. Ikuta said.
 

Leading resistant infections

Lower respiratory and thorax infections, bloodstream infections, and intra-abdominal infections together accounted for almost 79% of such deaths linked to AMR.

The six leading pathogens are likely household names among infectious disease specialists. The researchers found Escherichia coli, Staphylococcus aureus, Klebsiella pneumoniae, Streptococcus pneumoniae, Acinetobacter baumannii, and Pseudomonas aeruginosa, each responsible for more than 250,000 AMR-associated deaths.

The study also revealed that resistance to several first-line antibiotic agents often used empirically to treat infections accounted for more than 70% of the AMR-attributable deaths. These included fluoroquinolones and beta-lactam antibiotics such as carbapenems, cephalosporins, and penicillins.

Courtesy The Lancet

Potential solutions offered

Dr. Murray and colleagues outlined five strategies to address the challenge of bacterial AMR:

• Infection prevention and control remain paramount in minimizing infections in general and AMR infections in particular.
• More vaccines are needed to reduce the need for antibiotics. “Vaccines are available for only one of the six leading pathogens (S. pneumoniae), although new vaccine programs are underway for S. aureus, E. coli, and others,” the researchers wrote.
• Reduce antibiotic use unrelated to treatment of human disease.
• Avoid using antibiotics for viral infections and other unnecessary indications.
• Invest in new antibiotic development and ensure access to second-line agents in areas without widespread access.

“Identifying strategies that can work to reduce the burden of bacterial AMR – either across a wide range of settings or those that are specifically tailored to the resources available and leading pathogen-drug combinations in a particular setting – is an urgent priority,” the researchers noted.
 

Admirable AMR research

The results of the study are “startling, but not surprising,” said Dr. Fowler, professor of medicine at Duke University, Durham, N.C.

The authors did a “nice job” of addressing both deaths attributable and associated with AMR, Dr. Fowler added. “Those two categories unlock applications, not just in terms of how you interpret it but also what you do about it.”

The deaths attributable to AMR show that there is more work to be done regarding infection control and prevention, Dr. Fowler said, including in areas of the world like lower- and middle-income countries where infection resistance is most pronounced.

The deaths associated with AMR can be more challenging to calculate – people with infections can die for multiple reasons. However, Dr. Fowler applauded the researchers for doing “as good a job as you can” in estimating the extent of associated mortality.
 

‘The overlooked pandemic of antimicrobial resistance’

In an accompanying editorial in The Lancet, Ramanan Laxminarayan, PhD, MPH, wrote: “As COVID-19 rages on, the pandemic of antimicrobial resistance continues in the shadows. The toll taken by AMR on patients and their families is largely invisible but is reflected in prolonged bacterial infections that extend hospital stays and cause needless deaths.”

Dr. Laxminarayan pointed out an irony with AMR in different regions. Some of the AMR burden in sub-Saharan Africa is “probably due to inadequate access to antibiotics and high infection levels, albeit at low levels of resistance, whereas in south Asia and Latin America, it is because of high resistance even with good access to antibiotics.”

More funding to address AMR is needed, Dr. Laxminarayan noted. “Even the lower end of 911,000 deaths estimated by Murray and colleagues is higher than the number of deaths from HIV, which attracts close to U.S. $50 billion each year. However, global spending on addressing AMR is probably much lower than that.” Dr. Laxminarayan is an economist and epidemiologist affiliated with the Center for Disease Dynamics, Economics & Policy in Washington, D.C., and the Global Antibiotic Research and Development Partnership in Geneva.
 

An overlap with COVID-19

The Lancet report is likely “to bring more attention to AMR, especially since so many people have been distracted by COVID, and rightly so,” Dr. Fowler predicted. “The world has had its hands full with COVID.”

The two infections interact in direct ways, Dr. Fowler added. For example, some people hospitalized for COVID-19 for an extended time could develop progressively drug-resistant bacteria – leading to a superinfection.

The overlap could be illustrated by a Venn diagram, he said. A yellow circle could illustrate people with COVID-19 who are asymptomatic or who remain outpatients. Next to that would be a blue circle showing people who develop AMR infections. Where the two circles overlap would be green for those hospitalized who – because of receiving steroids, being on a ventilator, or getting a central line – develop a superinfection.
 

Official guidance continues

The study comes in the context of recent guidance and federal action on AMR. For example, the Infectious Diseases Society of America released new guidelines for AMR in November 2021 as part of ongoing advice on prevention and treatment of this “ongoing crisis.”

This most recent IDSA guidance addresses three pathogens in particular: AmpC beta-lactamase–producing Enterobacterales, carbapenem-resistant A. baumannii, and Stenotrophomonas maltophilia.

Also in November, the World Health Organization released an updated fact sheet on antimicrobial resistance. The WHO declared AMR one of the world’s top 10 global public health threats. The agency emphasized that misuse and overuse of antimicrobials are the main drivers in the development of drug-resistant pathogens. The WHO also pointed out that lack of clean water and sanitation in many areas of the world contribute to spread of microbes, including those resistant to current treatment options.

In September 2021, the Biden administration acknowledged the threat of AMR with allocation of more than $2 billion of the American Rescue Plan money for prevention and treatment of these infections.

Asked if there are any reasons for hope or optimism at this point, Dr. Ikuta said: “Definitely. We know what needs to be done to combat the spread of resistance. COVID-19 has demonstrated the importance of global commitment to infection control measures, such as hand washing and surveillance, and rapid investments in treatments, which can all be applied to antimicrobial resistance.”

The Bill & Melinda Gates Foundation, the Wellcome Trust, and the U.K. Department of Health and Social Care using U.K. aid funding managed by the Fleming Fund and other organizations provided funding for the study. Dr. Ikuta and Dr. Laxminarayan have disclosed no relevant financial relationships. Dr. Fowler reported receiving grants or honoraria, as well as serving as a consultant, for numerous sources. He also reported a patent pending in sepsis diagnostics and serving as chair of the V710 Scientific Advisory Committee (Merck).

A version of this article first appeared on Medscape.com.

Although slightly fewer than 1% of hospitalizations for chronic obstructive pulmonary disease (COPD) are complicated by sepsis, this complication increases the risk for in-hospital mortality fivefold, investigators who studied a representative national sample found.

Among nearly 7 million hospitalizations in which the primary diagnosis was COPD, nearly 65,000 (0.93%) patients experienced sepsis as a complication. In all, 31% of patients with COPD and sepsis were discharged from the hospital to another care facility, and 19% of patients died in hospital, report Harshil Shah, MD, from Guthrie Corning (N.Y.) Hospital and colleagues.

“Our study highlights the need for better risk stratification in patients with COPD developing sepsis to improve the outcomes. Further studies are warranted to consider factoring some of the modifiable factors into account and to ameliorate the outcomes of sepsis during COPD hospitalizations,” Dr. Shah and colleagues write in a poster presented during the at the annual meeting of the American College of Chest Physicians, held virtually this year.

COPD has been associated with increased risk for sepsis because of the use of corticosteroids, underlying comorbidities, and, potentially, because of impaired barrier function, the authors note.
 

Nationwide sample

To determine the effects of sepsis and predictors of poor outcomes among patients hospitalized for COPD, the investigators used standard diagnostic codes to identify patients with a primary diagnosis of COPD from the Nationwide Inpatient Sample for the period 2007 through 2018 and sepsis from codes in secondary fields in the International Classification of Diseases (9th/10th Editions) Clinical Modification.

They identified a total of 6,940,615 hospitalizations in which the primary diagnosis was COPD; in 64,748 of those cases, sepsis was a complication.

As noted, the in-hospital death rate, one of two primary outcomes, was 19% for patients with COPD and sepsis, and the rate of discharge to other facilities was 31%.

In analysis adjusted for confounding factors, sepsis was associated with an odds ratio for mortality of 4.9 (P < .01) and an OR for discharge to a facility of 2.2 (P < .01).

With regard to trends, the investigators saw that, although the adjusted odds for in-hospital mortality remained stable over time, discharge to facilities increased significantly. In 2007, the adjusted OR was 2.2, whereas in 2018, it was 2.6 (P for trend = .02).

Predictors of in-hospital mortality among patients with sepsis included increasing age (OR, not shown), White ethnicity (OR, 1.2), treatment in the Northeast region (OR, 1.4), disseminated intravascular coagulation (OR, 3.7), pneumococcal infection (OR, 1.2), congestive heart failure (OR, 1.2), and renal failure (OR, 1.4; P < .01 for all comparisons).
 

Mortality risk for many patients

A COPD specialist who was not involved in the study told this news organization that sepsis is an uncommon but serious complication, not just for patients with COPD but also for those with other severe illnesses.

“Sepsis has a high risk for mortality whether a person has COPD or not,” commented David M. Mannino III MD, FCCP, FERS, professor of medicine at the University of Kentucky, Lexington, and a cofounder and co–medical director of the COPD Foundation.

“It’s not surprising that sepsis is lethal in this population; the question is, if you have COPD, are you more likely to have sepsis? And I think the answer is probably yes. The connection there is that people with COPD have a higher risk for pneumonia, and pneumonia itself is probably one of the biggest risk factors, or certainly an important risk factor, for the development of sepsis,” he said in an interview.

It would be interesting to see the relationship between sepsis and in-hospital mortality for patients with other chronic diseases or people without COPD, he said, and he would have liked to have seen more detailed information about trends over time than Dr. Shah and colleagues provided.

No funding source for the study was reported. Dr. Shah and colleagues and Dr. Mannino have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Although slightly fewer than 1% of hospitalizations for chronic obstructive pulmonary disease (COPD) are complicated by sepsis, this complication increases the risk for in-hospital mortality fivefold, investigators who studied a representative national sample found.

Among nearly 7 million hospitalizations in which the primary diagnosis was COPD, nearly 65,000 (0.93%) patients experienced sepsis as a complication. In all, 31% of patients with COPD and sepsis were discharged from the hospital to another care facility, and 19% of patients died in hospital, report Harshil Shah, MD, from Guthrie Corning (N.Y.) Hospital and colleagues.

“Our study highlights the need for better risk stratification in patients with COPD developing sepsis to improve the outcomes. Further studies are warranted to consider factoring some of the modifiable factors into account and to ameliorate the outcomes of sepsis during COPD hospitalizations,” Dr. Shah and colleagues write in a poster presented during the at the annual meeting of the American College of Chest Physicians, held virtually this year.

COPD has been associated with increased risk for sepsis because of the use of corticosteroids, underlying comorbidities, and, potentially, because of impaired barrier function, the authors note.
 

Nationwide sample

To determine the effects of sepsis and predictors of poor outcomes among patients hospitalized for COPD, the investigators used standard diagnostic codes to identify patients with a primary diagnosis of COPD from the Nationwide Inpatient Sample for the period 2007 through 2018 and sepsis from codes in secondary fields in the International Classification of Diseases (9th/10th Editions) Clinical Modification.

They identified a total of 6,940,615 hospitalizations in which the primary diagnosis was COPD; in 64,748 of those cases, sepsis was a complication.

As noted, the in-hospital death rate, one of two primary outcomes, was 19% for patients with COPD and sepsis, and the rate of discharge to other facilities was 31%.

In analysis adjusted for confounding factors, sepsis was associated with an odds ratio for mortality of 4.9 (P < .01) and an OR for discharge to a facility of 2.2 (P < .01).

With regard to trends, the investigators saw that, although the adjusted odds for in-hospital mortality remained stable over time, discharge to facilities increased significantly. In 2007, the adjusted OR was 2.2, whereas in 2018, it was 2.6 (P for trend = .02).

Predictors of in-hospital mortality among patients with sepsis included increasing age (OR, not shown), White ethnicity (OR, 1.2), treatment in the Northeast region (OR, 1.4), disseminated intravascular coagulation (OR, 3.7), pneumococcal infection (OR, 1.2), congestive heart failure (OR, 1.2), and renal failure (OR, 1.4; P < .01 for all comparisons).
 

Mortality risk for many patients

A COPD specialist who was not involved in the study told this news organization that sepsis is an uncommon but serious complication, not just for patients with COPD but also for those with other severe illnesses.

“Sepsis has a high risk for mortality whether a person has COPD or not,” commented David M. Mannino III MD, FCCP, FERS, professor of medicine at the University of Kentucky, Lexington, and a cofounder and co–medical director of the COPD Foundation.

“It’s not surprising that sepsis is lethal in this population; the question is, if you have COPD, are you more likely to have sepsis? And I think the answer is probably yes. The connection there is that people with COPD have a higher risk for pneumonia, and pneumonia itself is probably one of the biggest risk factors, or certainly an important risk factor, for the development of sepsis,” he said in an interview.

It would be interesting to see the relationship between sepsis and in-hospital mortality for patients with other chronic diseases or people without COPD, he said, and he would have liked to have seen more detailed information about trends over time than Dr. Shah and colleagues provided.

No funding source for the study was reported. Dr. Shah and colleagues and Dr. Mannino have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Although slightly fewer than 1% of hospitalizations for chronic obstructive pulmonary disease (COPD) are complicated by sepsis, this complication increases the risk for in-hospital mortality fivefold, investigators who studied a representative national sample found.

Among nearly 7 million hospitalizations in which the primary diagnosis was COPD, nearly 65,000 (0.93%) patients experienced sepsis as a complication. In all, 31% of patients with COPD and sepsis were discharged from the hospital to another care facility, and 19% of patients died in hospital, report Harshil Shah, MD, from Guthrie Corning (N.Y.) Hospital and colleagues.

“Our study highlights the need for better risk stratification in patients with COPD developing sepsis to improve the outcomes. Further studies are warranted to consider factoring some of the modifiable factors into account and to ameliorate the outcomes of sepsis during COPD hospitalizations,” Dr. Shah and colleagues write in a poster presented during the at the annual meeting of the American College of Chest Physicians, held virtually this year.

COPD has been associated with increased risk for sepsis because of the use of corticosteroids, underlying comorbidities, and, potentially, because of impaired barrier function, the authors note.
 

Nationwide sample

To determine the effects of sepsis and predictors of poor outcomes among patients hospitalized for COPD, the investigators used standard diagnostic codes to identify patients with a primary diagnosis of COPD from the Nationwide Inpatient Sample for the period 2007 through 2018 and sepsis from codes in secondary fields in the International Classification of Diseases (9th/10th Editions) Clinical Modification.

They identified a total of 6,940,615 hospitalizations in which the primary diagnosis was COPD; in 64,748 of those cases, sepsis was a complication.

As noted, the in-hospital death rate, one of two primary outcomes, was 19% for patients with COPD and sepsis, and the rate of discharge to other facilities was 31%.

In analysis adjusted for confounding factors, sepsis was associated with an odds ratio for mortality of 4.9 (P < .01) and an OR for discharge to a facility of 2.2 (P < .01).

With regard to trends, the investigators saw that, although the adjusted odds for in-hospital mortality remained stable over time, discharge to facilities increased significantly. In 2007, the adjusted OR was 2.2, whereas in 2018, it was 2.6 (P for trend = .02).

Predictors of in-hospital mortality among patients with sepsis included increasing age (OR, not shown), White ethnicity (OR, 1.2), treatment in the Northeast region (OR, 1.4), disseminated intravascular coagulation (OR, 3.7), pneumococcal infection (OR, 1.2), congestive heart failure (OR, 1.2), and renal failure (OR, 1.4; P < .01 for all comparisons).
 

Mortality risk for many patients

A COPD specialist who was not involved in the study told this news organization that sepsis is an uncommon but serious complication, not just for patients with COPD but also for those with other severe illnesses.

“Sepsis has a high risk for mortality whether a person has COPD or not,” commented David M. Mannino III MD, FCCP, FERS, professor of medicine at the University of Kentucky, Lexington, and a cofounder and co–medical director of the COPD Foundation.

“It’s not surprising that sepsis is lethal in this population; the question is, if you have COPD, are you more likely to have sepsis? And I think the answer is probably yes. The connection there is that people with COPD have a higher risk for pneumonia, and pneumonia itself is probably one of the biggest risk factors, or certainly an important risk factor, for the development of sepsis,” he said in an interview.

It would be interesting to see the relationship between sepsis and in-hospital mortality for patients with other chronic diseases or people without COPD, he said, and he would have liked to have seen more detailed information about trends over time than Dr. Shah and colleagues provided.

No funding source for the study was reported. Dr. Shah and colleagues and Dr. Mannino have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A new study from Orange County, California, shows how Candida auris, an emerging pathogen, was successfully identified and contained in long-term acute care hospitals (LTACHs) and ventilator-capable skilled-nursing facilities (vSNFs).

Lead author Ellora Karmarkar, MD, MSc, formerly an epidemic intelligence service officer with the Centers for Disease Control and Prevention and currently with the California Department of Public Health, said in an interview that the prospective surveillance of urine cultures for C. auris was prompted by “seeing what was happening in New York, New Jersey, and Illinois [being] pretty alarming for a lot of the health officials in California, [who] know that LTACHs are high-risk facilities because they take care of really sick people. Some of those people are there for a very long time.”

Therefore, the study authors decided to focus their investigations there, rather than in acute care hospitals, which were believed to be at lower risk for C. auris outbreaks.

The Orange County Health Department, working with the California Department of Health and the CDC, asked labs to prospectively identify all Candida isolates in urines from LTACHs between September 2018 and February 2019. Normally, labs do not speciate Candida from nonsterile body sites.

Dan Diekema, MD, an epidemiologist and clinical microbiologist at the University of Iowa, Iowa City, who was not involved in the study, told this news organization, “Acute care hospitals really ought to be moving toward doing species identification of Candida from nonsterile sites if they really want to have a better chance of detecting this early.”

The OCHD also screened LTACH and vSNF patients with composite cultures from the axilla-groin or nasal swabs. Screening was undertaken because 5%-10% of colonized patients later develop invasive infections, and 30%-60% die.

The first bloodstream infection was detected in May 2019. Per the report, published online Sept. 7 in Annals of Internal Medicine, “As of 1 January 2020, of 182 patients, 22 (12%) died within 30 days of C. auris identification; 47 (26%) died within 90 days. One of 47 deaths was attributed to C. auris.” Whole-genome sequencing showed that the isolates were all closely related in clade III.

Experts conducted extensive education in infection control at the LTACHs, and communication among the LTACHs and between the long-term facilities and acute care hospitals was improved. As a result, receiving facilities accepting transfers began culturing their newly admitted patients and quickly identified 4 of 99 patients with C. auris who had no known history of colonization. By October 2019, the outbreak was contained in two facilities, down from the nine where C. auris was initially found.

Dr. Diekema noted, “The challenge, of course, for a new emerging MDRO [multidrug-resistant organism] like Candida auris, is that the initial approach, in general, has to be almost passive, when you have not seen the organism. ... Passive surveillance means that you just carefully monitor your clinical cultures, and the first time you detect the MDRO of concern, then you begin doing the point prevalence surveys. ... This [prospective] kind of approach is really good for how we should move forward with both initial detection and containment of MDRO spread.”

Many outbreak studies are confined to a particular institution. Authors of an accompanying editorial commented that this study “underlines the importance of proactive protocols for outbreak investigations and containment measures across the entirety of the health care network serving at-risk patients.”

In her research, Dr. Karmarkar observed that, “some of these facilities don’t have the same infrastructure and infection prevention and control that an acute care hospital might.”

She said in an interview that, “one of the challenges was that people were so focused on COVID that they forgot about the MDROs. ... Some of the things that we recommend to help control Candida auris are also excellent practices for every other organism including COVID care. ... What I appreciated about this investigation is that every facility that we went to was so open to learning, so happy to have us there. They’re very interested in learning about Candida auris and understanding what they could do to control it.”

While recent attention has been on the frightening levels of multidrug resistance in C. auris, Dr. Karmarkar concluded that the “central message in our investigation is that with the right effort, the right approach, and the right team this is an intervenable issue. It’s not inevitable if the attention is focused on it to pick it up early and then try to contain it.”

Dr. Karmarkar reports no relevant financial relationships. Dr. Diekema reports research funding from bioMerieux and consulting fees from Opgen.

A version of this article first appeared on Medscape.com.

A new study from Orange County, California, shows how Candida auris, an emerging pathogen, was successfully identified and contained in long-term acute care hospitals (LTACHs) and ventilator-capable skilled-nursing facilities (vSNFs).

Lead author Ellora Karmarkar, MD, MSc, formerly an epidemic intelligence service officer with the Centers for Disease Control and Prevention and currently with the California Department of Public Health, said in an interview that the prospective surveillance of urine cultures for C. auris was prompted by “seeing what was happening in New York, New Jersey, and Illinois [being] pretty alarming for a lot of the health officials in California, [who] know that LTACHs are high-risk facilities because they take care of really sick people. Some of those people are there for a very long time.”

Therefore, the study authors decided to focus their investigations there, rather than in acute care hospitals, which were believed to be at lower risk for C. auris outbreaks.

The Orange County Health Department, working with the California Department of Health and the CDC, asked labs to prospectively identify all Candida isolates in urines from LTACHs between September 2018 and February 2019. Normally, labs do not speciate Candida from nonsterile body sites.

Dan Diekema, MD, an epidemiologist and clinical microbiologist at the University of Iowa, Iowa City, who was not involved in the study, told this news organization, “Acute care hospitals really ought to be moving toward doing species identification of Candida from nonsterile sites if they really want to have a better chance of detecting this early.”

The OCHD also screened LTACH and vSNF patients with composite cultures from the axilla-groin or nasal swabs. Screening was undertaken because 5%-10% of colonized patients later develop invasive infections, and 30%-60% die.

The first bloodstream infection was detected in May 2019. Per the report, published online Sept. 7 in Annals of Internal Medicine, “As of 1 January 2020, of 182 patients, 22 (12%) died within 30 days of C. auris identification; 47 (26%) died within 90 days. One of 47 deaths was attributed to C. auris.” Whole-genome sequencing showed that the isolates were all closely related in clade III.

Experts conducted extensive education in infection control at the LTACHs, and communication among the LTACHs and between the long-term facilities and acute care hospitals was improved. As a result, receiving facilities accepting transfers began culturing their newly admitted patients and quickly identified 4 of 99 patients with C. auris who had no known history of colonization. By October 2019, the outbreak was contained in two facilities, down from the nine where C. auris was initially found.

Dr. Diekema noted, “The challenge, of course, for a new emerging MDRO [multidrug-resistant organism] like Candida auris, is that the initial approach, in general, has to be almost passive, when you have not seen the organism. ... Passive surveillance means that you just carefully monitor your clinical cultures, and the first time you detect the MDRO of concern, then you begin doing the point prevalence surveys. ... This [prospective] kind of approach is really good for how we should move forward with both initial detection and containment of MDRO spread.”

Many outbreak studies are confined to a particular institution. Authors of an accompanying editorial commented that this study “underlines the importance of proactive protocols for outbreak investigations and containment measures across the entirety of the health care network serving at-risk patients.”

In her research, Dr. Karmarkar observed that, “some of these facilities don’t have the same infrastructure and infection prevention and control that an acute care hospital might.”

She said in an interview that, “one of the challenges was that people were so focused on COVID that they forgot about the MDROs. ... Some of the things that we recommend to help control Candida auris are also excellent practices for every other organism including COVID care. ... What I appreciated about this investigation is that every facility that we went to was so open to learning, so happy to have us there. They’re very interested in learning about Candida auris and understanding what they could do to control it.”

While recent attention has been on the frightening levels of multidrug resistance in C. auris, Dr. Karmarkar concluded that the “central message in our investigation is that with the right effort, the right approach, and the right team this is an intervenable issue. It’s not inevitable if the attention is focused on it to pick it up early and then try to contain it.”

Dr. Karmarkar reports no relevant financial relationships. Dr. Diekema reports research funding from bioMerieux and consulting fees from Opgen.

A version of this article first appeared on Medscape.com.

A new study from Orange County, California, shows how Candida auris, an emerging pathogen, was successfully identified and contained in long-term acute care hospitals (LTACHs) and ventilator-capable skilled-nursing facilities (vSNFs).

Lead author Ellora Karmarkar, MD, MSc, formerly an epidemic intelligence service officer with the Centers for Disease Control and Prevention and currently with the California Department of Public Health, said in an interview that the prospective surveillance of urine cultures for C. auris was prompted by “seeing what was happening in New York, New Jersey, and Illinois [being] pretty alarming for a lot of the health officials in California, [who] know that LTACHs are high-risk facilities because they take care of really sick people. Some of those people are there for a very long time.”

Therefore, the study authors decided to focus their investigations there, rather than in acute care hospitals, which were believed to be at lower risk for C. auris outbreaks.

The Orange County Health Department, working with the California Department of Health and the CDC, asked labs to prospectively identify all Candida isolates in urines from LTACHs between September 2018 and February 2019. Normally, labs do not speciate Candida from nonsterile body sites.

Dan Diekema, MD, an epidemiologist and clinical microbiologist at the University of Iowa, Iowa City, who was not involved in the study, told this news organization, “Acute care hospitals really ought to be moving toward doing species identification of Candida from nonsterile sites if they really want to have a better chance of detecting this early.”

The OCHD also screened LTACH and vSNF patients with composite cultures from the axilla-groin or nasal swabs. Screening was undertaken because 5%-10% of colonized patients later develop invasive infections, and 30%-60% die.

The first bloodstream infection was detected in May 2019. Per the report, published online Sept. 7 in Annals of Internal Medicine, “As of 1 January 2020, of 182 patients, 22 (12%) died within 30 days of C. auris identification; 47 (26%) died within 90 days. One of 47 deaths was attributed to C. auris.” Whole-genome sequencing showed that the isolates were all closely related in clade III.

Experts conducted extensive education in infection control at the LTACHs, and communication among the LTACHs and between the long-term facilities and acute care hospitals was improved. As a result, receiving facilities accepting transfers began culturing their newly admitted patients and quickly identified 4 of 99 patients with C. auris who had no known history of colonization. By October 2019, the outbreak was contained in two facilities, down from the nine where C. auris was initially found.

Dr. Diekema noted, “The challenge, of course, for a new emerging MDRO [multidrug-resistant organism] like Candida auris, is that the initial approach, in general, has to be almost passive, when you have not seen the organism. ... Passive surveillance means that you just carefully monitor your clinical cultures, and the first time you detect the MDRO of concern, then you begin doing the point prevalence surveys. ... This [prospective] kind of approach is really good for how we should move forward with both initial detection and containment of MDRO spread.”

Many outbreak studies are confined to a particular institution. Authors of an accompanying editorial commented that this study “underlines the importance of proactive protocols for outbreak investigations and containment measures across the entirety of the health care network serving at-risk patients.”

In her research, Dr. Karmarkar observed that, “some of these facilities don’t have the same infrastructure and infection prevention and control that an acute care hospital might.”

She said in an interview that, “one of the challenges was that people were so focused on COVID that they forgot about the MDROs. ... Some of the things that we recommend to help control Candida auris are also excellent practices for every other organism including COVID care. ... What I appreciated about this investigation is that every facility that we went to was so open to learning, so happy to have us there. They’re very interested in learning about Candida auris and understanding what they could do to control it.”

While recent attention has been on the frightening levels of multidrug resistance in C. auris, Dr. Karmarkar concluded that the “central message in our investigation is that with the right effort, the right approach, and the right team this is an intervenable issue. It’s not inevitable if the attention is focused on it to pick it up early and then try to contain it.”

Dr. Karmarkar reports no relevant financial relationships. Dr. Diekema reports research funding from bioMerieux and consulting fees from Opgen.

A version of this article first appeared on Medscape.com.

Several health care-associated infections in U.S. hospitals spiked in 2020 compared to the previous year, according to a Centers for Disease Control and Prevention analysis published Sept. 2 in Infection Control and Hospital Epidemiology. Soaring hospitalization rates, sicker patients who required more frequent and intense care, and staffing and supply shortages caused by the COVID-19 pandemic are thought to have contributed to this increase.

This is the first increase in health care–associated infections since 2015.

These findings “are a reflection of the enormous stress that COVID has placed on our health care system,” Arjun Srinivasan, MD (Capt, USPHS), the associate director of the CDC’s Health care-Associated Infection Prevention Programs, Atlanta, told this news organization. He was not an author of the article, but he supervised the research. “We don’t want anyone to read this report and think that it represents a failure of the individual provider or a failure of health care providers in this country in their care of COVID patients,” he said. He noted that health care professionals have provided “tremendously good care to patients under extremely difficult circumstances.”

“People don’t fail – systems fail – and that’s what happened here,” he said. “Our systems that we need to have in place to prevent health care–associated infection simply were not as strong as they needed to be to survive this challenge.”

In the study, researchers used data reported to the National Healthcare Safety Network, the CDC’s tracking system for health care–associated infections. The team compared national standard infection ratios – calculated by dividing the number of reported infections by the number of predicted infections – between 2019 and 2020 for six routinely tracked events:

• Central line–associated bloodstream infections.
• Catheter-associated urinary tract infections (CAUTIs).
• Ventilator-associated events (VAEs).
• Infections associated with colon surgery and abdominal hysterectomy.
• Clostridioides difficile infections.
• Methicillin-resistant Staphylococcus aureus (MRSA) infections.

Infections were estimated using regression models created with baseline data from 2015.

“The new report highlights the need for health care facilities to strengthen their infection prevention programs and support them with adequate resources so that they can handle emerging threats to public health, while at the same time ensuring that gains made in combating HAIs [health care–associated infections] are not lost,” said the Association for Professionals in Infection Control and Epidemiology in a statement.

The analysis revealed significant national increases in central line–associated bloodstream infections, CAUTIs, VAEs, and MRSA infections in 2020 compared to 2019. Among all infection types, the greatest increase was in central-line infections, which were 46% to 47% higher in the third quarter and fourth quarter (Q4) of 2020 relative to the same periods the previous year. VAEs rose by 45%, MRSA infections increased by 34%, and CAUTIs increased by 19% in Q4 of 2020 compared to 2019.

The influx of sicker patients in hospitals throughout 2020 led to more frequent and longer use of medical devices such as catheters and ventilators. The use of these devices increases risk for infection, David P. Calfee, MD, chief medical epidemiologist at the New York–Presbyterian/Weill Cornell Medical Center, said in an interview. He is an editor of Infection Control and Hospital Epidemiology and was not involved with the study. Shortages in personal protective equipment and crowded intensive care units could also have affected how care was delivered, he said. These factors could have led to “reductions in the ability to provide some of the types of care that are needed to optimally reduce the risk of infection.”

There was either no change or decreases in infections associated with colon surgery or abdominal hysterectomy, likely because there were fewer elective surgeries performed, said Dr. Srinivasan. C. difficile–associated infections also decreased throughout 2020 compared to the previous year. Common practices to prevent the spread of COVID-19 in hospitals, such as environmental cleaning, use of personal protective equipment, and patient isolation, likely helped to curb the spread of C. difficile. Although these mitigating procedures do help protect against MRSA infection, many other factors, notably, the use of medical devices such as ventilators and catheters, can increase the risk for MRSA infection, Dr. Srinivasan added.

Although more research is needed to identify the reasons for these spikes in infection, the findings help quantify the scope of these increases across the United States, Dr. Calfee said. The data allow hospitals and health care professionals to “look back at what we did and then think forward in terms of what we can do different in the future,” he added, “so that these stresses to the system have less of an impact on how we are able to provide care.”

Dr. Srinivasan and Dr. Calfee report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Several health care-associated infections in U.S. hospitals spiked in 2020 compared to the previous year, according to a Centers for Disease Control and Prevention analysis published Sept. 2 in Infection Control and Hospital Epidemiology. Soaring hospitalization rates, sicker patients who required more frequent and intense care, and staffing and supply shortages caused by the COVID-19 pandemic are thought to have contributed to this increase.

This is the first increase in health care–associated infections since 2015.

These findings “are a reflection of the enormous stress that COVID has placed on our health care system,” Arjun Srinivasan, MD (Capt, USPHS), the associate director of the CDC’s Health care-Associated Infection Prevention Programs, Atlanta, told this news organization. He was not an author of the article, but he supervised the research. “We don’t want anyone to read this report and think that it represents a failure of the individual provider or a failure of health care providers in this country in their care of COVID patients,” he said. He noted that health care professionals have provided “tremendously good care to patients under extremely difficult circumstances.”

“People don’t fail – systems fail – and that’s what happened here,” he said. “Our systems that we need to have in place to prevent health care–associated infection simply were not as strong as they needed to be to survive this challenge.”

In the study, researchers used data reported to the National Healthcare Safety Network, the CDC’s tracking system for health care–associated infections. The team compared national standard infection ratios – calculated by dividing the number of reported infections by the number of predicted infections – between 2019 and 2020 for six routinely tracked events:

• Central line–associated bloodstream infections.
• Catheter-associated urinary tract infections (CAUTIs).
• Ventilator-associated events (VAEs).
• Infections associated with colon surgery and abdominal hysterectomy.
• Clostridioides difficile infections.
• Methicillin-resistant Staphylococcus aureus (MRSA) infections.

Infections were estimated using regression models created with baseline data from 2015.

“The new report highlights the need for health care facilities to strengthen their infection prevention programs and support them with adequate resources so that they can handle emerging threats to public health, while at the same time ensuring that gains made in combating HAIs [health care–associated infections] are not lost,” said the Association for Professionals in Infection Control and Epidemiology in a statement.

The analysis revealed significant national increases in central line–associated bloodstream infections, CAUTIs, VAEs, and MRSA infections in 2020 compared to 2019. Among all infection types, the greatest increase was in central-line infections, which were 46% to 47% higher in the third quarter and fourth quarter (Q4) of 2020 relative to the same periods the previous year. VAEs rose by 45%, MRSA infections increased by 34%, and CAUTIs increased by 19% in Q4 of 2020 compared to 2019.

The influx of sicker patients in hospitals throughout 2020 led to more frequent and longer use of medical devices such as catheters and ventilators. The use of these devices increases risk for infection, David P. Calfee, MD, chief medical epidemiologist at the New York–Presbyterian/Weill Cornell Medical Center, said in an interview. He is an editor of Infection Control and Hospital Epidemiology and was not involved with the study. Shortages in personal protective equipment and crowded intensive care units could also have affected how care was delivered, he said. These factors could have led to “reductions in the ability to provide some of the types of care that are needed to optimally reduce the risk of infection.”

There was either no change or decreases in infections associated with colon surgery or abdominal hysterectomy, likely because there were fewer elective surgeries performed, said Dr. Srinivasan. C. difficile–associated infections also decreased throughout 2020 compared to the previous year. Common practices to prevent the spread of COVID-19 in hospitals, such as environmental cleaning, use of personal protective equipment, and patient isolation, likely helped to curb the spread of C. difficile. Although these mitigating procedures do help protect against MRSA infection, many other factors, notably, the use of medical devices such as ventilators and catheters, can increase the risk for MRSA infection, Dr. Srinivasan added.

Although more research is needed to identify the reasons for these spikes in infection, the findings help quantify the scope of these increases across the United States, Dr. Calfee said. The data allow hospitals and health care professionals to “look back at what we did and then think forward in terms of what we can do different in the future,” he added, “so that these stresses to the system have less of an impact on how we are able to provide care.”

Dr. Srinivasan and Dr. Calfee report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Several health care-associated infections in U.S. hospitals spiked in 2020 compared to the previous year, according to a Centers for Disease Control and Prevention analysis published Sept. 2 in Infection Control and Hospital Epidemiology. Soaring hospitalization rates, sicker patients who required more frequent and intense care, and staffing and supply shortages caused by the COVID-19 pandemic are thought to have contributed to this increase.

This is the first increase in health care–associated infections since 2015.

These findings “are a reflection of the enormous stress that COVID has placed on our health care system,” Arjun Srinivasan, MD (Capt, USPHS), the associate director of the CDC’s Health care-Associated Infection Prevention Programs, Atlanta, told this news organization. He was not an author of the article, but he supervised the research. “We don’t want anyone to read this report and think that it represents a failure of the individual provider or a failure of health care providers in this country in their care of COVID patients,” he said. He noted that health care professionals have provided “tremendously good care to patients under extremely difficult circumstances.”

“People don’t fail – systems fail – and that’s what happened here,” he said. “Our systems that we need to have in place to prevent health care–associated infection simply were not as strong as they needed to be to survive this challenge.”

In the study, researchers used data reported to the National Healthcare Safety Network, the CDC’s tracking system for health care–associated infections. The team compared national standard infection ratios – calculated by dividing the number of reported infections by the number of predicted infections – between 2019 and 2020 for six routinely tracked events:

• Central line–associated bloodstream infections.
• Catheter-associated urinary tract infections (CAUTIs).
• Ventilator-associated events (VAEs).
• Infections associated with colon surgery and abdominal hysterectomy.
• Clostridioides difficile infections.
• Methicillin-resistant Staphylococcus aureus (MRSA) infections.

Infections were estimated using regression models created with baseline data from 2015.

“The new report highlights the need for health care facilities to strengthen their infection prevention programs and support them with adequate resources so that they can handle emerging threats to public health, while at the same time ensuring that gains made in combating HAIs [health care–associated infections] are not lost,” said the Association for Professionals in Infection Control and Epidemiology in a statement.

The analysis revealed significant national increases in central line–associated bloodstream infections, CAUTIs, VAEs, and MRSA infections in 2020 compared to 2019. Among all infection types, the greatest increase was in central-line infections, which were 46% to 47% higher in the third quarter and fourth quarter (Q4) of 2020 relative to the same periods the previous year. VAEs rose by 45%, MRSA infections increased by 34%, and CAUTIs increased by 19% in Q4 of 2020 compared to 2019.

The influx of sicker patients in hospitals throughout 2020 led to more frequent and longer use of medical devices such as catheters and ventilators. The use of these devices increases risk for infection, David P. Calfee, MD, chief medical epidemiologist at the New York–Presbyterian/Weill Cornell Medical Center, said in an interview. He is an editor of Infection Control and Hospital Epidemiology and was not involved with the study. Shortages in personal protective equipment and crowded intensive care units could also have affected how care was delivered, he said. These factors could have led to “reductions in the ability to provide some of the types of care that are needed to optimally reduce the risk of infection.”

There was either no change or decreases in infections associated with colon surgery or abdominal hysterectomy, likely because there were fewer elective surgeries performed, said Dr. Srinivasan. C. difficile–associated infections also decreased throughout 2020 compared to the previous year. Common practices to prevent the spread of COVID-19 in hospitals, such as environmental cleaning, use of personal protective equipment, and patient isolation, likely helped to curb the spread of C. difficile. Although these mitigating procedures do help protect against MRSA infection, many other factors, notably, the use of medical devices such as ventilators and catheters, can increase the risk for MRSA infection, Dr. Srinivasan added.

Although more research is needed to identify the reasons for these spikes in infection, the findings help quantify the scope of these increases across the United States, Dr. Calfee said. The data allow hospitals and health care professionals to “look back at what we did and then think forward in terms of what we can do different in the future,” he added, “so that these stresses to the system have less of an impact on how we are able to provide care.”

Dr. Srinivasan and Dr. Calfee report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The Centers for Disease Control and Prevention and Food and Drug Administration have announced an outbreak of at least 15 Burkholderia cepacia infections associated with contaminated ultrasound gel used to guide invasive procedures as well as an unrelated outbreak of Burkholderia pseudomallei that caused two deaths.

The procedures involved in the B. cepacia outbreak included placement of both central and peripheral intravenous catheters and paracentesis (removal of peritoneal fluid from the abdominal cavity). Cases have occurred in several states.

Further testing has shown the presence of Burkholderia stabilis, a member of B. cepacia complex (Bcc), in four lots of unopened bottles of MediChoice M500812 ultrasound gel. Eco-Med Pharmaceuticals of Etobicoke, Ont., the parent manufacturer, has issued a recall of MediChoice M500812 or Eco-Gel 200 with the following lot numbers: B029, B030, B031, B032, B040, B041, B048, B055. A similar outbreak occurred in Canada.

Some of these cases resulted in bloodstream infections. Further details are not yet available. Bcc infections have ranged from asymptomatic to life-threatening pneumonias, particularly in patients with cystic fibrosis. Other risk factors include immunosuppression, mechanical ventilation, and the use of other invasive venous or urinary catheters.

Kiran M. Perkins, MD, MPH, outbreak lead with the CDC’s Prevention Research Branch, said in an interview via email that automated systems such as Vitek might have trouble identifying the organism as “the system may only reveal the microbial species at the genus level but not at the species level, and/or it may have difficulty distinguishing between members of closely related group members.”

In the CDC’s experience, “most facilities do not conduct further species identification.” The agency added that it cannot tell if there has been any increase in cases associated with COVID-19, as they are not notifiable diseases and the “CDC does not systematically collect information on B. cepacia complex infections.”

Rodney Rohde, PhD, professor of clinical laboratory science and chair of the clinical laboratory science program, Texas State University, San Marcos, told this news organization via email that Burkholderia’s “detection in the manufacturing process is difficult, and product recalls are frequent.” He added, “A recent review by the Food and Drug Administration in the U.S. found that almost 40% of contamination reports in both sterile and nonsterile pharmaceutical products were caused by Bcc bacteria.” Another problem is that they often create biofilms, so “they are tenacious environmental colonizers of medical equipment and surfaces in general.”

There have been many other outbreaks as a result to B. cepacia complex. Because it is often in the water supply used in pharmaceutical manufacturing and is resistant to preservatives, the FDA cautions that it poses a risk of contamination in all nonsterile, water-based drug products.

Recalls have included contaminated antiseptics, such as povidone iodine, benzalkonium chloride, and chlorhexidine gluconate. Contamination in manufacturing may not be uniform, and only some samples may be affected. Antiseptic mouthwashes have also been affected. So have nonbacterial soaps and docusate (a stool softener) solutions, and various personal care products, including nasal sprays, lotions, simethicone gas relief drops (Mylicon), and baby wipes.

Although Bcc are considered “objectionable organisms,” there have been no strong or consistent standards for their detection from the U.S. Pharmacopeia, and some manufacturers reportedly underestimate the consequences of contamination. The FDA issued a guidance to manufacturers in 2017 on quality assurance and cleaning procedures. This is particularly important since preservatives are ineffective against Bcc, and sterility has to be insured at each step of production.

Burkholderia isolates are generally resistant to commonly used antibiotics. Treatment might therefore include a combination of two drugs (to try to limit the emergence of more resistance) such as ceftazidime, piperacillin, meropenem with trimethoprim-sulfamethoxazole, or a beta-lactam plus aminoglycoside.

Interestingly, an outbreak of Burkholderia pseudomallei was just reported by the CDC as well. This is a related gram-negative bacillus which is quite uncommon in the United States. It causes melioidosis, usually a tropical infection, which presents with nonspecific symptoms or serious pneumonia, abscesses, or bloodstream infections.

Four cases have been identified this year in Georgia, Kansas, Minnesota, and Texas, two of them fatal. It is usually acquired from soil or water. By genomic analysis, the four cases are felt to be related, but no common source of exposure has been identified. They also appear to be closely related to South Asian strains, although none of the patients had traveled internationally. Prolonged antibiotic therapy with ceftazidime or meropenem, followed by 3-6 months of trimethoprim-sulfamethoxazole, is often required.

In his email, Dr. Rohde stated, “Melioidosis causes cough, chest pain, high fever, headache or unexplained weight loss, but it may take 2-3 weeks for symptoms of melioidosis to appear after a person’s initial exposure to the bacteria. So, one could see how this might be overlooked as COVID per symptoms and per the limitations of laboratory identification.”

It’s essential for clinicians to recognize that automated microbiology identification systems can misidentify B. pseudomallei as B. cepacia and to ask the lab for more specialized molecular diagnostics, particularly when relatively unusual organisms are isolated.

Candice Hoffmann, a public affairs specialist at the CDC, told this news organization that “clinicians should consider melioidosis as a differential diagnosis in both adult and pediatric patients who are suspected to have a bacterial infection (pneumonia, sepsis, meningitis, wound) and are not responding to antibacterial treatment, even if they have not traveled outside of the continental United States.”

Dr. Rohde has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The Centers for Disease Control and Prevention and Food and Drug Administration have announced an outbreak of at least 15 Burkholderia cepacia infections associated with contaminated ultrasound gel used to guide invasive procedures as well as an unrelated outbreak of Burkholderia pseudomallei that caused two deaths.

The procedures involved in the B. cepacia outbreak included placement of both central and peripheral intravenous catheters and paracentesis (removal of peritoneal fluid from the abdominal cavity). Cases have occurred in several states.

Further testing has shown the presence of Burkholderia stabilis, a member of B. cepacia complex (Bcc), in four lots of unopened bottles of MediChoice M500812 ultrasound gel. Eco-Med Pharmaceuticals of Etobicoke, Ont., the parent manufacturer, has issued a recall of MediChoice M500812 or Eco-Gel 200 with the following lot numbers: B029, B030, B031, B032, B040, B041, B048, B055. A similar outbreak occurred in Canada.

Some of these cases resulted in bloodstream infections. Further details are not yet available. Bcc infections have ranged from asymptomatic to life-threatening pneumonias, particularly in patients with cystic fibrosis. Other risk factors include immunosuppression, mechanical ventilation, and the use of other invasive venous or urinary catheters.

Kiran M. Perkins, MD, MPH, outbreak lead with the CDC’s Prevention Research Branch, said in an interview via email that automated systems such as Vitek might have trouble identifying the organism as “the system may only reveal the microbial species at the genus level but not at the species level, and/or it may have difficulty distinguishing between members of closely related group members.”

In the CDC’s experience, “most facilities do not conduct further species identification.” The agency added that it cannot tell if there has been any increase in cases associated with COVID-19, as they are not notifiable diseases and the “CDC does not systematically collect information on B. cepacia complex infections.”

Rodney Rohde, PhD, professor of clinical laboratory science and chair of the clinical laboratory science program, Texas State University, San Marcos, told this news organization via email that Burkholderia’s “detection in the manufacturing process is difficult, and product recalls are frequent.” He added, “A recent review by the Food and Drug Administration in the U.S. found that almost 40% of contamination reports in both sterile and nonsterile pharmaceutical products were caused by Bcc bacteria.” Another problem is that they often create biofilms, so “they are tenacious environmental colonizers of medical equipment and surfaces in general.”

There have been many other outbreaks as a result to B. cepacia complex. Because it is often in the water supply used in pharmaceutical manufacturing and is resistant to preservatives, the FDA cautions that it poses a risk of contamination in all nonsterile, water-based drug products.

Recalls have included contaminated antiseptics, such as povidone iodine, benzalkonium chloride, and chlorhexidine gluconate. Contamination in manufacturing may not be uniform, and only some samples may be affected. Antiseptic mouthwashes have also been affected. So have nonbacterial soaps and docusate (a stool softener) solutions, and various personal care products, including nasal sprays, lotions, simethicone gas relief drops (Mylicon), and baby wipes.

Although Bcc are considered “objectionable organisms,” there have been no strong or consistent standards for their detection from the U.S. Pharmacopeia, and some manufacturers reportedly underestimate the consequences of contamination. The FDA issued a guidance to manufacturers in 2017 on quality assurance and cleaning procedures. This is particularly important since preservatives are ineffective against Bcc, and sterility has to be insured at each step of production.

Burkholderia isolates are generally resistant to commonly used antibiotics. Treatment might therefore include a combination of two drugs (to try to limit the emergence of more resistance) such as ceftazidime, piperacillin, meropenem with trimethoprim-sulfamethoxazole, or a beta-lactam plus aminoglycoside.

Interestingly, an outbreak of Burkholderia pseudomallei was just reported by the CDC as well. This is a related gram-negative bacillus which is quite uncommon in the United States. It causes melioidosis, usually a tropical infection, which presents with nonspecific symptoms or serious pneumonia, abscesses, or bloodstream infections.

Four cases have been identified this year in Georgia, Kansas, Minnesota, and Texas, two of them fatal. It is usually acquired from soil or water. By genomic analysis, the four cases are felt to be related, but no common source of exposure has been identified. They also appear to be closely related to South Asian strains, although none of the patients had traveled internationally. Prolonged antibiotic therapy with ceftazidime or meropenem, followed by 3-6 months of trimethoprim-sulfamethoxazole, is often required.

In his email, Dr. Rohde stated, “Melioidosis causes cough, chest pain, high fever, headache or unexplained weight loss, but it may take 2-3 weeks for symptoms of melioidosis to appear after a person’s initial exposure to the bacteria. So, one could see how this might be overlooked as COVID per symptoms and per the limitations of laboratory identification.”

It’s essential for clinicians to recognize that automated microbiology identification systems can misidentify B. pseudomallei as B. cepacia and to ask the lab for more specialized molecular diagnostics, particularly when relatively unusual organisms are isolated.

Candice Hoffmann, a public affairs specialist at the CDC, told this news organization that “clinicians should consider melioidosis as a differential diagnosis in both adult and pediatric patients who are suspected to have a bacterial infection (pneumonia, sepsis, meningitis, wound) and are not responding to antibacterial treatment, even if they have not traveled outside of the continental United States.”

Dr. Rohde has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The Centers for Disease Control and Prevention and Food and Drug Administration have announced an outbreak of at least 15 Burkholderia cepacia infections associated with contaminated ultrasound gel used to guide invasive procedures as well as an unrelated outbreak of Burkholderia pseudomallei that caused two deaths.

The procedures involved in the B. cepacia outbreak included placement of both central and peripheral intravenous catheters and paracentesis (removal of peritoneal fluid from the abdominal cavity). Cases have occurred in several states.

Further testing has shown the presence of Burkholderia stabilis, a member of B. cepacia complex (Bcc), in four lots of unopened bottles of MediChoice M500812 ultrasound gel. Eco-Med Pharmaceuticals of Etobicoke, Ont., the parent manufacturer, has issued a recall of MediChoice M500812 or Eco-Gel 200 with the following lot numbers: B029, B030, B031, B032, B040, B041, B048, B055. A similar outbreak occurred in Canada.

Some of these cases resulted in bloodstream infections. Further details are not yet available. Bcc infections have ranged from asymptomatic to life-threatening pneumonias, particularly in patients with cystic fibrosis. Other risk factors include immunosuppression, mechanical ventilation, and the use of other invasive venous or urinary catheters.

Kiran M. Perkins, MD, MPH, outbreak lead with the CDC’s Prevention Research Branch, said in an interview via email that automated systems such as Vitek might have trouble identifying the organism as “the system may only reveal the microbial species at the genus level but not at the species level, and/or it may have difficulty distinguishing between members of closely related group members.”

In the CDC’s experience, “most facilities do not conduct further species identification.” The agency added that it cannot tell if there has been any increase in cases associated with COVID-19, as they are not notifiable diseases and the “CDC does not systematically collect information on B. cepacia complex infections.”

Rodney Rohde, PhD, professor of clinical laboratory science and chair of the clinical laboratory science program, Texas State University, San Marcos, told this news organization via email that Burkholderia’s “detection in the manufacturing process is difficult, and product recalls are frequent.” He added, “A recent review by the Food and Drug Administration in the U.S. found that almost 40% of contamination reports in both sterile and nonsterile pharmaceutical products were caused by Bcc bacteria.” Another problem is that they often create biofilms, so “they are tenacious environmental colonizers of medical equipment and surfaces in general.”

There have been many other outbreaks as a result to B. cepacia complex. Because it is often in the water supply used in pharmaceutical manufacturing and is resistant to preservatives, the FDA cautions that it poses a risk of contamination in all nonsterile, water-based drug products.

Recalls have included contaminated antiseptics, such as povidone iodine, benzalkonium chloride, and chlorhexidine gluconate. Contamination in manufacturing may not be uniform, and only some samples may be affected. Antiseptic mouthwashes have also been affected. So have nonbacterial soaps and docusate (a stool softener) solutions, and various personal care products, including nasal sprays, lotions, simethicone gas relief drops (Mylicon), and baby wipes.

Although Bcc are considered “objectionable organisms,” there have been no strong or consistent standards for their detection from the U.S. Pharmacopeia, and some manufacturers reportedly underestimate the consequences of contamination. The FDA issued a guidance to manufacturers in 2017 on quality assurance and cleaning procedures. This is particularly important since preservatives are ineffective against Bcc, and sterility has to be insured at each step of production.

Burkholderia isolates are generally resistant to commonly used antibiotics. Treatment might therefore include a combination of two drugs (to try to limit the emergence of more resistance) such as ceftazidime, piperacillin, meropenem with trimethoprim-sulfamethoxazole, or a beta-lactam plus aminoglycoside.

Interestingly, an outbreak of Burkholderia pseudomallei was just reported by the CDC as well. This is a related gram-negative bacillus which is quite uncommon in the United States. It causes melioidosis, usually a tropical infection, which presents with nonspecific symptoms or serious pneumonia, abscesses, or bloodstream infections.

Four cases have been identified this year in Georgia, Kansas, Minnesota, and Texas, two of them fatal. It is usually acquired from soil or water. By genomic analysis, the four cases are felt to be related, but no common source of exposure has been identified. They also appear to be closely related to South Asian strains, although none of the patients had traveled internationally. Prolonged antibiotic therapy with ceftazidime or meropenem, followed by 3-6 months of trimethoprim-sulfamethoxazole, is often required.

In his email, Dr. Rohde stated, “Melioidosis causes cough, chest pain, high fever, headache or unexplained weight loss, but it may take 2-3 weeks for symptoms of melioidosis to appear after a person’s initial exposure to the bacteria. So, one could see how this might be overlooked as COVID per symptoms and per the limitations of laboratory identification.”

It’s essential for clinicians to recognize that automated microbiology identification systems can misidentify B. pseudomallei as B. cepacia and to ask the lab for more specialized molecular diagnostics, particularly when relatively unusual organisms are isolated.

Candice Hoffmann, a public affairs specialist at the CDC, told this news organization that “clinicians should consider melioidosis as a differential diagnosis in both adult and pediatric patients who are suspected to have a bacterial infection (pneumonia, sepsis, meningitis, wound) and are not responding to antibacterial treatment, even if they have not traveled outside of the continental United States.”

Dr. Rohde has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.