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Delayed appropriate therapy affects outcomes in patients at risk for CRE infections
SAN DIEGO – Among patients with serious infections due to Enterobacteriaceae, delayed appropriate therapy has a stronger association with outcomes, relative to presence of carbapenem-resistant Enterobacteriaceae, according to an analysis of national hospital data.
“We need to reconsider how we approach patients with serious Gram-negative infections,” lead study author Thomas Lodise, PharmD, PhD, said at an annual scientific meeting on infectious diseases. “We kind of take this wait-and-see approach in infectious diseases; we wait a couple of days, then we get aggressive. You would never do this in oncology. I don’t know how many more studies we need to show that early therapy matters. We talk about antibiotic stewardship. One of the fundamental pillars of stewardship is getting it right the first time, and we fail to do this in the majority of patients with serious Gram-negative infections.”
At the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society, he noted that delayed appropriate therapy is associated with increased rates of clinical failure and mortality, longer lengths of stay, longer durations of antibiotic treatment, and greater in-hospital costs. “Similarly, patients with infections caused by carbapenem-resistant Enterobacteriaceae (CRE) have poorer outcomes, such as increased risk of mortality or of being discharged to a long-term care facility, compared with patients with infections caused by carbapenem-susceptible Enterobacteriaceae isolates,” said Dr. Lodise of the Albany (N.Y.) College of Pharmacy and Health Sciences. “Although CRE and delayed appropriate therapy have both been associated with worse outcomes, the impact of each of these factors on clinical and economic outcomes is not well understood.”
In an effort to assess the independent and combined impact of CRE and delayed appropriate therapy on clinical and economic outcomes among hospitalized U.S. patients with serious infections due to Enterobacteriaceae, Dr. Lodise and his associates drew from the Premier Hospital Database, which includes information for about 500 acute-care hospitals in the United States, including the 150 hospitals that provided admission records and microbiological data assessed in the current analysis.
The researchers evaluated adults hospitalized between July 2011 and September 2014. The index date was defined as the earliest culture positive for at least one Gram-negative bacteria of interest, and patients were stratified based on whether the pathogen was CRE or non-CRE. Appropriate therapy was defined as receipt of an antibiotic regimen with microbiological activity against all pathogens identified within the index culture on the index date or within the subsequent 2-day period. All subsequent receipt of such therapy was defined as delayed appropriate therapy.
In all, 50,069 patients with a mean age of 66 years were included in the study. Of these, 514 (1%) harbored infections caused by CRE, and 49,555 (99%) had infections caused by a pathogen other than CRE. Multivariate adjusted analysis revealed significant differences between the CRE group and the non-CRE group in duration of antibiotic therapy (a mean of 8.5 days vs. 7.5 days, respectively); length of stay (a mean of 8.4 days vs. 7.6 days), and in-hospital cost (a mean of $19,816 vs. a mean of $15,165; P less than .01 for all associations). In addition, CRE patients were less likely to be discharged home (odds ratio [OR], .3) and more likely to die in the hospital or be discharged to hospice (OR, 2.2).
When outcomes of patients infections due to Enterobacteriaceae species were stratified by timing of appropriate therapy (timely vs. delayed) and CRE status (CRE vs. non-CRE), without exception the burden of serious infections was least among patients with infections due to non-CRE who received timely appropriate therapy, and greatest among patients with infections due to CRE in whom appropriate therapy was delayed. A gradient effect was observed across strata, and weighted towards timing of receipt of initial therapy. For example, the mean LOS post index culture date rank was lowest among non-CRE patients who received timely appropriate therapy (a mean of 5 days) and greatest among patients infected with CRE who received delayed appropriate therapy (a mean of 8.8 days). Similarly, mean in-hospital costs post index culture date rank was lowest among non-CRE patients who received timely appropriate therapy (a mean of $9,875) and greatest among patients infected with CRE who received delayed appropriate therapy (a mean of $25,506).
“This study demonstrates the importance of early identification of patients at risk for delayed appropriate therapy, through the use of clinical criteria for risk stratification or rapid diagnostic tools,” Dr. Lodise concluded. “The findings also highlight the need to shift current treatment practices away from antibiotic escalation strategies that contribute to delayed appropriate therapy and toward early aggressive, appropriate therapy in patients at risk for CRE infection.”
Allergan funded the study. Dr. Lodise disclosed that he has received consulting fees or honoraria from Allergan. He has also been a consultant for Merck, Achaogen, Zavante, and The Medicines Company.
SAN DIEGO – Among patients with serious infections due to Enterobacteriaceae, delayed appropriate therapy has a stronger association with outcomes, relative to presence of carbapenem-resistant Enterobacteriaceae, according to an analysis of national hospital data.
“We need to reconsider how we approach patients with serious Gram-negative infections,” lead study author Thomas Lodise, PharmD, PhD, said at an annual scientific meeting on infectious diseases. “We kind of take this wait-and-see approach in infectious diseases; we wait a couple of days, then we get aggressive. You would never do this in oncology. I don’t know how many more studies we need to show that early therapy matters. We talk about antibiotic stewardship. One of the fundamental pillars of stewardship is getting it right the first time, and we fail to do this in the majority of patients with serious Gram-negative infections.”
At the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society, he noted that delayed appropriate therapy is associated with increased rates of clinical failure and mortality, longer lengths of stay, longer durations of antibiotic treatment, and greater in-hospital costs. “Similarly, patients with infections caused by carbapenem-resistant Enterobacteriaceae (CRE) have poorer outcomes, such as increased risk of mortality or of being discharged to a long-term care facility, compared with patients with infections caused by carbapenem-susceptible Enterobacteriaceae isolates,” said Dr. Lodise of the Albany (N.Y.) College of Pharmacy and Health Sciences. “Although CRE and delayed appropriate therapy have both been associated with worse outcomes, the impact of each of these factors on clinical and economic outcomes is not well understood.”
In an effort to assess the independent and combined impact of CRE and delayed appropriate therapy on clinical and economic outcomes among hospitalized U.S. patients with serious infections due to Enterobacteriaceae, Dr. Lodise and his associates drew from the Premier Hospital Database, which includes information for about 500 acute-care hospitals in the United States, including the 150 hospitals that provided admission records and microbiological data assessed in the current analysis.
The researchers evaluated adults hospitalized between July 2011 and September 2014. The index date was defined as the earliest culture positive for at least one Gram-negative bacteria of interest, and patients were stratified based on whether the pathogen was CRE or non-CRE. Appropriate therapy was defined as receipt of an antibiotic regimen with microbiological activity against all pathogens identified within the index culture on the index date or within the subsequent 2-day period. All subsequent receipt of such therapy was defined as delayed appropriate therapy.
In all, 50,069 patients with a mean age of 66 years were included in the study. Of these, 514 (1%) harbored infections caused by CRE, and 49,555 (99%) had infections caused by a pathogen other than CRE. Multivariate adjusted analysis revealed significant differences between the CRE group and the non-CRE group in duration of antibiotic therapy (a mean of 8.5 days vs. 7.5 days, respectively); length of stay (a mean of 8.4 days vs. 7.6 days), and in-hospital cost (a mean of $19,816 vs. a mean of $15,165; P less than .01 for all associations). In addition, CRE patients were less likely to be discharged home (odds ratio [OR], .3) and more likely to die in the hospital or be discharged to hospice (OR, 2.2).
When outcomes of patients infections due to Enterobacteriaceae species were stratified by timing of appropriate therapy (timely vs. delayed) and CRE status (CRE vs. non-CRE), without exception the burden of serious infections was least among patients with infections due to non-CRE who received timely appropriate therapy, and greatest among patients with infections due to CRE in whom appropriate therapy was delayed. A gradient effect was observed across strata, and weighted towards timing of receipt of initial therapy. For example, the mean LOS post index culture date rank was lowest among non-CRE patients who received timely appropriate therapy (a mean of 5 days) and greatest among patients infected with CRE who received delayed appropriate therapy (a mean of 8.8 days). Similarly, mean in-hospital costs post index culture date rank was lowest among non-CRE patients who received timely appropriate therapy (a mean of $9,875) and greatest among patients infected with CRE who received delayed appropriate therapy (a mean of $25,506).
“This study demonstrates the importance of early identification of patients at risk for delayed appropriate therapy, through the use of clinical criteria for risk stratification or rapid diagnostic tools,” Dr. Lodise concluded. “The findings also highlight the need to shift current treatment practices away from antibiotic escalation strategies that contribute to delayed appropriate therapy and toward early aggressive, appropriate therapy in patients at risk for CRE infection.”
Allergan funded the study. Dr. Lodise disclosed that he has received consulting fees or honoraria from Allergan. He has also been a consultant for Merck, Achaogen, Zavante, and The Medicines Company.
SAN DIEGO – Among patients with serious infections due to Enterobacteriaceae, delayed appropriate therapy has a stronger association with outcomes, relative to presence of carbapenem-resistant Enterobacteriaceae, according to an analysis of national hospital data.
“We need to reconsider how we approach patients with serious Gram-negative infections,” lead study author Thomas Lodise, PharmD, PhD, said at an annual scientific meeting on infectious diseases. “We kind of take this wait-and-see approach in infectious diseases; we wait a couple of days, then we get aggressive. You would never do this in oncology. I don’t know how many more studies we need to show that early therapy matters. We talk about antibiotic stewardship. One of the fundamental pillars of stewardship is getting it right the first time, and we fail to do this in the majority of patients with serious Gram-negative infections.”
At the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society, he noted that delayed appropriate therapy is associated with increased rates of clinical failure and mortality, longer lengths of stay, longer durations of antibiotic treatment, and greater in-hospital costs. “Similarly, patients with infections caused by carbapenem-resistant Enterobacteriaceae (CRE) have poorer outcomes, such as increased risk of mortality or of being discharged to a long-term care facility, compared with patients with infections caused by carbapenem-susceptible Enterobacteriaceae isolates,” said Dr. Lodise of the Albany (N.Y.) College of Pharmacy and Health Sciences. “Although CRE and delayed appropriate therapy have both been associated with worse outcomes, the impact of each of these factors on clinical and economic outcomes is not well understood.”
In an effort to assess the independent and combined impact of CRE and delayed appropriate therapy on clinical and economic outcomes among hospitalized U.S. patients with serious infections due to Enterobacteriaceae, Dr. Lodise and his associates drew from the Premier Hospital Database, which includes information for about 500 acute-care hospitals in the United States, including the 150 hospitals that provided admission records and microbiological data assessed in the current analysis.
The researchers evaluated adults hospitalized between July 2011 and September 2014. The index date was defined as the earliest culture positive for at least one Gram-negative bacteria of interest, and patients were stratified based on whether the pathogen was CRE or non-CRE. Appropriate therapy was defined as receipt of an antibiotic regimen with microbiological activity against all pathogens identified within the index culture on the index date or within the subsequent 2-day period. All subsequent receipt of such therapy was defined as delayed appropriate therapy.
In all, 50,069 patients with a mean age of 66 years were included in the study. Of these, 514 (1%) harbored infections caused by CRE, and 49,555 (99%) had infections caused by a pathogen other than CRE. Multivariate adjusted analysis revealed significant differences between the CRE group and the non-CRE group in duration of antibiotic therapy (a mean of 8.5 days vs. 7.5 days, respectively); length of stay (a mean of 8.4 days vs. 7.6 days), and in-hospital cost (a mean of $19,816 vs. a mean of $15,165; P less than .01 for all associations). In addition, CRE patients were less likely to be discharged home (odds ratio [OR], .3) and more likely to die in the hospital or be discharged to hospice (OR, 2.2).
When outcomes of patients infections due to Enterobacteriaceae species were stratified by timing of appropriate therapy (timely vs. delayed) and CRE status (CRE vs. non-CRE), without exception the burden of serious infections was least among patients with infections due to non-CRE who received timely appropriate therapy, and greatest among patients with infections due to CRE in whom appropriate therapy was delayed. A gradient effect was observed across strata, and weighted towards timing of receipt of initial therapy. For example, the mean LOS post index culture date rank was lowest among non-CRE patients who received timely appropriate therapy (a mean of 5 days) and greatest among patients infected with CRE who received delayed appropriate therapy (a mean of 8.8 days). Similarly, mean in-hospital costs post index culture date rank was lowest among non-CRE patients who received timely appropriate therapy (a mean of $9,875) and greatest among patients infected with CRE who received delayed appropriate therapy (a mean of $25,506).
“This study demonstrates the importance of early identification of patients at risk for delayed appropriate therapy, through the use of clinical criteria for risk stratification or rapid diagnostic tools,” Dr. Lodise concluded. “The findings also highlight the need to shift current treatment practices away from antibiotic escalation strategies that contribute to delayed appropriate therapy and toward early aggressive, appropriate therapy in patients at risk for CRE infection.”
Allergan funded the study. Dr. Lodise disclosed that he has received consulting fees or honoraria from Allergan. He has also been a consultant for Merck, Achaogen, Zavante, and The Medicines Company.
REPORTING FROM ID WEEK 2017
Key clinical point:
Major finding: The mean LOS post index culture date rank was lowest among non-CRE patients who received timely appropriate therapy (a mean of 5 days) and greatest among patients infected with CRE who received delayed appropriate therapy (a mean of 8.8 days).
Study details: An analysis of 50,069 adults hospitalized with serious infections due to Enterobacteriaceae between July 2011 and September 2014.
Disclosures: Allergan funded the study. Dr. Lodise disclosed that he has received consulting fees or honoraria from Allergan. He also has been a consultant for Merck, Achaogen, Zavante, and The Medicines Company.
Negative nasal swabs reliably predicted no MRSA infection
SAN DIEGO – , said Darunee Chotiprasitsakul, MD, of Johns Hopkins Medicine in Baltimore.
But physicians often prescribed vancomycin anyway, accumulating nearly 7,400 potentially avoidable treatment days over a 19-month period, she said during an oral presentation at an annual meeting on infectious diseases.
Current guidelines recommend empiric vancomycin to cover MRSA infection when ill patients have a history of MRSA colonization or recent hospitalization or exposure to antibiotics. Patients whose nasal screening swabs are negative for MRSA have been shown to be at low risk of subsequent infection, but guidelines don’t address how to use swab results to guide decisions about empiric vancomycin, Dr. Chotiprasitsakul said.
Therefore, she and her associates studied 11,882 adults without historical MRSA infection or colonization who received nasal swabs for routine surveillance in adult ICUs at Johns Hopkins. A total of 441 patients (4%) had positive swabs, while 96% tested negative.
Among patients with negative swabs, only 25 (0.22%) developed MRSA infection requiring treatment. Thus, the negative predictive value of a nasal swab for MRSA was 99%, making the probability of infection despite a negative swab “exceedingly low,” Dr. Chotiprasitsakul said.
But clinicians seemed not to use negative swab results to curtail vancomycin therapy, she found. Rates of empiric vancomycin use were 36% among patients with positive swabs and 39% among those with negative swabs. Over 19 months, ICU patients received 7,371 avoidable days of vancomycin, a median of 3 days per patient.
Matching patients by ICU and days at risk identified no significant predictors of MRSA infection, Dr. Chotiprasitsakul said. Johns Hopkins Medicine has robust infection control practices, high compliance with hand hygiene and contact precautions, and low rates of nosocomial MRSA transmission, she noted. The predictive value of a negative MRSA nasal swab could be lower at institutions where that isn’t the case, she said.
Johns Hopkins is working to curtail unnecessary use of vancomycin, said senior author Sara Cosgrove, MD, professor of medicine in infectious diseases and director of the department of antimicrobial stewardship. The team has added the findings to its guidelines for antibiotic use, which are available in an app for Johns Hopkins providers, she said in an interview.
The stewardship also highlights the data when discussing starting and stopping vancomycin in patients at very low risk for MRSA infections, she said. “In general, providers have responded favorably to acting upon this new information,” Dr. Cosgrove noted.
Johns Hopkins continues to track median days of vancomycin use per patient and per 1,000 days in its units. “[We] will assess if there is an impact on vancomycin use over the coming year,” said Dr. Cosgrove.
The investigators had no conflicts of interest. The event marked the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.
SAN DIEGO – , said Darunee Chotiprasitsakul, MD, of Johns Hopkins Medicine in Baltimore.
But physicians often prescribed vancomycin anyway, accumulating nearly 7,400 potentially avoidable treatment days over a 19-month period, she said during an oral presentation at an annual meeting on infectious diseases.
Current guidelines recommend empiric vancomycin to cover MRSA infection when ill patients have a history of MRSA colonization or recent hospitalization or exposure to antibiotics. Patients whose nasal screening swabs are negative for MRSA have been shown to be at low risk of subsequent infection, but guidelines don’t address how to use swab results to guide decisions about empiric vancomycin, Dr. Chotiprasitsakul said.
Therefore, she and her associates studied 11,882 adults without historical MRSA infection or colonization who received nasal swabs for routine surveillance in adult ICUs at Johns Hopkins. A total of 441 patients (4%) had positive swabs, while 96% tested negative.
Among patients with negative swabs, only 25 (0.22%) developed MRSA infection requiring treatment. Thus, the negative predictive value of a nasal swab for MRSA was 99%, making the probability of infection despite a negative swab “exceedingly low,” Dr. Chotiprasitsakul said.
But clinicians seemed not to use negative swab results to curtail vancomycin therapy, she found. Rates of empiric vancomycin use were 36% among patients with positive swabs and 39% among those with negative swabs. Over 19 months, ICU patients received 7,371 avoidable days of vancomycin, a median of 3 days per patient.
Matching patients by ICU and days at risk identified no significant predictors of MRSA infection, Dr. Chotiprasitsakul said. Johns Hopkins Medicine has robust infection control practices, high compliance with hand hygiene and contact precautions, and low rates of nosocomial MRSA transmission, she noted. The predictive value of a negative MRSA nasal swab could be lower at institutions where that isn’t the case, she said.
Johns Hopkins is working to curtail unnecessary use of vancomycin, said senior author Sara Cosgrove, MD, professor of medicine in infectious diseases and director of the department of antimicrobial stewardship. The team has added the findings to its guidelines for antibiotic use, which are available in an app for Johns Hopkins providers, she said in an interview.
The stewardship also highlights the data when discussing starting and stopping vancomycin in patients at very low risk for MRSA infections, she said. “In general, providers have responded favorably to acting upon this new information,” Dr. Cosgrove noted.
Johns Hopkins continues to track median days of vancomycin use per patient and per 1,000 days in its units. “[We] will assess if there is an impact on vancomycin use over the coming year,” said Dr. Cosgrove.
The investigators had no conflicts of interest. The event marked the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.
SAN DIEGO – , said Darunee Chotiprasitsakul, MD, of Johns Hopkins Medicine in Baltimore.
But physicians often prescribed vancomycin anyway, accumulating nearly 7,400 potentially avoidable treatment days over a 19-month period, she said during an oral presentation at an annual meeting on infectious diseases.
Current guidelines recommend empiric vancomycin to cover MRSA infection when ill patients have a history of MRSA colonization or recent hospitalization or exposure to antibiotics. Patients whose nasal screening swabs are negative for MRSA have been shown to be at low risk of subsequent infection, but guidelines don’t address how to use swab results to guide decisions about empiric vancomycin, Dr. Chotiprasitsakul said.
Therefore, she and her associates studied 11,882 adults without historical MRSA infection or colonization who received nasal swabs for routine surveillance in adult ICUs at Johns Hopkins. A total of 441 patients (4%) had positive swabs, while 96% tested negative.
Among patients with negative swabs, only 25 (0.22%) developed MRSA infection requiring treatment. Thus, the negative predictive value of a nasal swab for MRSA was 99%, making the probability of infection despite a negative swab “exceedingly low,” Dr. Chotiprasitsakul said.
But clinicians seemed not to use negative swab results to curtail vancomycin therapy, she found. Rates of empiric vancomycin use were 36% among patients with positive swabs and 39% among those with negative swabs. Over 19 months, ICU patients received 7,371 avoidable days of vancomycin, a median of 3 days per patient.
Matching patients by ICU and days at risk identified no significant predictors of MRSA infection, Dr. Chotiprasitsakul said. Johns Hopkins Medicine has robust infection control practices, high compliance with hand hygiene and contact precautions, and low rates of nosocomial MRSA transmission, she noted. The predictive value of a negative MRSA nasal swab could be lower at institutions where that isn’t the case, she said.
Johns Hopkins is working to curtail unnecessary use of vancomycin, said senior author Sara Cosgrove, MD, professor of medicine in infectious diseases and director of the department of antimicrobial stewardship. The team has added the findings to its guidelines for antibiotic use, which are available in an app for Johns Hopkins providers, she said in an interview.
The stewardship also highlights the data when discussing starting and stopping vancomycin in patients at very low risk for MRSA infections, she said. “In general, providers have responded favorably to acting upon this new information,” Dr. Cosgrove noted.
Johns Hopkins continues to track median days of vancomycin use per patient and per 1,000 days in its units. “[We] will assess if there is an impact on vancomycin use over the coming year,” said Dr. Cosgrove.
The investigators had no conflicts of interest. The event marked the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.
AT IDWEEK 2017
Key clinical point: Only 0.2% of ICU patients with negative surveillance nasal swabs developed MRSA infections during the same hospitalization.
Major finding: The predictive value of a negative swab was 99%.
Data source: A study of 11,882 adults without historical MRSA infection or colonization who received nasal swabs for routine surveillance.
Disclosures: The investigators had no conflicts of interest.
VA study finds high MRSA infection risk among those colonized with the bacterium
SAN DIEGO – Patients colonized with MRSA are at high risk of MRSA infection both in the predischarge and postdischarge time periods, results from an 8-year Veterans Affairs study showed.
“MRSA colonization is recognized as being a strong predictor of subsequent infection,” Richard E. Nelson, PhD, said at an annual scientific meeting on infectious diseases. “What’s less understood is, are there differences in infection rates among patients who are colonized at different times? And, is there a difference between patients who import colonization with them to a hospital versus those who acquire it during a hospital stay? In addition, infection control efforts mainly focus on the predischarge time period. What about infections that develop post discharge?”
In an effort to investigate these questions, Dr. Nelson of the VA Salt Lake City Healthcare System, and his associates, evaluated more than 1.3 million acute care inpatient admissions to 125 VA hospitals nationwide from January 2008 through December 2015 who had surveillance tests performed for MRSA carriage. 
The researchers restricted admissions to individuals with at least 365 days of VA activity prior to admission and categorized them into three groups: no colonization (defined as those who had no positive surveillance tests (n = 1,196,928); importation (defined as those who tested positive for MRSA colonization on admission (n = 95,833); and acquisition (defined as those who did not test positive for MRSA on admission but tested positive on a subsequent surveillance test during their admission (n = 15,146). Next, they captured MRSA infections in these individuals prior to discharge and at 30 and 90 days post discharge. Infections were defined as positive MRSA cultures taken from sterile sites, including blood, catheter site, or bone.
Overall, patients were in their mid-60s, and those who imported MRSA and those who acquired it were more likely to be male, less likely to be married, and more likely to not have health insurance. , which peaked in 2010 and declined through 2015,” said Dr. Nelson, who also holds a faculty position in University of Utah’s department of internal medicine, in the division of epidemiology. Specifically, the proportion of predischarge MRSA infections, compared with 30 days post discharge, were 40.4% vs. 59.6%, respectively, in the no colonization group; 63% vs. 37% in the importation group, and 80.8% vs. 19.2% in the acquisition group.
He also reported that the proportion of predischarge MRSA infections, compared with 90 days post discharge, were 20.5% vs. 79.5%, respectively, in the no colonization group; 47.3% vs. 52.7% in the importation group, and 70.5% vs. 29.5% in the acquisition group. The time from acquisition to infection was a mean of 8.7 days in the 30-day analysis and a mean of 22.4 days in the 90-day analysis.
Multivariate logistic regression revealed that the impact of colonization status on infection was highest in the acquisition group, compared with the importation group. Specifically, the odds ratio of developing a MRSA infection among the importation group was 29.22 in the predischarge period, OR 10.87 at post discharge 30 days, and OR 7.64 at post discharge 90 days (P less than .001 for all). Meanwhile, the OR among the acquisition group was 85.19 in the predischarge period, OR 13.01 at post discharge 30 days, and OR 8.26 at post discharge 90 days (P less than .001 for all).
Dr. Nelson acknowledged certain limitations of the study, including the fact that it only identified postdischarge infections that were detected in a VA facility. “This is likely an underestimate of postdischarge infections, because we’re missing the infection that occur in non-VA facilities,” he said at the event, which marked the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society. “Also, patients can be colonized in many different body locations, but the VA protocol is that the surveillance test be done in the nostrils. So we may have misclassified patients who were colonized in a different body location as being uncolonized, when in fact they were colonized.”
The study was funded by a grant from the VA. Dr. Nelson reported having no financial disclosures.
SAN DIEGO – Patients colonized with MRSA are at high risk of MRSA infection both in the predischarge and postdischarge time periods, results from an 8-year Veterans Affairs study showed.
“MRSA colonization is recognized as being a strong predictor of subsequent infection,” Richard E. Nelson, PhD, said at an annual scientific meeting on infectious diseases. “What’s less understood is, are there differences in infection rates among patients who are colonized at different times? And, is there a difference between patients who import colonization with them to a hospital versus those who acquire it during a hospital stay? In addition, infection control efforts mainly focus on the predischarge time period. What about infections that develop post discharge?”
In an effort to investigate these questions, Dr. Nelson of the VA Salt Lake City Healthcare System, and his associates, evaluated more than 1.3 million acute care inpatient admissions to 125 VA hospitals nationwide from January 2008 through December 2015 who had surveillance tests performed for MRSA carriage.
The researchers restricted admissions to individuals with at least 365 days of VA activity prior to admission and categorized them into three groups: no colonization (defined as those who had no positive surveillance tests (n = 1,196,928); importation (defined as those who tested positive for MRSA colonization on admission (n = 95,833); and acquisition (defined as those who did not test positive for MRSA on admission but tested positive on a subsequent surveillance test during their admission (n = 15,146). Next, they captured MRSA infections in these individuals prior to discharge and at 30 and 90 days post discharge. Infections were defined as positive MRSA cultures taken from sterile sites, including blood, catheter site, or bone.
Overall, patients were in their mid-60s, and those who imported MRSA and those who acquired it were more likely to be male, less likely to be married, and more likely to not have health insurance. , which peaked in 2010 and declined through 2015,” said Dr. Nelson, who also holds a faculty position in University of Utah’s department of internal medicine, in the division of epidemiology. Specifically, the proportion of predischarge MRSA infections, compared with 30 days post discharge, were 40.4% vs. 59.6%, respectively, in the no colonization group; 63% vs. 37% in the importation group, and 80.8% vs. 19.2% in the acquisition group.
He also reported that the proportion of predischarge MRSA infections, compared with 90 days post discharge, were 20.5% vs. 79.5%, respectively, in the no colonization group; 47.3% vs. 52.7% in the importation group, and 70.5% vs. 29.5% in the acquisition group. The time from acquisition to infection was a mean of 8.7 days in the 30-day analysis and a mean of 22.4 days in the 90-day analysis.
Multivariate logistic regression revealed that the impact of colonization status on infection was highest in the acquisition group, compared with the importation group. Specifically, the odds ratio of developing a MRSA infection among the importation group was 29.22 in the predischarge period, OR 10.87 at post discharge 30 days, and OR 7.64 at post discharge 90 days (P less than .001 for all). Meanwhile, the OR among the acquisition group was 85.19 in the predischarge period, OR 13.01 at post discharge 30 days, and OR 8.26 at post discharge 90 days (P less than .001 for all).
Dr. Nelson acknowledged certain limitations of the study, including the fact that it only identified postdischarge infections that were detected in a VA facility. “This is likely an underestimate of postdischarge infections, because we’re missing the infection that occur in non-VA facilities,” he said at the event, which marked the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society. “Also, patients can be colonized in many different body locations, but the VA protocol is that the surveillance test be done in the nostrils. So we may have misclassified patients who were colonized in a different body location as being uncolonized, when in fact they were colonized.”
The study was funded by a grant from the VA. Dr. Nelson reported having no financial disclosures.
SAN DIEGO – Patients colonized with MRSA are at high risk of MRSA infection both in the predischarge and postdischarge time periods, results from an 8-year Veterans Affairs study showed.
“MRSA colonization is recognized as being a strong predictor of subsequent infection,” Richard E. Nelson, PhD, said at an annual scientific meeting on infectious diseases. “What’s less understood is, are there differences in infection rates among patients who are colonized at different times? And, is there a difference between patients who import colonization with them to a hospital versus those who acquire it during a hospital stay? In addition, infection control efforts mainly focus on the predischarge time period. What about infections that develop post discharge?”
In an effort to investigate these questions, Dr. Nelson of the VA Salt Lake City Healthcare System, and his associates, evaluated more than 1.3 million acute care inpatient admissions to 125 VA hospitals nationwide from January 2008 through December 2015 who had surveillance tests performed for MRSA carriage.
The researchers restricted admissions to individuals with at least 365 days of VA activity prior to admission and categorized them into three groups: no colonization (defined as those who had no positive surveillance tests (n = 1,196,928); importation (defined as those who tested positive for MRSA colonization on admission (n = 95,833); and acquisition (defined as those who did not test positive for MRSA on admission but tested positive on a subsequent surveillance test during their admission (n = 15,146). Next, they captured MRSA infections in these individuals prior to discharge and at 30 and 90 days post discharge. Infections were defined as positive MRSA cultures taken from sterile sites, including blood, catheter site, or bone.
Overall, patients were in their mid-60s, and those who imported MRSA and those who acquired it were more likely to be male, less likely to be married, and more likely to not have health insurance. , which peaked in 2010 and declined through 2015,” said Dr. Nelson, who also holds a faculty position in University of Utah’s department of internal medicine, in the division of epidemiology. Specifically, the proportion of predischarge MRSA infections, compared with 30 days post discharge, were 40.4% vs. 59.6%, respectively, in the no colonization group; 63% vs. 37% in the importation group, and 80.8% vs. 19.2% in the acquisition group.
He also reported that the proportion of predischarge MRSA infections, compared with 90 days post discharge, were 20.5% vs. 79.5%, respectively, in the no colonization group; 47.3% vs. 52.7% in the importation group, and 70.5% vs. 29.5% in the acquisition group. The time from acquisition to infection was a mean of 8.7 days in the 30-day analysis and a mean of 22.4 days in the 90-day analysis.
Multivariate logistic regression revealed that the impact of colonization status on infection was highest in the acquisition group, compared with the importation group. Specifically, the odds ratio of developing a MRSA infection among the importation group was 29.22 in the predischarge period, OR 10.87 at post discharge 30 days, and OR 7.64 at post discharge 90 days (P less than .001 for all). Meanwhile, the OR among the acquisition group was 85.19 in the predischarge period, OR 13.01 at post discharge 30 days, and OR 8.26 at post discharge 90 days (P less than .001 for all).
Dr. Nelson acknowledged certain limitations of the study, including the fact that it only identified postdischarge infections that were detected in a VA facility. “This is likely an underestimate of postdischarge infections, because we’re missing the infection that occur in non-VA facilities,” he said at the event, which marked the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society. “Also, patients can be colonized in many different body locations, but the VA protocol is that the surveillance test be done in the nostrils. So we may have misclassified patients who were colonized in a different body location as being uncolonized, when in fact they were colonized.”
The study was funded by a grant from the VA. Dr. Nelson reported having no financial disclosures.
REPORTING FROM ID WEEK 2017
Key clinical point: About half of postdischarge MRSA infections were in patients who acquired the organism before discharge.
Major finding: The proportion of predischarge MRSA infections, compared with 30 days post discharge, were 40.4% vs. 59.6%, respectively, in the no colonization group; 63% vs. 37% in the importation group, and 80.8% vs. 19.2% in the acquisition group.
Study details: An analysis of more than 1.3 million acute care inpatient admissions to 125 VA hospitals nationwide from January 2008 through December 2015.
Disclosures: The study was funded by a grant from the VA. Dr. Nelson reported having no financial disclosures.
Ribaxamase reduced new CDI infection by 71%
SAN DIEGO – , results from a phase 2b study showed.
At an annual scientific meeting on infectious diseases, lead investigator John F. Kokai-Kun, PhD, said that the finding represents a paradigm shift in the use of intravenous beta-lactam antibiotics to prevent opportunistic infections. “We currently treat Clostridium difficile infection (CDI) with antibiotics, which attack the vegetative cells,” said Dr. Kokai-Kun, vice president of nonclinical affairs for Rockville, Md.–based Synthetic Biologics, which is developing ribaxamase. “Since C. diff. is primarily a toxin-mediated disease, certain products seem to neutralize the toxin. There’s also been work with probiotics and prebiotics to try to strengthen and repair the dysbiotic colon. Fecal replacement therapy has been shown to be fairly effective for treatment of recurrent C. diff. infection. What if we could simply block the initial insult that leads to this cascade? That’s the damage caused to the gut microbiome by the antibiotic that’s excreted to the intestine.”
That’s where ribaxamase comes in, he said at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society. Ribaxamase is an orally administered beta-lactamase designed to degrade penicillin and cephalosporins in the intestinal lumen. It’s formulated for release in the proximal small intestine and is expected to be given during or a short time after administration of IV beta-lactam antibiotics such as ceftriaxone. “This is expected to degrade the excess antibiotics that are excreted into the small intestine via the bile,” Dr. Kokai-Kun explained. “It’s designed to prevent disruption of the gut microbiome and thus protect from opportunistic GI infections like CDI.” Early-stage clinical studies demonstrated that ribaxamase was well tolerated and that it is not systemically absorbed, while phase 2 studies showed that ribaxamase degrades ceftriaxone in the intestine to below the level of detection while not affecting the pharmacokinetics of ceftriaxone in the plasma.
For the current study, 412 patients were enrolled at 84 multinational clinical sites. These patients were admitted to the hospital for treatment of a lower respiratory tract infection and were randomized 1:1 to receive ceftriaxone plus 150 mg ribaxamase or ceftriaxone plus placebo. Patients in both groups could also receive an oral macrolide at the discretion of the clinical investigator. The researchers also obtained fecal samples at screening, 72 hours post antibiotic treatment, and at the end of a 4-week follow-up visit, to determine colonization by opportunistic pathogens and to examine changes in the gut microbiome. Patients were monitored for 6 weeks for diarrhea and CDI. Diarrhea was defined as three or more loose or watery stools in a 24-hour period. “If that occurred, then we collected a sample, which was sent to the local lab to determine the presence of C. difficile toxins,” Dr. Kokai-Kun said.
The average age of study participants was 70 years, and about one-third in each arm received oral macrolides. The number of adverse events and serious adverse events were similar between active and placebo arms, and there was no trend associated with ribaxamase use. The lower respiratory tract infection cure rate to the ceftriaxone treatment was about 99% in both arms at 72 hours post treatment and at 2 weeks post treatment.
To analyze changes in the gut microbiome, the researchers conducted 16S rRNA sequencing of DNA extracted from fecal samples. In all, 652 samples were sequenced from 229 patients. Results from that analysis suggests that ribaxamase “appears to protect the gut microbiome from the onslaught of the ceftriaxone,” he said.
Ribaxamase reduced the incidence of new-onset CDI by 71%, compared with placebo (P = .045). “It apparently did this by protecting the integrity of the gut microbiome,” Dr. Kokai-Kun said. “There was also a significant reduction of new colonization by vancomycin-resistant enterococci at 72 hours and 4 weeks (P = .0001 and P = .0002, respectively) which is an opportunistic pathogen that is known to be able to inhabit gut microbiome when there is dysbiosis.”
The study was sponsored by Synthetic Biologics. Dr. Kokai-Kun is an employee of the company.
SAN DIEGO – , results from a phase 2b study showed.
At an annual scientific meeting on infectious diseases, lead investigator John F. Kokai-Kun, PhD, said that the finding represents a paradigm shift in the use of intravenous beta-lactam antibiotics to prevent opportunistic infections. “We currently treat Clostridium difficile infection (CDI) with antibiotics, which attack the vegetative cells,” said Dr. Kokai-Kun, vice president of nonclinical affairs for Rockville, Md.–based Synthetic Biologics, which is developing ribaxamase. “Since C. diff. is primarily a toxin-mediated disease, certain products seem to neutralize the toxin. There’s also been work with probiotics and prebiotics to try to strengthen and repair the dysbiotic colon. Fecal replacement therapy has been shown to be fairly effective for treatment of recurrent C. diff. infection. What if we could simply block the initial insult that leads to this cascade? That’s the damage caused to the gut microbiome by the antibiotic that’s excreted to the intestine.”
That’s where ribaxamase comes in, he said at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society. Ribaxamase is an orally administered beta-lactamase designed to degrade penicillin and cephalosporins in the intestinal lumen. It’s formulated for release in the proximal small intestine and is expected to be given during or a short time after administration of IV beta-lactam antibiotics such as ceftriaxone. “This is expected to degrade the excess antibiotics that are excreted into the small intestine via the bile,” Dr. Kokai-Kun explained. “It’s designed to prevent disruption of the gut microbiome and thus protect from opportunistic GI infections like CDI.” Early-stage clinical studies demonstrated that ribaxamase was well tolerated and that it is not systemically absorbed, while phase 2 studies showed that ribaxamase degrades ceftriaxone in the intestine to below the level of detection while not affecting the pharmacokinetics of ceftriaxone in the plasma.
For the current study, 412 patients were enrolled at 84 multinational clinical sites. These patients were admitted to the hospital for treatment of a lower respiratory tract infection and were randomized 1:1 to receive ceftriaxone plus 150 mg ribaxamase or ceftriaxone plus placebo. Patients in both groups could also receive an oral macrolide at the discretion of the clinical investigator. The researchers also obtained fecal samples at screening, 72 hours post antibiotic treatment, and at the end of a 4-week follow-up visit, to determine colonization by opportunistic pathogens and to examine changes in the gut microbiome. Patients were monitored for 6 weeks for diarrhea and CDI. Diarrhea was defined as three or more loose or watery stools in a 24-hour period. “If that occurred, then we collected a sample, which was sent to the local lab to determine the presence of C. difficile toxins,” Dr. Kokai-Kun said.
The average age of study participants was 70 years, and about one-third in each arm received oral macrolides. The number of adverse events and serious adverse events were similar between active and placebo arms, and there was no trend associated with ribaxamase use. The lower respiratory tract infection cure rate to the ceftriaxone treatment was about 99% in both arms at 72 hours post treatment and at 2 weeks post treatment.
To analyze changes in the gut microbiome, the researchers conducted 16S rRNA sequencing of DNA extracted from fecal samples. In all, 652 samples were sequenced from 229 patients. Results from that analysis suggests that ribaxamase “appears to protect the gut microbiome from the onslaught of the ceftriaxone,” he said.
Ribaxamase reduced the incidence of new-onset CDI by 71%, compared with placebo (P = .045). “It apparently did this by protecting the integrity of the gut microbiome,” Dr. Kokai-Kun said. “There was also a significant reduction of new colonization by vancomycin-resistant enterococci at 72 hours and 4 weeks (P = .0001 and P = .0002, respectively) which is an opportunistic pathogen that is known to be able to inhabit gut microbiome when there is dysbiosis.”
The study was sponsored by Synthetic Biologics. Dr. Kokai-Kun is an employee of the company.
SAN DIEGO – , results from a phase 2b study showed.
At an annual scientific meeting on infectious diseases, lead investigator John F. Kokai-Kun, PhD, said that the finding represents a paradigm shift in the use of intravenous beta-lactam antibiotics to prevent opportunistic infections. “We currently treat Clostridium difficile infection (CDI) with antibiotics, which attack the vegetative cells,” said Dr. Kokai-Kun, vice president of nonclinical affairs for Rockville, Md.–based Synthetic Biologics, which is developing ribaxamase. “Since C. diff. is primarily a toxin-mediated disease, certain products seem to neutralize the toxin. There’s also been work with probiotics and prebiotics to try to strengthen and repair the dysbiotic colon. Fecal replacement therapy has been shown to be fairly effective for treatment of recurrent C. diff. infection. What if we could simply block the initial insult that leads to this cascade? That’s the damage caused to the gut microbiome by the antibiotic that’s excreted to the intestine.”
That’s where ribaxamase comes in, he said at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society. Ribaxamase is an orally administered beta-lactamase designed to degrade penicillin and cephalosporins in the intestinal lumen. It’s formulated for release in the proximal small intestine and is expected to be given during or a short time after administration of IV beta-lactam antibiotics such as ceftriaxone. “This is expected to degrade the excess antibiotics that are excreted into the small intestine via the bile,” Dr. Kokai-Kun explained. “It’s designed to prevent disruption of the gut microbiome and thus protect from opportunistic GI infections like CDI.” Early-stage clinical studies demonstrated that ribaxamase was well tolerated and that it is not systemically absorbed, while phase 2 studies showed that ribaxamase degrades ceftriaxone in the intestine to below the level of detection while not affecting the pharmacokinetics of ceftriaxone in the plasma.
For the current study, 412 patients were enrolled at 84 multinational clinical sites. These patients were admitted to the hospital for treatment of a lower respiratory tract infection and were randomized 1:1 to receive ceftriaxone plus 150 mg ribaxamase or ceftriaxone plus placebo. Patients in both groups could also receive an oral macrolide at the discretion of the clinical investigator. The researchers also obtained fecal samples at screening, 72 hours post antibiotic treatment, and at the end of a 4-week follow-up visit, to determine colonization by opportunistic pathogens and to examine changes in the gut microbiome. Patients were monitored for 6 weeks for diarrhea and CDI. Diarrhea was defined as three or more loose or watery stools in a 24-hour period. “If that occurred, then we collected a sample, which was sent to the local lab to determine the presence of C. difficile toxins,” Dr. Kokai-Kun said.
The average age of study participants was 70 years, and about one-third in each arm received oral macrolides. The number of adverse events and serious adverse events were similar between active and placebo arms, and there was no trend associated with ribaxamase use. The lower respiratory tract infection cure rate to the ceftriaxone treatment was about 99% in both arms at 72 hours post treatment and at 2 weeks post treatment.
To analyze changes in the gut microbiome, the researchers conducted 16S rRNA sequencing of DNA extracted from fecal samples. In all, 652 samples were sequenced from 229 patients. Results from that analysis suggests that ribaxamase “appears to protect the gut microbiome from the onslaught of the ceftriaxone,” he said.
Ribaxamase reduced the incidence of new-onset CDI by 71%, compared with placebo (P = .045). “It apparently did this by protecting the integrity of the gut microbiome,” Dr. Kokai-Kun said. “There was also a significant reduction of new colonization by vancomycin-resistant enterococci at 72 hours and 4 weeks (P = .0001 and P = .0002, respectively) which is an opportunistic pathogen that is known to be able to inhabit gut microbiome when there is dysbiosis.”
The study was sponsored by Synthetic Biologics. Dr. Kokai-Kun is an employee of the company.
REPORTING FROM ID WEEK 2017
Key clinical point: Ribaxamase reduced new colonization with C. diff. and vancomycin-resistant enterococci.
Major finding: Ribaxamase reduced the incidence of new onset CDI by 71%, compared with placebo (P = 0.045).
Study details: A trial of 412 patients admitted to the hospital for treatment of a lower respiratory tract infection who were randomized to receive ceftriaxone plus 150 mg ribaxamase or ceftriaxone plus placebo.
Disclosures: The study was sponsored by Synthetic Biologics. Dr. Kokai-Kun is an employee of the company.
Iceland is making progress toward total eradication of HCV
SAN DIEGO, CA – A public health program in Iceland is on schedule to eliminate the potential for hepatitis C virus (HCV) transmission by curing all infected patients, according to a progress report presented at ID Week 2017.
“Our results are from a real-world setting, where the difficult-to-treat patients are actually prioritized,” explained Magnus Gottfredsson, MD, PhD, an infectious disease specialist affiliated with the National University Hospital, Reykjavik, Iceland.
“If we only scaled up treatment, we would not reach the goal of eliminating HCV infection. We needed something else,” Dr. Gottfredsson explained. This something else has been to reach out aggressively to those most likely to transmit disease. The multidisciplinary test-and-treat program engages physicians, nurses, and those providing psychosocial support across a variety of settings, including those involving addiction treatment, prison administration, and homeless outreach.
Of the 480 patients treated so far in the program, which offers treatment to all HCV-infected patients 16 years of age or older, Dr. Gottfredsson presented followup data on 322. All treatment is based on the direct acting antiviral (DAA) combination of sofosbuvir/ledipasvir (sof/ldv), usually given for 8 to 12 weeks. In selected cases, such as in HCV-infected patients with cirrhosis, patients also receive ribavirin. Gilead, the manufacturer of sof/ldv, has donated the therapy for the initial phase of the program.
Of the 322 patients treated, 298 patients completed therapy in accordance with the protocol and all were negative for HCV on polymerase chain reaction (PCR) testing at the end of treatment. When re-evaluated 12 weeks after treatment was completed, 6% were HCV positive. It is believed that most or all of these represented reinfection.
Of the 24 patients who did not complete therapy, 2 died and 19 were initially lost to follow-up. However, an intensive search was launched to locate the missing patients, and 17 of 19 were located. When evaluated with PCR, half were negative. As a result, the outcomes to data on an intention-to-treat analysis are 90% PCR negative, 8% still HCV positive and presumed reinfected, and 2% deceased or missing.
All of those who are reinfected have been or will be retreated.
“We prioritize those who are reinfected for retreatment because they are the individuals at greatest risk of transmitting infection,” Dr. Gottfredsson explained.
The rate of success is encouraging, because one third of the patients treated so far are active drug users. Of the 322 patients treated, 11% were living in halfway houses, 6% were homeless, and 5% were in prisons. One third of all DAA prescriptions in the TraP HepC program have been written by clinicians working in addiction medicine. The high rate of success was achieved despite the fact that 48% of HCV infections were genotype 3A virus, which is not the most responsive genotype to the DAAs offered.
Due to the presence of universal healthcare and universal HCV reporting, Iceland may be in an exceptional position to reduce HCV transmission to zero. Like many countries in northern Europe, the estimated prevalence of HCV is approximately 0.3%, which is 70% lower than that of the United States.
The World Health Organization has set a goal of a 90% reduction in the incidence of HCV by the year 2030, but Iceland is on track to eradicate HCV infection completely or nearly completely by the end of next year. If achieved, it will prevent transmission and produce 100% reduction in the incidence of HCV by 2019.
However, Dr. Gottfredsson acknowledged that treating all individuals currently infected with HCV in Iceland does not eliminate the threat of new cases and new transmissions. While he reported that procedures for routine screening of refugees and foreign workers are already in place, tourists and other visitors remain a potential source of new infections and a need for continued surveillance. Dr. Gottfredsson reports financial relationships with Astellas and Gilead.
SAN DIEGO, CA – A public health program in Iceland is on schedule to eliminate the potential for hepatitis C virus (HCV) transmission by curing all infected patients, according to a progress report presented at ID Week 2017.
“Our results are from a real-world setting, where the difficult-to-treat patients are actually prioritized,” explained Magnus Gottfredsson, MD, PhD, an infectious disease specialist affiliated with the National University Hospital, Reykjavik, Iceland.
“If we only scaled up treatment, we would not reach the goal of eliminating HCV infection. We needed something else,” Dr. Gottfredsson explained. This something else has been to reach out aggressively to those most likely to transmit disease. The multidisciplinary test-and-treat program engages physicians, nurses, and those providing psychosocial support across a variety of settings, including those involving addiction treatment, prison administration, and homeless outreach.
Of the 480 patients treated so far in the program, which offers treatment to all HCV-infected patients 16 years of age or older, Dr. Gottfredsson presented followup data on 322. All treatment is based on the direct acting antiviral (DAA) combination of sofosbuvir/ledipasvir (sof/ldv), usually given for 8 to 12 weeks. In selected cases, such as in HCV-infected patients with cirrhosis, patients also receive ribavirin. Gilead, the manufacturer of sof/ldv, has donated the therapy for the initial phase of the program.
Of the 322 patients treated, 298 patients completed therapy in accordance with the protocol and all were negative for HCV on polymerase chain reaction (PCR) testing at the end of treatment. When re-evaluated 12 weeks after treatment was completed, 6% were HCV positive. It is believed that most or all of these represented reinfection.
Of the 24 patients who did not complete therapy, 2 died and 19 were initially lost to follow-up. However, an intensive search was launched to locate the missing patients, and 17 of 19 were located. When evaluated with PCR, half were negative. As a result, the outcomes to data on an intention-to-treat analysis are 90% PCR negative, 8% still HCV positive and presumed reinfected, and 2% deceased or missing.
All of those who are reinfected have been or will be retreated.
“We prioritize those who are reinfected for retreatment because they are the individuals at greatest risk of transmitting infection,” Dr. Gottfredsson explained.
The rate of success is encouraging, because one third of the patients treated so far are active drug users. Of the 322 patients treated, 11% were living in halfway houses, 6% were homeless, and 5% were in prisons. One third of all DAA prescriptions in the TraP HepC program have been written by clinicians working in addiction medicine. The high rate of success was achieved despite the fact that 48% of HCV infections were genotype 3A virus, which is not the most responsive genotype to the DAAs offered.
Due to the presence of universal healthcare and universal HCV reporting, Iceland may be in an exceptional position to reduce HCV transmission to zero. Like many countries in northern Europe, the estimated prevalence of HCV is approximately 0.3%, which is 70% lower than that of the United States.
The World Health Organization has set a goal of a 90% reduction in the incidence of HCV by the year 2030, but Iceland is on track to eradicate HCV infection completely or nearly completely by the end of next year. If achieved, it will prevent transmission and produce 100% reduction in the incidence of HCV by 2019.
However, Dr. Gottfredsson acknowledged that treating all individuals currently infected with HCV in Iceland does not eliminate the threat of new cases and new transmissions. While he reported that procedures for routine screening of refugees and foreign workers are already in place, tourists and other visitors remain a potential source of new infections and a need for continued surveillance. Dr. Gottfredsson reports financial relationships with Astellas and Gilead.
SAN DIEGO, CA – A public health program in Iceland is on schedule to eliminate the potential for hepatitis C virus (HCV) transmission by curing all infected patients, according to a progress report presented at ID Week 2017.
“Our results are from a real-world setting, where the difficult-to-treat patients are actually prioritized,” explained Magnus Gottfredsson, MD, PhD, an infectious disease specialist affiliated with the National University Hospital, Reykjavik, Iceland.
“If we only scaled up treatment, we would not reach the goal of eliminating HCV infection. We needed something else,” Dr. Gottfredsson explained. This something else has been to reach out aggressively to those most likely to transmit disease. The multidisciplinary test-and-treat program engages physicians, nurses, and those providing psychosocial support across a variety of settings, including those involving addiction treatment, prison administration, and homeless outreach.
Of the 480 patients treated so far in the program, which offers treatment to all HCV-infected patients 16 years of age or older, Dr. Gottfredsson presented followup data on 322. All treatment is based on the direct acting antiviral (DAA) combination of sofosbuvir/ledipasvir (sof/ldv), usually given for 8 to 12 weeks. In selected cases, such as in HCV-infected patients with cirrhosis, patients also receive ribavirin. Gilead, the manufacturer of sof/ldv, has donated the therapy for the initial phase of the program.
Of the 322 patients treated, 298 patients completed therapy in accordance with the protocol and all were negative for HCV on polymerase chain reaction (PCR) testing at the end of treatment. When re-evaluated 12 weeks after treatment was completed, 6% were HCV positive. It is believed that most or all of these represented reinfection.
Of the 24 patients who did not complete therapy, 2 died and 19 were initially lost to follow-up. However, an intensive search was launched to locate the missing patients, and 17 of 19 were located. When evaluated with PCR, half were negative. As a result, the outcomes to data on an intention-to-treat analysis are 90% PCR negative, 8% still HCV positive and presumed reinfected, and 2% deceased or missing.
All of those who are reinfected have been or will be retreated.
“We prioritize those who are reinfected for retreatment because they are the individuals at greatest risk of transmitting infection,” Dr. Gottfredsson explained.
The rate of success is encouraging, because one third of the patients treated so far are active drug users. Of the 322 patients treated, 11% were living in halfway houses, 6% were homeless, and 5% were in prisons. One third of all DAA prescriptions in the TraP HepC program have been written by clinicians working in addiction medicine. The high rate of success was achieved despite the fact that 48% of HCV infections were genotype 3A virus, which is not the most responsive genotype to the DAAs offered.
Due to the presence of universal healthcare and universal HCV reporting, Iceland may be in an exceptional position to reduce HCV transmission to zero. Like many countries in northern Europe, the estimated prevalence of HCV is approximately 0.3%, which is 70% lower than that of the United States.
The World Health Organization has set a goal of a 90% reduction in the incidence of HCV by the year 2030, but Iceland is on track to eradicate HCV infection completely or nearly completely by the end of next year. If achieved, it will prevent transmission and produce 100% reduction in the incidence of HCV by 2019.
However, Dr. Gottfredsson acknowledged that treating all individuals currently infected with HCV in Iceland does not eliminate the threat of new cases and new transmissions. While he reported that procedures for routine screening of refugees and foreign workers are already in place, tourists and other visitors remain a potential source of new infections and a need for continued surveillance. Dr. Gottfredsson reports financial relationships with Astellas and Gilead.
ID WEEK 2017
Key clinical point:
Major finding: Just 20 months into the program, there has been a nearly 50% reduction in HCV infections, and the plan is to reach all patients by end of 2018.
Data source: Update on national public health initiative.
Disclosures: Dr. Gottfredsson reports financial relationships with Astellas and Gilead.
Household MRSA contamination predicted human recolonization
SAN DIEGO – Patients who were successfully treated for methicillin-resistant Staphylococcus aureus infections were about four times more likely to become recolonized if their homes contained MRSA, according to the results of a longitudinal household study.
“Many of these homes were contaminated with a classic community strain,” Meghan Frost Davis, DVM, PhD, MPH, said during an oral presentation at an annual meeting on infectious disease. “We need to think about interventions in the home environment to improve our ability to achieve successful decolonization.”
Importantly, Dr. Davis and her associates recently published another study in which biocidal disinfectants failed to eliminate MRSA from homes and appeared to increase the risk of multi-drug resistance (Appl Environ Microbiol. online 22 September 2017, doi: 10.1128/AEM.01369-17). Her team is testing MRSA isolates for resistance to disinfectants and hopes to have more information in about a year, she said. Until then, Dr. Davis suggests advising patients with MRSA to clean sheets and pillowcases frequently.
S. aureus can survive in the environment for long periods. In one case, a MRSA strain tied to an outbreak was cultured from a dry mop that had been locked in a closet for 79 months, Dr. Davis said. “This is concerning because the home is a place that receives bacteria from us,” she said. “A person who was originally colonized or infected with MRSA may clear naturally or through treatment, but the environment may become a reservoir for recolonization and infection.”
To better understand the role of this reservoir, she and her associates recruited 88 index outpatients with MRSA skin and soft tissue infections who were part of a randomized trial of MRSA decolonization strategies. At baseline and 3 months later, the researchers sampled multiple sites in each patient’s home and all household pets. Patients and household members also swabbed themselves in multiple body sites every 2 weeks for up to 3 months. Swabs were cultured in enrichment broth, and positive results were confirmed by PCR (Infect Control Hosp Epidemiol. 2016 Oct;37[10]:1226-33. doi: 10.1017/ice.2016.138. Epub 2016 Jul 28).
Even after accounting for potential confounders, household contamination with MRSA was associated with about a three- to five-fold increase in the odds of human colonization, which was statistically significant. Seventy percent of households had at least one pet, but only 10% had a pet colonized with MRSA. Having such a pet increased the risk of human carriage slightly, but not significantly. However, having more than one pet did predict human colonization, Dr. Davis said. Even if pets aren’t colonized, they still can carry MRSA on “the petting zone” – the top of the head and back, she explained. Thus, pets can serve as reservoirs for MRSA without being colonized.
In all, 53 index patients had at least two consecutive negative cultures and thus were considered decolonized. However, 43% of these individuals were subsequently re-colonized, and those whose homes contained MRSA at baseline were about 4.3 times more likely to become recolonized than those whose households cultured negative (hazard ratio, 4.3; 95% CI, 1.2-16; P less than .03).
A total of six patients were persistently colonized with MRSA, and 62% of contaminated homes tested positive for MRSA Staph protein A (spa) type t008, a common community-onset strain. Living in one of these households significantly increased the chances of persistent colonization (odds ratio, 12.7; 95% CI, 1.33-122; P less than .03).
Pets testing positive for MRSA always came from homes that also tested positive, so these factors couldn’t be disentangled, Dr. Davis said. Repository surfaces in homes – such as the top of a refrigerator – were just as likely to be contaminated with MRSA as high-touch surfaces. However, pillowcases often were most contaminated of all. “If I can give you one take-home message, when you treat people with MRSA, you may want to tell them to clean their sheets and pillowcases a lot.”
Dr. Davis and her associates had no disclosures.
SAN DIEGO – Patients who were successfully treated for methicillin-resistant Staphylococcus aureus infections were about four times more likely to become recolonized if their homes contained MRSA, according to the results of a longitudinal household study.
“Many of these homes were contaminated with a classic community strain,” Meghan Frost Davis, DVM, PhD, MPH, said during an oral presentation at an annual meeting on infectious disease. “We need to think about interventions in the home environment to improve our ability to achieve successful decolonization.”
Importantly, Dr. Davis and her associates recently published another study in which biocidal disinfectants failed to eliminate MRSA from homes and appeared to increase the risk of multi-drug resistance (Appl Environ Microbiol. online 22 September 2017, doi: 10.1128/AEM.01369-17). Her team is testing MRSA isolates for resistance to disinfectants and hopes to have more information in about a year, she said. Until then, Dr. Davis suggests advising patients with MRSA to clean sheets and pillowcases frequently.
S. aureus can survive in the environment for long periods. In one case, a MRSA strain tied to an outbreak was cultured from a dry mop that had been locked in a closet for 79 months, Dr. Davis said. “This is concerning because the home is a place that receives bacteria from us,” she said. “A person who was originally colonized or infected with MRSA may clear naturally or through treatment, but the environment may become a reservoir for recolonization and infection.”
To better understand the role of this reservoir, she and her associates recruited 88 index outpatients with MRSA skin and soft tissue infections who were part of a randomized trial of MRSA decolonization strategies. At baseline and 3 months later, the researchers sampled multiple sites in each patient’s home and all household pets. Patients and household members also swabbed themselves in multiple body sites every 2 weeks for up to 3 months. Swabs were cultured in enrichment broth, and positive results were confirmed by PCR (Infect Control Hosp Epidemiol. 2016 Oct;37[10]:1226-33. doi: 10.1017/ice.2016.138. Epub 2016 Jul 28).
Even after accounting for potential confounders, household contamination with MRSA was associated with about a three- to five-fold increase in the odds of human colonization, which was statistically significant. Seventy percent of households had at least one pet, but only 10% had a pet colonized with MRSA. Having such a pet increased the risk of human carriage slightly, but not significantly. However, having more than one pet did predict human colonization, Dr. Davis said. Even if pets aren’t colonized, they still can carry MRSA on “the petting zone” – the top of the head and back, she explained. Thus, pets can serve as reservoirs for MRSA without being colonized.
In all, 53 index patients had at least two consecutive negative cultures and thus were considered decolonized. However, 43% of these individuals were subsequently re-colonized, and those whose homes contained MRSA at baseline were about 4.3 times more likely to become recolonized than those whose households cultured negative (hazard ratio, 4.3; 95% CI, 1.2-16; P less than .03).
A total of six patients were persistently colonized with MRSA, and 62% of contaminated homes tested positive for MRSA Staph protein A (spa) type t008, a common community-onset strain. Living in one of these households significantly increased the chances of persistent colonization (odds ratio, 12.7; 95% CI, 1.33-122; P less than .03).
Pets testing positive for MRSA always came from homes that also tested positive, so these factors couldn’t be disentangled, Dr. Davis said. Repository surfaces in homes – such as the top of a refrigerator – were just as likely to be contaminated with MRSA as high-touch surfaces. However, pillowcases often were most contaminated of all. “If I can give you one take-home message, when you treat people with MRSA, you may want to tell them to clean their sheets and pillowcases a lot.”
Dr. Davis and her associates had no disclosures.
SAN DIEGO – Patients who were successfully treated for methicillin-resistant Staphylococcus aureus infections were about four times more likely to become recolonized if their homes contained MRSA, according to the results of a longitudinal household study.
“Many of these homes were contaminated with a classic community strain,” Meghan Frost Davis, DVM, PhD, MPH, said during an oral presentation at an annual meeting on infectious disease. “We need to think about interventions in the home environment to improve our ability to achieve successful decolonization.”
Importantly, Dr. Davis and her associates recently published another study in which biocidal disinfectants failed to eliminate MRSA from homes and appeared to increase the risk of multi-drug resistance (Appl Environ Microbiol. online 22 September 2017, doi: 10.1128/AEM.01369-17). Her team is testing MRSA isolates for resistance to disinfectants and hopes to have more information in about a year, she said. Until then, Dr. Davis suggests advising patients with MRSA to clean sheets and pillowcases frequently.
S. aureus can survive in the environment for long periods. In one case, a MRSA strain tied to an outbreak was cultured from a dry mop that had been locked in a closet for 79 months, Dr. Davis said. “This is concerning because the home is a place that receives bacteria from us,” she said. “A person who was originally colonized or infected with MRSA may clear naturally or through treatment, but the environment may become a reservoir for recolonization and infection.”
To better understand the role of this reservoir, she and her associates recruited 88 index outpatients with MRSA skin and soft tissue infections who were part of a randomized trial of MRSA decolonization strategies. At baseline and 3 months later, the researchers sampled multiple sites in each patient’s home and all household pets. Patients and household members also swabbed themselves in multiple body sites every 2 weeks for up to 3 months. Swabs were cultured in enrichment broth, and positive results were confirmed by PCR (Infect Control Hosp Epidemiol. 2016 Oct;37[10]:1226-33. doi: 10.1017/ice.2016.138. Epub 2016 Jul 28).
Even after accounting for potential confounders, household contamination with MRSA was associated with about a three- to five-fold increase in the odds of human colonization, which was statistically significant. Seventy percent of households had at least one pet, but only 10% had a pet colonized with MRSA. Having such a pet increased the risk of human carriage slightly, but not significantly. However, having more than one pet did predict human colonization, Dr. Davis said. Even if pets aren’t colonized, they still can carry MRSA on “the petting zone” – the top of the head and back, she explained. Thus, pets can serve as reservoirs for MRSA without being colonized.
In all, 53 index patients had at least two consecutive negative cultures and thus were considered decolonized. However, 43% of these individuals were subsequently re-colonized, and those whose homes contained MRSA at baseline were about 4.3 times more likely to become recolonized than those whose households cultured negative (hazard ratio, 4.3; 95% CI, 1.2-16; P less than .03).
A total of six patients were persistently colonized with MRSA, and 62% of contaminated homes tested positive for MRSA Staph protein A (spa) type t008, a common community-onset strain. Living in one of these households significantly increased the chances of persistent colonization (odds ratio, 12.7; 95% CI, 1.33-122; P less than .03).
Pets testing positive for MRSA always came from homes that also tested positive, so these factors couldn’t be disentangled, Dr. Davis said. Repository surfaces in homes – such as the top of a refrigerator – were just as likely to be contaminated with MRSA as high-touch surfaces. However, pillowcases often were most contaminated of all. “If I can give you one take-home message, when you treat people with MRSA, you may want to tell them to clean their sheets and pillowcases a lot.”
Dr. Davis and her associates had no disclosures.
IDWEEK 2017
Key clinical point: Patients who were successfully decolonized of MRSA were significantly more likely to become recolonized if their homes were contaminated with MRSA.
Major finding: The risk of recolonization was about four-fold higher if a home was contaminated at baseline (hazard ratio, 4.3; 95% CI, 1.2-16).
Data source: A nested household study that enrolled 88 index patients with MRSA skin and soft tissue infections.
Disclosures: Dr. Davis and her associates had no disclosures.
Study IDs risk predictors of PrEP use in MSM
SAN DIEGO – Recent sexual risk behavior and partnership type may be important predictors of pre-exposure prophylaxis in men who have sex with men, results from a 48-week study suggest.
“We know from other studies including iPrEX, the Partners PrEP, and the Demo project that individuals who report higher risk behaviors are more likely to be adherent to pre-exposure prophylaxis (PrEP),” lead study author Jill Blumenthal, MD, said in an interview in advance of an annual scientific meeting on infectious diseases.
As part of a PrEP California Collaborative Treatment Group demonstration study of 398 HIV-negative at-risk men who have sex with men and transgender women, Dr. Blumenthal, of the Antiviral Research Center at the University of California, San Diego, and her associates estimated their HIV risk score at baseline and week 48. Their score was estimated as the probability of seroconversion over the next year based on number of condomless anal sex acts with HIV+/unknown partners in the last month and any sexually transmitted infection diagnosed at study visit. The researchers categorized HIV risk score as low (less than 0.12), moderate (0.12-0.59) and high (greater than 0.59) risk based on population seroconversion probabilities. They assigned partnership as no/single HIV- partner, single HIV+ partner, or multiple partners of any serostatus in the past 3 months. They estimated PrEP adherence by intracellular tenofovir-diphosphate (TFV-DP) levels as a continuous variable at week 48.
Of 313 study participants who completed week 48, the researchers observed no significant change in HIV risk category from baseline to week 48 (low: 44% to 42%; moderate: 27% to 24%; high: 28% to 34%; P=0.25). However, there was a significant change in partnership type, with the proportion of those with no or single HIV- partnerships increasing from 1% to 9% (P less than 0.001). Univariate analysis revealed that moderate and high risk groups had higher TFV-DP levels, compared with the low risk group at week 48 (P = 0.018). Participants with no/single HIV- partner had significantly lower TFV-DP levels, compared with those who had one HIV+ partner or multiple partners (P = 0.007). On multivariable linear regression, only low risk partnerships remained significant where no/single HIV- partnerships were associated with lower TFV-DP levels (P = 0.014).
“Although more individuals in our study reported having either no or a single HIV-negative partners by the end of the study, there was no decrease in risk behavior based on reported condomless anal sex acts and laboratory-confirmed STIs over time,” Dr. Blumenthal said. “However, those risk behaviors did not increase either, arguing against risk compensation. Individuals with higher HIV risk behaviors and in riskier partnerships (those with either a single HIV+ or multiple partners) had higher TFV-DP levels at week 48 suggesting a maintained, strong motivation for PrEP adherence.”
She acknowledged certain limitations of the study, including the fact that the risk behavior score used in the analysis has not been validated in prospective studies of HIV incidence. “In addition, participants in the study were not allowed to start and stop PrEP, so less risky individuals may have remained in the study in the event they wanted to restart PrEP,” she said. Dr. Blumenthal disclosed that she is a Gilead Educational Grant recipient and that the study drug was provided by Gilead.
SAN DIEGO – Recent sexual risk behavior and partnership type may be important predictors of pre-exposure prophylaxis in men who have sex with men, results from a 48-week study suggest.
“We know from other studies including iPrEX, the Partners PrEP, and the Demo project that individuals who report higher risk behaviors are more likely to be adherent to pre-exposure prophylaxis (PrEP),” lead study author Jill Blumenthal, MD, said in an interview in advance of an annual scientific meeting on infectious diseases.
As part of a PrEP California Collaborative Treatment Group demonstration study of 398 HIV-negative at-risk men who have sex with men and transgender women, Dr. Blumenthal, of the Antiviral Research Center at the University of California, San Diego, and her associates estimated their HIV risk score at baseline and week 48. Their score was estimated as the probability of seroconversion over the next year based on number of condomless anal sex acts with HIV+/unknown partners in the last month and any sexually transmitted infection diagnosed at study visit. The researchers categorized HIV risk score as low (less than 0.12), moderate (0.12-0.59) and high (greater than 0.59) risk based on population seroconversion probabilities. They assigned partnership as no/single HIV- partner, single HIV+ partner, or multiple partners of any serostatus in the past 3 months. They estimated PrEP adherence by intracellular tenofovir-diphosphate (TFV-DP) levels as a continuous variable at week 48.
Of 313 study participants who completed week 48, the researchers observed no significant change in HIV risk category from baseline to week 48 (low: 44% to 42%; moderate: 27% to 24%; high: 28% to 34%; P=0.25). However, there was a significant change in partnership type, with the proportion of those with no or single HIV- partnerships increasing from 1% to 9% (P less than 0.001). Univariate analysis revealed that moderate and high risk groups had higher TFV-DP levels, compared with the low risk group at week 48 (P = 0.018). Participants with no/single HIV- partner had significantly lower TFV-DP levels, compared with those who had one HIV+ partner or multiple partners (P = 0.007). On multivariable linear regression, only low risk partnerships remained significant where no/single HIV- partnerships were associated with lower TFV-DP levels (P = 0.014).
“Although more individuals in our study reported having either no or a single HIV-negative partners by the end of the study, there was no decrease in risk behavior based on reported condomless anal sex acts and laboratory-confirmed STIs over time,” Dr. Blumenthal said. “However, those risk behaviors did not increase either, arguing against risk compensation. Individuals with higher HIV risk behaviors and in riskier partnerships (those with either a single HIV+ or multiple partners) had higher TFV-DP levels at week 48 suggesting a maintained, strong motivation for PrEP adherence.”
She acknowledged certain limitations of the study, including the fact that the risk behavior score used in the analysis has not been validated in prospective studies of HIV incidence. “In addition, participants in the study were not allowed to start and stop PrEP, so less risky individuals may have remained in the study in the event they wanted to restart PrEP,” she said. Dr. Blumenthal disclosed that she is a Gilead Educational Grant recipient and that the study drug was provided by Gilead.
SAN DIEGO – Recent sexual risk behavior and partnership type may be important predictors of pre-exposure prophylaxis in men who have sex with men, results from a 48-week study suggest.
“We know from other studies including iPrEX, the Partners PrEP, and the Demo project that individuals who report higher risk behaviors are more likely to be adherent to pre-exposure prophylaxis (PrEP),” lead study author Jill Blumenthal, MD, said in an interview in advance of an annual scientific meeting on infectious diseases.
As part of a PrEP California Collaborative Treatment Group demonstration study of 398 HIV-negative at-risk men who have sex with men and transgender women, Dr. Blumenthal, of the Antiviral Research Center at the University of California, San Diego, and her associates estimated their HIV risk score at baseline and week 48. Their score was estimated as the probability of seroconversion over the next year based on number of condomless anal sex acts with HIV+/unknown partners in the last month and any sexually transmitted infection diagnosed at study visit. The researchers categorized HIV risk score as low (less than 0.12), moderate (0.12-0.59) and high (greater than 0.59) risk based on population seroconversion probabilities. They assigned partnership as no/single HIV- partner, single HIV+ partner, or multiple partners of any serostatus in the past 3 months. They estimated PrEP adherence by intracellular tenofovir-diphosphate (TFV-DP) levels as a continuous variable at week 48.
Of 313 study participants who completed week 48, the researchers observed no significant change in HIV risk category from baseline to week 48 (low: 44% to 42%; moderate: 27% to 24%; high: 28% to 34%; P=0.25). However, there was a significant change in partnership type, with the proportion of those with no or single HIV- partnerships increasing from 1% to 9% (P less than 0.001). Univariate analysis revealed that moderate and high risk groups had higher TFV-DP levels, compared with the low risk group at week 48 (P = 0.018). Participants with no/single HIV- partner had significantly lower TFV-DP levels, compared with those who had one HIV+ partner or multiple partners (P = 0.007). On multivariable linear regression, only low risk partnerships remained significant where no/single HIV- partnerships were associated with lower TFV-DP levels (P = 0.014).
“Although more individuals in our study reported having either no or a single HIV-negative partners by the end of the study, there was no decrease in risk behavior based on reported condomless anal sex acts and laboratory-confirmed STIs over time,” Dr. Blumenthal said. “However, those risk behaviors did not increase either, arguing against risk compensation. Individuals with higher HIV risk behaviors and in riskier partnerships (those with either a single HIV+ or multiple partners) had higher TFV-DP levels at week 48 suggesting a maintained, strong motivation for PrEP adherence.”
She acknowledged certain limitations of the study, including the fact that the risk behavior score used in the analysis has not been validated in prospective studies of HIV incidence. “In addition, participants in the study were not allowed to start and stop PrEP, so less risky individuals may have remained in the study in the event they wanted to restart PrEP,” she said. Dr. Blumenthal disclosed that she is a Gilead Educational Grant recipient and that the study drug was provided by Gilead.
ID WEEK 2017
Key clinical point: Recent HIV risk behavior and partnership type predict pre-exposure prophylaxis adherence in men who have sex with men.
Major finding: After 48 weeks, the proportion of those with no or single HIV- partnerships increased from 1% to 9% (P less than 0.001).
Study details: A demonstration study of 398 HIV-negative at-risk men who have sex with men and transgender women.
Disclosures: Dr. Blumenthal disclosed that she is a Gilead Educational Grant recipient and that the study drug was provided by Gilead.
Focal cultures, PCR upped Kingella detection in pediatric hematogenous osteomyelitis
SAN DIEGO – Early focal cultures and strategic use of polymerase chain reaction (PCR) testing helped a hospital detect Kingella kingae seven times more often in a study of young children with acute non-complex hematogenous osteomyelitis, Rachel Quick, MSN, CNS, said at an annual meeting on infectious diseases.
Kingella kingae turned out to be the leading culprit in these cases, although the new approach also enhanced detection of Staphylococcus aureus and other bacteria, said Ms. Quick of Seton Healthcare Family in Austin, Texas. Children also transitioned to oral antibiotics a median of 22 days sooner and needed peripherally inserted central catheters (PICC) two-thirds less often after the guideline was implemented, she said during her oral presentation.
After implementing the guideline, Ms. Quick and her associates compared 25 children treated beforehand with 24 children treated afterward. Patients were 6 months to 5 years old, had physical signs and symptoms of acute hematogenous osteomyelitis or septic joint, and had been symptomatic for less than 14 days. The study was conducted between 2009 and 2016.
Kingella kingae was identified in one patient (4%) from the baseline cohort and in seven patients (29%) after the guideline was rolled out (P = .02), Ms. Quick said. Kingella was cultured from focal samples only, not from blood. Detection of methicillin-sensitive Staphylococcus aureus (MSSA) jumped from 8% to 17%, while cases with no detectable pathogen dropped from 80% to 46%. Lengths of stay and readmission rates did not change significantly.
Taken together, the findings show how early focal cultures and PCR can facilitate targeted therapy in acute pediatric bone and joint infections, prevent unnecessary antibiotic use, and expedite a targeted transition to oral antibiotics, said Ms. Quick. “We recognize that we have a small sample and that these are not complicated cases,” she said. “Our findings do not suggest it’s more important to look for Kingella than Staphylococcus aureus, but that Kingella should be up there in the ranks of what we’re looking for.”
The investigators reported having no conflicts of interest.
SAN DIEGO – Early focal cultures and strategic use of polymerase chain reaction (PCR) testing helped a hospital detect Kingella kingae seven times more often in a study of young children with acute non-complex hematogenous osteomyelitis, Rachel Quick, MSN, CNS, said at an annual meeting on infectious diseases.
Kingella kingae turned out to be the leading culprit in these cases, although the new approach also enhanced detection of Staphylococcus aureus and other bacteria, said Ms. Quick of Seton Healthcare Family in Austin, Texas. Children also transitioned to oral antibiotics a median of 22 days sooner and needed peripherally inserted central catheters (PICC) two-thirds less often after the guideline was implemented, she said during her oral presentation.
After implementing the guideline, Ms. Quick and her associates compared 25 children treated beforehand with 24 children treated afterward. Patients were 6 months to 5 years old, had physical signs and symptoms of acute hematogenous osteomyelitis or septic joint, and had been symptomatic for less than 14 days. The study was conducted between 2009 and 2016.
Kingella kingae was identified in one patient (4%) from the baseline cohort and in seven patients (29%) after the guideline was rolled out (P = .02), Ms. Quick said. Kingella was cultured from focal samples only, not from blood. Detection of methicillin-sensitive Staphylococcus aureus (MSSA) jumped from 8% to 17%, while cases with no detectable pathogen dropped from 80% to 46%. Lengths of stay and readmission rates did not change significantly.
Taken together, the findings show how early focal cultures and PCR can facilitate targeted therapy in acute pediatric bone and joint infections, prevent unnecessary antibiotic use, and expedite a targeted transition to oral antibiotics, said Ms. Quick. “We recognize that we have a small sample and that these are not complicated cases,” she said. “Our findings do not suggest it’s more important to look for Kingella than Staphylococcus aureus, but that Kingella should be up there in the ranks of what we’re looking for.”
The investigators reported having no conflicts of interest.
SAN DIEGO – Early focal cultures and strategic use of polymerase chain reaction (PCR) testing helped a hospital detect Kingella kingae seven times more often in a study of young children with acute non-complex hematogenous osteomyelitis, Rachel Quick, MSN, CNS, said at an annual meeting on infectious diseases.
Kingella kingae turned out to be the leading culprit in these cases, although the new approach also enhanced detection of Staphylococcus aureus and other bacteria, said Ms. Quick of Seton Healthcare Family in Austin, Texas. Children also transitioned to oral antibiotics a median of 22 days sooner and needed peripherally inserted central catheters (PICC) two-thirds less often after the guideline was implemented, she said during her oral presentation.
After implementing the guideline, Ms. Quick and her associates compared 25 children treated beforehand with 24 children treated afterward. Patients were 6 months to 5 years old, had physical signs and symptoms of acute hematogenous osteomyelitis or septic joint, and had been symptomatic for less than 14 days. The study was conducted between 2009 and 2016.
Kingella kingae was identified in one patient (4%) from the baseline cohort and in seven patients (29%) after the guideline was rolled out (P = .02), Ms. Quick said. Kingella was cultured from focal samples only, not from blood. Detection of methicillin-sensitive Staphylococcus aureus (MSSA) jumped from 8% to 17%, while cases with no detectable pathogen dropped from 80% to 46%. Lengths of stay and readmission rates did not change significantly.
Taken together, the findings show how early focal cultures and PCR can facilitate targeted therapy in acute pediatric bone and joint infections, prevent unnecessary antibiotic use, and expedite a targeted transition to oral antibiotics, said Ms. Quick. “We recognize that we have a small sample and that these are not complicated cases,” she said. “Our findings do not suggest it’s more important to look for Kingella than Staphylococcus aureus, but that Kingella should be up there in the ranks of what we’re looking for.”
The investigators reported having no conflicts of interest.
IDWEEK 2017
Key clinical point: Early focal cultures and strategic use of polymerase chain reaction (PCR) enhanced detection of Kingella kingae and other bacteria in young children with acute non-complex hematogenous osteomyelitis
Major finding: Detection of Kingella surged from 4% to 29%.
Data source: A retrospective cohort study of 49 children with non-complex acute hematogenous osteomyelitis or septic arthritis.
Disclosures: The investigators reported having no conflicts of interest.
Public health intervention helps stem tuberculosis transmission
SAN DIEGO – Using an on-site multi-disciplinary team to approach patients who are unwilling to receive tuberculosis treatment can improve patient cooperation, according to a case study presented ID Week 2017, an infectious disease meeting.
Such public health interventions may be able to improve disease control and interrupt the transmission cycle among patients who are not adhering to treatment, according to Aisha Haynie, MD, MPA.
“We started the patient on treatment and she actually decided to move into a motel,” said Dr. Haynie. “After that, she moved back into the family home and said she wasn’t having any contact [with residents], which we didn’t really believe.”
While the patient did reluctantly give Dr. Haynie and her team a list of five family members to test, the patient told Dr. Haynie that she and her team were not allowed into the patient’s home.
When the five members were tested, the new patients showed similar signs of reluctance and mistrust of the health system.
“The family members came to our clinic and two of them were TB positive,” recounted Dr. Haynie. “So they came back, but while they were sitting in the waiting room, they signed papers and they left.”
Despite continuous attempts to reach the family and address the growing concern from health professionals of the danger of TB transmission to other members of the family, patients continue not to adhere to procedures beyond pharmaceutical intervention.
In an attempt to directly contact the patient’s family, Dr. Haynie lead a team consisting of a local health authority physician, a TB nurse practitioner, a TB contact analyst, a nurse case manager, a county attorney, and an interpreter for unscheduled visits to family members individually.
“We had specific requests [including] keeping appointments, getting labs, and we added a deadline,” said Dr. Haynie, Chief of Disease Control and Medical Epidemiology for the Harris County Public Health & Environmental Services. “By the next Friday [we told them that] we were filing court papers with or without the information and we [would] be contacting child protective services as well.”
Following the intervention, the patient and her family adhered to testing procedures. This revealed an infant with active TB and 8 other family members with TB Infection. Isolation breaches were also discovered. Most importantly, the TB transmission cycle was interrupted, according to Dr. Haynie.
A key aspect of the team’s successful approach was to address cultural and economic barriers that hindered successful interaction with the family, TB misconceptions corrected in order for a trusting relationship to develop.
The investigators developed this intervention in Harris County, Tx, which at 4.3 million residents is the 3rd most populous U.S. county, and has reported a TB case rate of 7.6 cases per 100,000, which is approximately double that of the U.S. average, according to Dr. Haynie. Of those cases in Harris County, 73% are foreign-born, compared with the average rate of 59% in Texas.
Dr. Haynie and fellow investigators asserted part of the reason patients were so reluctant to receive treatment from the Harris County Public Health department was a combination of mistrust in the system and a number of false ideas patients have regarding TB, a sign of further educational tools being needed.
Since the first use of the intervention, Dr. Haynie and her team have implemented this approach with other non-adherent patients with relative success.
“This is something that we now do and we have not been back to court [to enforce compliance] since,” said Dr. Haynie.
[email protected]
On Twitter @eaztweets
SAN DIEGO – Using an on-site multi-disciplinary team to approach patients who are unwilling to receive tuberculosis treatment can improve patient cooperation, according to a case study presented ID Week 2017, an infectious disease meeting.
Such public health interventions may be able to improve disease control and interrupt the transmission cycle among patients who are not adhering to treatment, according to Aisha Haynie, MD, MPA.
“We started the patient on treatment and she actually decided to move into a motel,” said Dr. Haynie. “After that, she moved back into the family home and said she wasn’t having any contact [with residents], which we didn’t really believe.”
While the patient did reluctantly give Dr. Haynie and her team a list of five family members to test, the patient told Dr. Haynie that she and her team were not allowed into the patient’s home.
When the five members were tested, the new patients showed similar signs of reluctance and mistrust of the health system.
“The family members came to our clinic and two of them were TB positive,” recounted Dr. Haynie. “So they came back, but while they were sitting in the waiting room, they signed papers and they left.”
Despite continuous attempts to reach the family and address the growing concern from health professionals of the danger of TB transmission to other members of the family, patients continue not to adhere to procedures beyond pharmaceutical intervention.
In an attempt to directly contact the patient’s family, Dr. Haynie lead a team consisting of a local health authority physician, a TB nurse practitioner, a TB contact analyst, a nurse case manager, a county attorney, and an interpreter for unscheduled visits to family members individually.
“We had specific requests [including] keeping appointments, getting labs, and we added a deadline,” said Dr. Haynie, Chief of Disease Control and Medical Epidemiology for the Harris County Public Health & Environmental Services. “By the next Friday [we told them that] we were filing court papers with or without the information and we [would] be contacting child protective services as well.”
Following the intervention, the patient and her family adhered to testing procedures. This revealed an infant with active TB and 8 other family members with TB Infection. Isolation breaches were also discovered. Most importantly, the TB transmission cycle was interrupted, according to Dr. Haynie.
A key aspect of the team’s successful approach was to address cultural and economic barriers that hindered successful interaction with the family, TB misconceptions corrected in order for a trusting relationship to develop.
The investigators developed this intervention in Harris County, Tx, which at 4.3 million residents is the 3rd most populous U.S. county, and has reported a TB case rate of 7.6 cases per 100,000, which is approximately double that of the U.S. average, according to Dr. Haynie. Of those cases in Harris County, 73% are foreign-born, compared with the average rate of 59% in Texas.
Dr. Haynie and fellow investigators asserted part of the reason patients were so reluctant to receive treatment from the Harris County Public Health department was a combination of mistrust in the system and a number of false ideas patients have regarding TB, a sign of further educational tools being needed.
Since the first use of the intervention, Dr. Haynie and her team have implemented this approach with other non-adherent patients with relative success.
“This is something that we now do and we have not been back to court [to enforce compliance] since,” said Dr. Haynie.
[email protected]
On Twitter @eaztweets
SAN DIEGO – Using an on-site multi-disciplinary team to approach patients who are unwilling to receive tuberculosis treatment can improve patient cooperation, according to a case study presented ID Week 2017, an infectious disease meeting.
Such public health interventions may be able to improve disease control and interrupt the transmission cycle among patients who are not adhering to treatment, according to Aisha Haynie, MD, MPA.
“We started the patient on treatment and she actually decided to move into a motel,” said Dr. Haynie. “After that, she moved back into the family home and said she wasn’t having any contact [with residents], which we didn’t really believe.”
While the patient did reluctantly give Dr. Haynie and her team a list of five family members to test, the patient told Dr. Haynie that she and her team were not allowed into the patient’s home.
When the five members were tested, the new patients showed similar signs of reluctance and mistrust of the health system.
“The family members came to our clinic and two of them were TB positive,” recounted Dr. Haynie. “So they came back, but while they were sitting in the waiting room, they signed papers and they left.”
Despite continuous attempts to reach the family and address the growing concern from health professionals of the danger of TB transmission to other members of the family, patients continue not to adhere to procedures beyond pharmaceutical intervention.
In an attempt to directly contact the patient’s family, Dr. Haynie lead a team consisting of a local health authority physician, a TB nurse practitioner, a TB contact analyst, a nurse case manager, a county attorney, and an interpreter for unscheduled visits to family members individually.
“We had specific requests [including] keeping appointments, getting labs, and we added a deadline,” said Dr. Haynie, Chief of Disease Control and Medical Epidemiology for the Harris County Public Health & Environmental Services. “By the next Friday [we told them that] we were filing court papers with or without the information and we [would] be contacting child protective services as well.”
Following the intervention, the patient and her family adhered to testing procedures. This revealed an infant with active TB and 8 other family members with TB Infection. Isolation breaches were also discovered. Most importantly, the TB transmission cycle was interrupted, according to Dr. Haynie.
A key aspect of the team’s successful approach was to address cultural and economic barriers that hindered successful interaction with the family, TB misconceptions corrected in order for a trusting relationship to develop.
The investigators developed this intervention in Harris County, Tx, which at 4.3 million residents is the 3rd most populous U.S. county, and has reported a TB case rate of 7.6 cases per 100,000, which is approximately double that of the U.S. average, according to Dr. Haynie. Of those cases in Harris County, 73% are foreign-born, compared with the average rate of 59% in Texas.
Dr. Haynie and fellow investigators asserted part of the reason patients were so reluctant to receive treatment from the Harris County Public Health department was a combination of mistrust in the system and a number of false ideas patients have regarding TB, a sign of further educational tools being needed.
Since the first use of the intervention, Dr. Haynie and her team have implemented this approach with other non-adherent patients with relative success.
“This is something that we now do and we have not been back to court [to enforce compliance] since,” said Dr. Haynie.
[email protected]
On Twitter @eaztweets
ID Week 2017
Inappropriate C. diff. testing reduced with ‘Hard Stop’ protocol
SAN DIEGO – After other strategies to reduce inappropriate testing for Clostridium difficile infection did not provide adequate reductions in inappropriate orders, a “hard stop” protocol, which prevents testing if specific conditions are not met, reduced the rate of testing by 42% without any incidence of delayed diagnosis, according to data presented at ID Week 2017.
“Testing stewardship is really critical to minimize the frequency of false-positive [Clostridium difficile infection] cases, which of course lead to harm. They lead to inappropriate treatment, prolonged length of stay, and patient dissatisfaction,” reported Marci L. Drees, MD, Infection Prevention Officer and Hospital Epidemiologist, Christiana Care Health System, Newark, Del.
“Of course, we did, at the time, educate our clinicians about this new testing algorithm, explaining how it is so much more sensitive and that they need to be smarter about who they are testing. But as we saw the cases roll in, we noticed that many of the [colonization] cases were in patients with a history of recent laxative use,” Dr. Drees recounted.
This led initially to a “soft stop” protocol in which clinicians ordering C. difficile–infection testing received an alert if laxatives had been ordered within the previous 24 hours. The alert provided details about the laxatives and suggested that the order for C. difficile–infection testing be reconsidered. This alert was no more than a suggestion, but it did reduce C. difficile–infection testing orders by 25% at first.
“The problem was that the alert lost effect over time as people got used to seeing it and clicked right through it,” Dr. Drees explained.
Despite the diminishing effect of the soft stop, no further steps were planned until a new set of data alerted the infectious disease department that C. difficile–infection rates were higher than benchmarks. This prompted concern among the hospital leadership and led to creation of a multidisciplinary team that was given the task to dig deeper for the source of problems and develop strategies to lower rates of inappropriate testing.
When that team did their initial analysis, what really came to the front was that about half the cases that had been identified as hospital-onset C. difficile were likely only C. difficile colonizations. They either had received laxatives prior to their test or they did not have significant diarrhea,” Dr. Drees said.
It was this finding that prompted a hard stop protocol to be built into C. difficile–infection test orders. In this protocol, which is executed only in patients who have been hospitalized for at least 36 hours, two conditions must be met sequentially for the testing order to proceed. The first is there must be documentation of at least two episodes of diarrhea in the prior 24 hours. If this condition is met, then the ordering system asks for verification that the patient has not received a laxative in the prior 24 hours.
“If either of these criteria are not met, the order can only proceed if the clinician calls the lab for an override,” Dr. Drees explained. Although the person answering the phone in the laboratory does not require any additional documentation or justification, the person ordering the test must enter the name of the person in the laboratory with whom they spoke. If this field is not filled in, the order will not proceed.
Prior to the hard stop, there was an average of 12 C. difficile–infection tests ordered per day. After the hard stop, the average fell to 7 per day, a 42% decline, according to Dr. Drees. C. difficile-infection cases did not increase, and there were no incidences of delayed diagnosis resulting in adverse clinical consequences.
Of the 157 overrides on the hard stop, representing 15% of all orders, only 11% produced a positive C. difficile-infection result. It was noted that almost one third of the overrides did not follow the protocol.
“What I mean is that they did not actually call the lab. They put in their own name [for the field requiring the name of a lab worker] or they put in Mickey Mouse or they put in something, so the order would proceed,” Dr. Drees said. After followup in those cases, “we have not had repeat offenders.”
Even a hard stop is likely to have diminishing efficacy over time as clinicians identify work-arounds, Dr. Drees acknowledged. For example, there is concern that therapy for CDI will be ordered without testing, although this has not yet been detected. However, the hard stop has been more effective and shown a longer duration of effect than the soft stop, according to Dr. Drees. Although Dr. Drees acknowledged that there have been exceptions, the hard stop has “generally been well accepted.”
Dr. Drees reported that she has no financial relationships relevant to this topic.
SAN DIEGO – After other strategies to reduce inappropriate testing for Clostridium difficile infection did not provide adequate reductions in inappropriate orders, a “hard stop” protocol, which prevents testing if specific conditions are not met, reduced the rate of testing by 42% without any incidence of delayed diagnosis, according to data presented at ID Week 2017.
“Testing stewardship is really critical to minimize the frequency of false-positive [Clostridium difficile infection] cases, which of course lead to harm. They lead to inappropriate treatment, prolonged length of stay, and patient dissatisfaction,” reported Marci L. Drees, MD, Infection Prevention Officer and Hospital Epidemiologist, Christiana Care Health System, Newark, Del.
“Of course, we did, at the time, educate our clinicians about this new testing algorithm, explaining how it is so much more sensitive and that they need to be smarter about who they are testing. But as we saw the cases roll in, we noticed that many of the [colonization] cases were in patients with a history of recent laxative use,” Dr. Drees recounted.
This led initially to a “soft stop” protocol in which clinicians ordering C. difficile–infection testing received an alert if laxatives had been ordered within the previous 24 hours. The alert provided details about the laxatives and suggested that the order for C. difficile–infection testing be reconsidered. This alert was no more than a suggestion, but it did reduce C. difficile–infection testing orders by 25% at first.
“The problem was that the alert lost effect over time as people got used to seeing it and clicked right through it,” Dr. Drees explained.
Despite the diminishing effect of the soft stop, no further steps were planned until a new set of data alerted the infectious disease department that C. difficile–infection rates were higher than benchmarks. This prompted concern among the hospital leadership and led to creation of a multidisciplinary team that was given the task to dig deeper for the source of problems and develop strategies to lower rates of inappropriate testing.
When that team did their initial analysis, what really came to the front was that about half the cases that had been identified as hospital-onset C. difficile were likely only C. difficile colonizations. They either had received laxatives prior to their test or they did not have significant diarrhea,” Dr. Drees said.
It was this finding that prompted a hard stop protocol to be built into C. difficile–infection test orders. In this protocol, which is executed only in patients who have been hospitalized for at least 36 hours, two conditions must be met sequentially for the testing order to proceed. The first is there must be documentation of at least two episodes of diarrhea in the prior 24 hours. If this condition is met, then the ordering system asks for verification that the patient has not received a laxative in the prior 24 hours.
“If either of these criteria are not met, the order can only proceed if the clinician calls the lab for an override,” Dr. Drees explained. Although the person answering the phone in the laboratory does not require any additional documentation or justification, the person ordering the test must enter the name of the person in the laboratory with whom they spoke. If this field is not filled in, the order will not proceed.
Prior to the hard stop, there was an average of 12 C. difficile–infection tests ordered per day. After the hard stop, the average fell to 7 per day, a 42% decline, according to Dr. Drees. C. difficile-infection cases did not increase, and there were no incidences of delayed diagnosis resulting in adverse clinical consequences.
Of the 157 overrides on the hard stop, representing 15% of all orders, only 11% produced a positive C. difficile-infection result. It was noted that almost one third of the overrides did not follow the protocol.
“What I mean is that they did not actually call the lab. They put in their own name [for the field requiring the name of a lab worker] or they put in Mickey Mouse or they put in something, so the order would proceed,” Dr. Drees said. After followup in those cases, “we have not had repeat offenders.”
Even a hard stop is likely to have diminishing efficacy over time as clinicians identify work-arounds, Dr. Drees acknowledged. For example, there is concern that therapy for CDI will be ordered without testing, although this has not yet been detected. However, the hard stop has been more effective and shown a longer duration of effect than the soft stop, according to Dr. Drees. Although Dr. Drees acknowledged that there have been exceptions, the hard stop has “generally been well accepted.”
Dr. Drees reported that she has no financial relationships relevant to this topic.
SAN DIEGO – After other strategies to reduce inappropriate testing for Clostridium difficile infection did not provide adequate reductions in inappropriate orders, a “hard stop” protocol, which prevents testing if specific conditions are not met, reduced the rate of testing by 42% without any incidence of delayed diagnosis, according to data presented at ID Week 2017.
“Testing stewardship is really critical to minimize the frequency of false-positive [Clostridium difficile infection] cases, which of course lead to harm. They lead to inappropriate treatment, prolonged length of stay, and patient dissatisfaction,” reported Marci L. Drees, MD, Infection Prevention Officer and Hospital Epidemiologist, Christiana Care Health System, Newark, Del.
“Of course, we did, at the time, educate our clinicians about this new testing algorithm, explaining how it is so much more sensitive and that they need to be smarter about who they are testing. But as we saw the cases roll in, we noticed that many of the [colonization] cases were in patients with a history of recent laxative use,” Dr. Drees recounted.
This led initially to a “soft stop” protocol in which clinicians ordering C. difficile–infection testing received an alert if laxatives had been ordered within the previous 24 hours. The alert provided details about the laxatives and suggested that the order for C. difficile–infection testing be reconsidered. This alert was no more than a suggestion, but it did reduce C. difficile–infection testing orders by 25% at first.
“The problem was that the alert lost effect over time as people got used to seeing it and clicked right through it,” Dr. Drees explained.
Despite the diminishing effect of the soft stop, no further steps were planned until a new set of data alerted the infectious disease department that C. difficile–infection rates were higher than benchmarks. This prompted concern among the hospital leadership and led to creation of a multidisciplinary team that was given the task to dig deeper for the source of problems and develop strategies to lower rates of inappropriate testing.
When that team did their initial analysis, what really came to the front was that about half the cases that had been identified as hospital-onset C. difficile were likely only C. difficile colonizations. They either had received laxatives prior to their test or they did not have significant diarrhea,” Dr. Drees said.
It was this finding that prompted a hard stop protocol to be built into C. difficile–infection test orders. In this protocol, which is executed only in patients who have been hospitalized for at least 36 hours, two conditions must be met sequentially for the testing order to proceed. The first is there must be documentation of at least two episodes of diarrhea in the prior 24 hours. If this condition is met, then the ordering system asks for verification that the patient has not received a laxative in the prior 24 hours.
“If either of these criteria are not met, the order can only proceed if the clinician calls the lab for an override,” Dr. Drees explained. Although the person answering the phone in the laboratory does not require any additional documentation or justification, the person ordering the test must enter the name of the person in the laboratory with whom they spoke. If this field is not filled in, the order will not proceed.
Prior to the hard stop, there was an average of 12 C. difficile–infection tests ordered per day. After the hard stop, the average fell to 7 per day, a 42% decline, according to Dr. Drees. C. difficile-infection cases did not increase, and there were no incidences of delayed diagnosis resulting in adverse clinical consequences.
Of the 157 overrides on the hard stop, representing 15% of all orders, only 11% produced a positive C. difficile-infection result. It was noted that almost one third of the overrides did not follow the protocol.
“What I mean is that they did not actually call the lab. They put in their own name [for the field requiring the name of a lab worker] or they put in Mickey Mouse or they put in something, so the order would proceed,” Dr. Drees said. After followup in those cases, “we have not had repeat offenders.”
Even a hard stop is likely to have diminishing efficacy over time as clinicians identify work-arounds, Dr. Drees acknowledged. For example, there is concern that therapy for CDI will be ordered without testing, although this has not yet been detected. However, the hard stop has been more effective and shown a longer duration of effect than the soft stop, according to Dr. Drees. Although Dr. Drees acknowledged that there have been exceptions, the hard stop has “generally been well accepted.”
Dr. Drees reported that she has no financial relationships relevant to this topic.
ID WEEK 2017
Key clinical point:
Major finding: After a hard stop protocol was implemented, the average per day rate of C. diff testing at a tertiary medical center was reduced 42%.
Data source: Prospective performance improvement project.
Disclosures: Dr. Drees reported that she has no financial relationships relevant to this topic.