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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.
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.
Study eyes factors that may trigger breakthrough bacteremia
SAN DIEGO – , according to a detailed study of six isolates.
“Both patient and microbe factors can contribute to treatment failure, even involving pan-susceptible isolates,” Andrew Berti, PharmD, PhD, said in an interview prior to an annual scientific meeting on infectious diseases.
The researchers presented the case of a patient who experienced multiple episodes of breakthrough Staphylococcus aureus bacteremia over a period of 5 years in the setting of appropriately dosed antimicrobial suppressive therapy. They recovered six clinical bloodstream isolates from the patient during distinct episodes of methicillin-susceptible S. aureus (MSSA) bacteremia, and it was determined that a central line infection was the source for each episode. Isolates recovered were susceptible to the individual therapies received, which included oxacillin, daptomycin, and dalbavancin. The researchers used Illumina technology to collect bacterial whole genome sequence data. “Relatively little is known about bacterial evolution during human infection as these tend to be acute, rapidly resolved events,” Dr. Berti said. “This case was unique in that we could observe changes to a pathogen over a more than 6 years period as it adapted to survive host defenses and multiple antibiotic interventions.”
The researchers discovered that the first two isolates (ST256) and the last four isolates (ST5) “represent distinct populations and suggest that a distinct MSSA strain displaced the previous population between bacteremia episodes 2 and 3,” they wrote in their abstract. “Of note, all of these strains were able to survive and establish breakthrough bacteremias despite favorable susceptibility profiles to the agents used as suppressive therapy. Although the MICs remain low and in the susceptible range to oxacillin, daptomycin, and dalbavancin, these isolates progressively developed significant antimicrobial tolerance phenotypes, which coincided with mutations in walK (yycG), htrA2, ftsW, ebh, and ileS that may be advantageous to survival under antibiotic pressure.”
Dr. Berti acknowledged certain limitations of the analysis, including the inability to test for heteroresistance to some antibiotics, which may also contribute to treatment failure. “Specific therapeutic interventions that coincide with bacterial population changes are not necessarily causative of those changes,” he said. One of the study authors, Warren Rose, PharmD, disclosed having received research grants, speaker honoraria, and/or consulting fees from Theravance, Merck, The Medicines Company and Visante, Inc. All other authors reported having no financial disclosures.
SAN DIEGO – , according to a detailed study of six isolates.
“Both patient and microbe factors can contribute to treatment failure, even involving pan-susceptible isolates,” Andrew Berti, PharmD, PhD, said in an interview prior to an annual scientific meeting on infectious diseases.
The researchers presented the case of a patient who experienced multiple episodes of breakthrough Staphylococcus aureus bacteremia over a period of 5 years in the setting of appropriately dosed antimicrobial suppressive therapy. They recovered six clinical bloodstream isolates from the patient during distinct episodes of methicillin-susceptible S. aureus (MSSA) bacteremia, and it was determined that a central line infection was the source for each episode. Isolates recovered were susceptible to the individual therapies received, which included oxacillin, daptomycin, and dalbavancin. The researchers used Illumina technology to collect bacterial whole genome sequence data. “Relatively little is known about bacterial evolution during human infection as these tend to be acute, rapidly resolved events,” Dr. Berti said. “This case was unique in that we could observe changes to a pathogen over a more than 6 years period as it adapted to survive host defenses and multiple antibiotic interventions.”
The researchers discovered that the first two isolates (ST256) and the last four isolates (ST5) “represent distinct populations and suggest that a distinct MSSA strain displaced the previous population between bacteremia episodes 2 and 3,” they wrote in their abstract. “Of note, all of these strains were able to survive and establish breakthrough bacteremias despite favorable susceptibility profiles to the agents used as suppressive therapy. Although the MICs remain low and in the susceptible range to oxacillin, daptomycin, and dalbavancin, these isolates progressively developed significant antimicrobial tolerance phenotypes, which coincided with mutations in walK (yycG), htrA2, ftsW, ebh, and ileS that may be advantageous to survival under antibiotic pressure.”
Dr. Berti acknowledged certain limitations of the analysis, including the inability to test for heteroresistance to some antibiotics, which may also contribute to treatment failure. “Specific therapeutic interventions that coincide with bacterial population changes are not necessarily causative of those changes,” he said. One of the study authors, Warren Rose, PharmD, disclosed having received research grants, speaker honoraria, and/or consulting fees from Theravance, Merck, The Medicines Company and Visante, Inc. All other authors reported having no financial disclosures.
SAN DIEGO – , according to a detailed study of six isolates.
“Both patient and microbe factors can contribute to treatment failure, even involving pan-susceptible isolates,” Andrew Berti, PharmD, PhD, said in an interview prior to an annual scientific meeting on infectious diseases.
The researchers presented the case of a patient who experienced multiple episodes of breakthrough Staphylococcus aureus bacteremia over a period of 5 years in the setting of appropriately dosed antimicrobial suppressive therapy. They recovered six clinical bloodstream isolates from the patient during distinct episodes of methicillin-susceptible S. aureus (MSSA) bacteremia, and it was determined that a central line infection was the source for each episode. Isolates recovered were susceptible to the individual therapies received, which included oxacillin, daptomycin, and dalbavancin. The researchers used Illumina technology to collect bacterial whole genome sequence data. “Relatively little is known about bacterial evolution during human infection as these tend to be acute, rapidly resolved events,” Dr. Berti said. “This case was unique in that we could observe changes to a pathogen over a more than 6 years period as it adapted to survive host defenses and multiple antibiotic interventions.”
The researchers discovered that the first two isolates (ST256) and the last four isolates (ST5) “represent distinct populations and suggest that a distinct MSSA strain displaced the previous population between bacteremia episodes 2 and 3,” they wrote in their abstract. “Of note, all of these strains were able to survive and establish breakthrough bacteremias despite favorable susceptibility profiles to the agents used as suppressive therapy. Although the MICs remain low and in the susceptible range to oxacillin, daptomycin, and dalbavancin, these isolates progressively developed significant antimicrobial tolerance phenotypes, which coincided with mutations in walK (yycG), htrA2, ftsW, ebh, and ileS that may be advantageous to survival under antibiotic pressure.”
Dr. Berti acknowledged certain limitations of the analysis, including the inability to test for heteroresistance to some antibiotics, which may also contribute to treatment failure. “Specific therapeutic interventions that coincide with bacterial population changes are not necessarily causative of those changes,” he said. One of the study authors, Warren Rose, PharmD, disclosed having received research grants, speaker honoraria, and/or consulting fees from Theravance, Merck, The Medicines Company and Visante, Inc. All other authors reported having no financial disclosures.
REPORTING FROM ID WEEK 2017
Key clinical point: Both patient and microbe factors can contribute to antibitoic treatment failure.
Major finding: Two distinct Staphylococcus aureus lineages were islolated over a period of 5 years, and each was able to persist despite appropriate antibitoic interventions.
Study details: Clinical analysis of six bloodstream isolates from a singles patient over a 5-year period.
Disclosures: One of the study authors, Warren Rose, PharmD, disclosed having received research grants, speaker honoraria and/or consulting fees from Theravance, Merck, The Medicines Company and Visante. All other authors reported having no financial disclosures.
Behavioral approach to appropriate antimicrobial prescribing in hospitals: The DUMAS study
Clinical question: How effective is an antimicrobial stewardship approach grounded in behavioral theory and focused on preserving prescriber autonomy and participation in improving appropriateness of antimicrobial prescribing in hospitals?
Background: Antimicrobial stewardship programs aim to achieve the goal of improving antimicrobial prescribing. This leads to significant benefits, including decreased antimicrobial resistance, improved clinical outcomes (lower morbidity and mortality), and lower health care costs. Stewardship programs do not often focus on the human behavior element of the prescribing physicians. Changing antimicrobial prescribing is a complex behavioral process, and there is a known persistent resistance between prescribers and the stewardship team. In a simple sense, this resistance is generated by tension created when prescribers do not have autonomy.
Previous studies that used interventions based on behavioral theory found promising results, but none of them were in a hospital setting. Rather, most of these studies had a narrow focus of respiratory tract infections in outpatient clinics.
Setting: Seven clinical departments (two medical, three surgical, and two pediatric) in a tertiary care medical center and a general teaching hospital, both in Amsterdam. The first hospital was a 700-bed tertiary care center with salaried specialists, while the second hospital was a 550-bed general medical center with self-employed specialists.
Synopsis: During a baseline period of 16 months and an intervention period of 12 months, physicians who prescribed systemic antimicrobial drugs for any indication were included in the study. In all, 1,121 patient cases with 700 prescriptions were studied during the baseline period and 882 patient cases with 531 prescriptions were studied during the intervention period. The intervention was as follows: Prescribers were offered a free choice of how to improve their antimicrobial prescribing. They were stimulated to choose interventions with higher potential for success based on a root cause analysis of inappropriate prescribing. The study was inspired by the participatory action research paradigm, which focuses on collaboration and empowerment of the stakeholders in the change process. In this study, prescribers were given reports of root cause analysis of their prior prescribing patterns. Then, they were invited to choose and codevelop one or more interventions that were tailored and individualized to improve their own prescribing. This approach draws on the following three behavioral principles: 1) respect for the prescriber’s autonomy to avoid feelings of resistance; 2) the inclination that people have to value a product higher and feel more ownership of it if they made it themselves (the IKEA effect); 3) the tendency of people to follow up on an active and public commitment.
The primary outcome was antimicrobial appropriateness, measured with a validated appropriateness assessment instrument. One of three infectious disease specialists assessed the adult prescriptions, and one of three infectious disease/immunology pediatricians assessed the pediatric prescriptions for appropriateness. Appropriateness criteria were as follows: indication, choice of antimicrobial, dosage, route, and duration. A secondary outcome was antimicrobial consumption, reported as days of therapy per 100 admissions per month. Other outcomes were changes in specific appropriateness categories, intravenous antimicrobial consumption, consumption of specific antimicrobial subgroups, and length of hospital stay.
The mean antimicrobial appropriateness increased from 64.1% at intervention start to 77.4% at 12-month follow-up (+13.3%; relative risk, 1.17; 95% CI, 1.04-1.27), without a change in slope. Antimicrobial consumption remained the same during both study periods. Length of hospital stay did not change relative to the start of the intervention approach.
This is the first study of its kind, as a hospital antimicrobial stewardship program study grounded in behavioral science, with the key element being the free choice allowed to the prescribers, who made their own autonomous decisions about how to improve their prescribing. The authors hypothesize that the prescribers felt relatively nonthreatened by their approach since the prescribers maintained their free will to change their own behavior if so desired. The prescribers were given a free intervention choice. For example, they could have just chosen “education” as an easy out; however, the root cause analysis seemed to be an impetus for the prescribers to choose interventions that would be more effective. A prior study in a nursing home setting was unsuccessful; aside from other differences, that study used a predetermined set of interventions, thus lacking the autonomy and IKEA effect seen in this study.
Bottom line: Use of a behavioral approach that preserves prescriber autonomy resulted in an increase in antimicrobial appropriateness sustained for at least 12 months. The intervention is effective, inexpensive, and transferable to various health care settings.
Citation: Sikkens JJ, van Agtmael MA, Peters EJG, et al. Behavioral approach to appropriate antimicrobial prescribing in hospitals: The dutch unique method for antimicrobial stewardship (DUMAS) participatoryintervention study. JAMA Intern Med. Published online May 1, 2017. doi: 10.1001/jamainternmed.2017.0946.
Dr. Ramee is a hospitalist at Ochsner Health System, New Orleans.
Clinical question: How effective is an antimicrobial stewardship approach grounded in behavioral theory and focused on preserving prescriber autonomy and participation in improving appropriateness of antimicrobial prescribing in hospitals?
Background: Antimicrobial stewardship programs aim to achieve the goal of improving antimicrobial prescribing. This leads to significant benefits, including decreased antimicrobial resistance, improved clinical outcomes (lower morbidity and mortality), and lower health care costs. Stewardship programs do not often focus on the human behavior element of the prescribing physicians. Changing antimicrobial prescribing is a complex behavioral process, and there is a known persistent resistance between prescribers and the stewardship team. In a simple sense, this resistance is generated by tension created when prescribers do not have autonomy.
Previous studies that used interventions based on behavioral theory found promising results, but none of them were in a hospital setting. Rather, most of these studies had a narrow focus of respiratory tract infections in outpatient clinics.
Setting: Seven clinical departments (two medical, three surgical, and two pediatric) in a tertiary care medical center and a general teaching hospital, both in Amsterdam. The first hospital was a 700-bed tertiary care center with salaried specialists, while the second hospital was a 550-bed general medical center with self-employed specialists.
Synopsis: During a baseline period of 16 months and an intervention period of 12 months, physicians who prescribed systemic antimicrobial drugs for any indication were included in the study. In all, 1,121 patient cases with 700 prescriptions were studied during the baseline period and 882 patient cases with 531 prescriptions were studied during the intervention period. The intervention was as follows: Prescribers were offered a free choice of how to improve their antimicrobial prescribing. They were stimulated to choose interventions with higher potential for success based on a root cause analysis of inappropriate prescribing. The study was inspired by the participatory action research paradigm, which focuses on collaboration and empowerment of the stakeholders in the change process. In this study, prescribers were given reports of root cause analysis of their prior prescribing patterns. Then, they were invited to choose and codevelop one or more interventions that were tailored and individualized to improve their own prescribing. This approach draws on the following three behavioral principles: 1) respect for the prescriber’s autonomy to avoid feelings of resistance; 2) the inclination that people have to value a product higher and feel more ownership of it if they made it themselves (the IKEA effect); 3) the tendency of people to follow up on an active and public commitment.
The primary outcome was antimicrobial appropriateness, measured with a validated appropriateness assessment instrument. One of three infectious disease specialists assessed the adult prescriptions, and one of three infectious disease/immunology pediatricians assessed the pediatric prescriptions for appropriateness. Appropriateness criteria were as follows: indication, choice of antimicrobial, dosage, route, and duration. A secondary outcome was antimicrobial consumption, reported as days of therapy per 100 admissions per month. Other outcomes were changes in specific appropriateness categories, intravenous antimicrobial consumption, consumption of specific antimicrobial subgroups, and length of hospital stay.
The mean antimicrobial appropriateness increased from 64.1% at intervention start to 77.4% at 12-month follow-up (+13.3%; relative risk, 1.17; 95% CI, 1.04-1.27), without a change in slope. Antimicrobial consumption remained the same during both study periods. Length of hospital stay did not change relative to the start of the intervention approach.
This is the first study of its kind, as a hospital antimicrobial stewardship program study grounded in behavioral science, with the key element being the free choice allowed to the prescribers, who made their own autonomous decisions about how to improve their prescribing. The authors hypothesize that the prescribers felt relatively nonthreatened by their approach since the prescribers maintained their free will to change their own behavior if so desired. The prescribers were given a free intervention choice. For example, they could have just chosen “education” as an easy out; however, the root cause analysis seemed to be an impetus for the prescribers to choose interventions that would be more effective. A prior study in a nursing home setting was unsuccessful; aside from other differences, that study used a predetermined set of interventions, thus lacking the autonomy and IKEA effect seen in this study.
Bottom line: Use of a behavioral approach that preserves prescriber autonomy resulted in an increase in antimicrobial appropriateness sustained for at least 12 months. The intervention is effective, inexpensive, and transferable to various health care settings.
Citation: Sikkens JJ, van Agtmael MA, Peters EJG, et al. Behavioral approach to appropriate antimicrobial prescribing in hospitals: The dutch unique method for antimicrobial stewardship (DUMAS) participatoryintervention study. JAMA Intern Med. Published online May 1, 2017. doi: 10.1001/jamainternmed.2017.0946.
Dr. Ramee is a hospitalist at Ochsner Health System, New Orleans.
Clinical question: How effective is an antimicrobial stewardship approach grounded in behavioral theory and focused on preserving prescriber autonomy and participation in improving appropriateness of antimicrobial prescribing in hospitals?
Background: Antimicrobial stewardship programs aim to achieve the goal of improving antimicrobial prescribing. This leads to significant benefits, including decreased antimicrobial resistance, improved clinical outcomes (lower morbidity and mortality), and lower health care costs. Stewardship programs do not often focus on the human behavior element of the prescribing physicians. Changing antimicrobial prescribing is a complex behavioral process, and there is a known persistent resistance between prescribers and the stewardship team. In a simple sense, this resistance is generated by tension created when prescribers do not have autonomy.
Previous studies that used interventions based on behavioral theory found promising results, but none of them were in a hospital setting. Rather, most of these studies had a narrow focus of respiratory tract infections in outpatient clinics.
Setting: Seven clinical departments (two medical, three surgical, and two pediatric) in a tertiary care medical center and a general teaching hospital, both in Amsterdam. The first hospital was a 700-bed tertiary care center with salaried specialists, while the second hospital was a 550-bed general medical center with self-employed specialists.
Synopsis: During a baseline period of 16 months and an intervention period of 12 months, physicians who prescribed systemic antimicrobial drugs for any indication were included in the study. In all, 1,121 patient cases with 700 prescriptions were studied during the baseline period and 882 patient cases with 531 prescriptions were studied during the intervention period. The intervention was as follows: Prescribers were offered a free choice of how to improve their antimicrobial prescribing. They were stimulated to choose interventions with higher potential for success based on a root cause analysis of inappropriate prescribing. The study was inspired by the participatory action research paradigm, which focuses on collaboration and empowerment of the stakeholders in the change process. In this study, prescribers were given reports of root cause analysis of their prior prescribing patterns. Then, they were invited to choose and codevelop one or more interventions that were tailored and individualized to improve their own prescribing. This approach draws on the following three behavioral principles: 1) respect for the prescriber’s autonomy to avoid feelings of resistance; 2) the inclination that people have to value a product higher and feel more ownership of it if they made it themselves (the IKEA effect); 3) the tendency of people to follow up on an active and public commitment.
The primary outcome was antimicrobial appropriateness, measured with a validated appropriateness assessment instrument. One of three infectious disease specialists assessed the adult prescriptions, and one of three infectious disease/immunology pediatricians assessed the pediatric prescriptions for appropriateness. Appropriateness criteria were as follows: indication, choice of antimicrobial, dosage, route, and duration. A secondary outcome was antimicrobial consumption, reported as days of therapy per 100 admissions per month. Other outcomes were changes in specific appropriateness categories, intravenous antimicrobial consumption, consumption of specific antimicrobial subgroups, and length of hospital stay.
The mean antimicrobial appropriateness increased from 64.1% at intervention start to 77.4% at 12-month follow-up (+13.3%; relative risk, 1.17; 95% CI, 1.04-1.27), without a change in slope. Antimicrobial consumption remained the same during both study periods. Length of hospital stay did not change relative to the start of the intervention approach.
This is the first study of its kind, as a hospital antimicrobial stewardship program study grounded in behavioral science, with the key element being the free choice allowed to the prescribers, who made their own autonomous decisions about how to improve their prescribing. The authors hypothesize that the prescribers felt relatively nonthreatened by their approach since the prescribers maintained their free will to change their own behavior if so desired. The prescribers were given a free intervention choice. For example, they could have just chosen “education” as an easy out; however, the root cause analysis seemed to be an impetus for the prescribers to choose interventions that would be more effective. A prior study in a nursing home setting was unsuccessful; aside from other differences, that study used a predetermined set of interventions, thus lacking the autonomy and IKEA effect seen in this study.
Bottom line: Use of a behavioral approach that preserves prescriber autonomy resulted in an increase in antimicrobial appropriateness sustained for at least 12 months. The intervention is effective, inexpensive, and transferable to various health care settings.
Citation: Sikkens JJ, van Agtmael MA, Peters EJG, et al. Behavioral approach to appropriate antimicrobial prescribing in hospitals: The dutch unique method for antimicrobial stewardship (DUMAS) participatoryintervention study. JAMA Intern Med. Published online May 1, 2017. doi: 10.1001/jamainternmed.2017.0946.
Dr. Ramee is a hospitalist at Ochsner Health System, New Orleans.
HIV antiretroviral resistance can affect more than 10% of pregnant women
SAN DIEGO – HIV antiretroviral resistance can affect more than 10% of pregnant women, even if they are previously treatment naive, results of a case-control study demonstrated.
“Furthermore, if there is an HIV-infected infant who received HIV prophylaxis with zidovudine and nevirapine, the infant may have developed resistance to the nonnucleoside reverse transcriptase inhibitors [NNRTIs] class of medications, and timely antiretroviral-resistant testing is an important step prior to choosing an appropriate regimen,” Nava Yeganeh, MD, said in an interview prior to an annual scientific meeting on infectious diseases.
In all, 140 infants were HIV infected, and 13 had drug-resistant mutations. Of the 606 women who had sufficient nucleic acid amplification for resistance testing, 63 (10.4%) had drug-resistant mutations against one or more classes of antiretrovirals. “These mothers may have been infected with a drug-resistant strain of HIV, which they then may have passed on to their infants,” Dr. Yeganeh said. “We also found that 3 of the 13 HIV-infected infants with drug-resistant mutations against NNRTIs were born to mothers who did not have a resistant strain of HIV. These three infants likely developed resistance because of the infant prophylaxis they received with nevirapine.”
Univariate and multivariate analyses revealed that drug-resistant mutation in mothers was not associated with increased risk of HIV mother-to-child transmission (adjusted odds ratio, 0.79). The only predictors of mother-to-child transmission were log HIV viral load (OR, 1.4) and infant prophylaxis arm with a two-drug regimen (OR, 1.6). In addition, the presence of drug-resistant mutations in mothers who transmitted was strongly associated with presence of drug-resistant mutations in infants (P less than .001).
A key limitation of the trial, Dr. Yeganeh said, was that it was completed in 2011. “Antiretroviral-resistant HIV may be even more common now that antiretrovirals are more available,” she 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. She reported having no financial disclosures.
SAN DIEGO – HIV antiretroviral resistance can affect more than 10% of pregnant women, even if they are previously treatment naive, results of a case-control study demonstrated.
“Furthermore, if there is an HIV-infected infant who received HIV prophylaxis with zidovudine and nevirapine, the infant may have developed resistance to the nonnucleoside reverse transcriptase inhibitors [NNRTIs] class of medications, and timely antiretroviral-resistant testing is an important step prior to choosing an appropriate regimen,” Nava Yeganeh, MD, said in an interview prior to an annual scientific meeting on infectious diseases.
In all, 140 infants were HIV infected, and 13 had drug-resistant mutations. Of the 606 women who had sufficient nucleic acid amplification for resistance testing, 63 (10.4%) had drug-resistant mutations against one or more classes of antiretrovirals. “These mothers may have been infected with a drug-resistant strain of HIV, which they then may have passed on to their infants,” Dr. Yeganeh said. “We also found that 3 of the 13 HIV-infected infants with drug-resistant mutations against NNRTIs were born to mothers who did not have a resistant strain of HIV. These three infants likely developed resistance because of the infant prophylaxis they received with nevirapine.”
Univariate and multivariate analyses revealed that drug-resistant mutation in mothers was not associated with increased risk of HIV mother-to-child transmission (adjusted odds ratio, 0.79). The only predictors of mother-to-child transmission were log HIV viral load (OR, 1.4) and infant prophylaxis arm with a two-drug regimen (OR, 1.6). In addition, the presence of drug-resistant mutations in mothers who transmitted was strongly associated with presence of drug-resistant mutations in infants (P less than .001).
A key limitation of the trial, Dr. Yeganeh said, was that it was completed in 2011. “Antiretroviral-resistant HIV may be even more common now that antiretrovirals are more available,” she 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. She reported having no financial disclosures.
SAN DIEGO – HIV antiretroviral resistance can affect more than 10% of pregnant women, even if they are previously treatment naive, results of a case-control study demonstrated.
“Furthermore, if there is an HIV-infected infant who received HIV prophylaxis with zidovudine and nevirapine, the infant may have developed resistance to the nonnucleoside reverse transcriptase inhibitors [NNRTIs] class of medications, and timely antiretroviral-resistant testing is an important step prior to choosing an appropriate regimen,” Nava Yeganeh, MD, said in an interview prior to an annual scientific meeting on infectious diseases.
In all, 140 infants were HIV infected, and 13 had drug-resistant mutations. Of the 606 women who had sufficient nucleic acid amplification for resistance testing, 63 (10.4%) had drug-resistant mutations against one or more classes of antiretrovirals. “These mothers may have been infected with a drug-resistant strain of HIV, which they then may have passed on to their infants,” Dr. Yeganeh said. “We also found that 3 of the 13 HIV-infected infants with drug-resistant mutations against NNRTIs were born to mothers who did not have a resistant strain of HIV. These three infants likely developed resistance because of the infant prophylaxis they received with nevirapine.”
Univariate and multivariate analyses revealed that drug-resistant mutation in mothers was not associated with increased risk of HIV mother-to-child transmission (adjusted odds ratio, 0.79). The only predictors of mother-to-child transmission were log HIV viral load (OR, 1.4) and infant prophylaxis arm with a two-drug regimen (OR, 1.6). In addition, the presence of drug-resistant mutations in mothers who transmitted was strongly associated with presence of drug-resistant mutations in infants (P less than .001).
A key limitation of the trial, Dr. Yeganeh said, was that it was completed in 2011. “Antiretroviral-resistant HIV may be even more common now that antiretrovirals are more available,” she 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. She reported having no financial disclosures.
AT IDWEEK 2017
Key clinical point:
Major finding: Of 606 women who had sufficient nucleic acid amplification for resistance testing, 63 (10.4%) had drug-resistant mutations against one or more classes of antiretrovirals.
Study details: A case-control study of blood samples from 606 HIV-infected pregnant women and their infants.
Disclosures: Dr. Yeganeh reported having no financial disclosures.
Expanding treatment options to deal with antibiotic resistance
SAN DIEGO – In an era of rising antibiotic resistance, new potential treatment options and policy changes took the stage at the start of an annual scientific meeting on infectious diseases.
Presenters covered emerging topics addressing infectious diseases, with a strong focus on HIV. A common emphasis, among all presentations, was the pressing need to update availability of newer and more effective drugs.
“There’s always something hot in ID, and often it’s transient. But what isn’t transient is the overwhelming problem of antibiotic resistance,” said Stan Deresinski, MD, infectious disease specialist from Stanford (Calif.) University. He added that: “A fear come true is the merger of antibiotic resistance and increased virulence.”
While long-term solutions are needed, a short-term answer is the increase in the kinds of antibiotics available, Dr. Deresinski said.
“As we look at this sort of event, we begin to look at ourselves in the near future as plague doctors,” warned Dr. Deresinski. “We need to deal with this, and the thing that can be done in the short term is the development of new antibiotics.”
The Food and Drug Administration has several avenues that could be used to provide for expedited antibiotics approval, such as fast tracking and priority approval of drugs. An additional program called Generating Antibiotic Incentives Now (GAIN) that allows the FDA to designate an antibiotic as an anti-infectious disease product, making it eligible for fast tracking and priority approval, as well as the addition of 5 years of market exclusivity, may be used to incentivize the development of newer drugs.
In addition, Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) and the Antibacterial Resistance Leadership Group (ARLG) are two groups that will be essential for accelerating antibiotic development, Dr. Deresinski said.
CARB-X, which is a public-private partnership created by a White House executive order in 2014, focuses on preclinical discovery and development, and ARLG works under the mission statement, “prioritize, design, and execute clinical research that will reduce public health threat of antibacterial resistance.”
Among the hot topics in HIV, presenters described a series of studies conducted throughout the year assessing prexposure prophylaxis (PrEP), and how interventions, such as the use of the drug tenofovir, can increase efficacy of oral prophylaxis in preventing HIV-1 transmission.
In a test of antiretroviral therapy, the use of long-acting intramuscular injectable therapy every 4 and 8 weeks had huge improvement in patient approval, 88% and 89% respectively, compared with the 43% approval rate that oral HIV-1 medications received, said Wendy Armstrong, MD, of Emory University, Atlanta.
“[This] therapy is really getting to the point that we dreamed of 25 years ago, when our goals were finding an effective agent: to have simple agents, less frequent dosing schemes, limited adverse effects, and limited drug-to-drug interaction,” said Dr. Armstrong.
Among other topics to be addressed at the conference, Dr. Deresinski noted that the recent drop in Zika infections, as well as an uptick seen in hepatitis A outbreaks among the homeless and drug-user populations, would be discussed later in the week.
[email protected]
On Twitter @eaztweets
SAN DIEGO – In an era of rising antibiotic resistance, new potential treatment options and policy changes took the stage at the start of an annual scientific meeting on infectious diseases.
Presenters covered emerging topics addressing infectious diseases, with a strong focus on HIV. A common emphasis, among all presentations, was the pressing need to update availability of newer and more effective drugs.
“There’s always something hot in ID, and often it’s transient. But what isn’t transient is the overwhelming problem of antibiotic resistance,” said Stan Deresinski, MD, infectious disease specialist from Stanford (Calif.) University. He added that: “A fear come true is the merger of antibiotic resistance and increased virulence.”
While long-term solutions are needed, a short-term answer is the increase in the kinds of antibiotics available, Dr. Deresinski said.
“As we look at this sort of event, we begin to look at ourselves in the near future as plague doctors,” warned Dr. Deresinski. “We need to deal with this, and the thing that can be done in the short term is the development of new antibiotics.”
The Food and Drug Administration has several avenues that could be used to provide for expedited antibiotics approval, such as fast tracking and priority approval of drugs. An additional program called Generating Antibiotic Incentives Now (GAIN) that allows the FDA to designate an antibiotic as an anti-infectious disease product, making it eligible for fast tracking and priority approval, as well as the addition of 5 years of market exclusivity, may be used to incentivize the development of newer drugs.
In addition, Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) and the Antibacterial Resistance Leadership Group (ARLG) are two groups that will be essential for accelerating antibiotic development, Dr. Deresinski said.
CARB-X, which is a public-private partnership created by a White House executive order in 2014, focuses on preclinical discovery and development, and ARLG works under the mission statement, “prioritize, design, and execute clinical research that will reduce public health threat of antibacterial resistance.”
Among the hot topics in HIV, presenters described a series of studies conducted throughout the year assessing prexposure prophylaxis (PrEP), and how interventions, such as the use of the drug tenofovir, can increase efficacy of oral prophylaxis in preventing HIV-1 transmission.
In a test of antiretroviral therapy, the use of long-acting intramuscular injectable therapy every 4 and 8 weeks had huge improvement in patient approval, 88% and 89% respectively, compared with the 43% approval rate that oral HIV-1 medications received, said Wendy Armstrong, MD, of Emory University, Atlanta.
“[This] therapy is really getting to the point that we dreamed of 25 years ago, when our goals were finding an effective agent: to have simple agents, less frequent dosing schemes, limited adverse effects, and limited drug-to-drug interaction,” said Dr. Armstrong.
Among other topics to be addressed at the conference, Dr. Deresinski noted that the recent drop in Zika infections, as well as an uptick seen in hepatitis A outbreaks among the homeless and drug-user populations, would be discussed later in the week.
[email protected]
On Twitter @eaztweets
SAN DIEGO – In an era of rising antibiotic resistance, new potential treatment options and policy changes took the stage at the start of an annual scientific meeting on infectious diseases.
Presenters covered emerging topics addressing infectious diseases, with a strong focus on HIV. A common emphasis, among all presentations, was the pressing need to update availability of newer and more effective drugs.
“There’s always something hot in ID, and often it’s transient. But what isn’t transient is the overwhelming problem of antibiotic resistance,” said Stan Deresinski, MD, infectious disease specialist from Stanford (Calif.) University. He added that: “A fear come true is the merger of antibiotic resistance and increased virulence.”
While long-term solutions are needed, a short-term answer is the increase in the kinds of antibiotics available, Dr. Deresinski said.
“As we look at this sort of event, we begin to look at ourselves in the near future as plague doctors,” warned Dr. Deresinski. “We need to deal with this, and the thing that can be done in the short term is the development of new antibiotics.”
The Food and Drug Administration has several avenues that could be used to provide for expedited antibiotics approval, such as fast tracking and priority approval of drugs. An additional program called Generating Antibiotic Incentives Now (GAIN) that allows the FDA to designate an antibiotic as an anti-infectious disease product, making it eligible for fast tracking and priority approval, as well as the addition of 5 years of market exclusivity, may be used to incentivize the development of newer drugs.
In addition, Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) and the Antibacterial Resistance Leadership Group (ARLG) are two groups that will be essential for accelerating antibiotic development, Dr. Deresinski said.
CARB-X, which is a public-private partnership created by a White House executive order in 2014, focuses on preclinical discovery and development, and ARLG works under the mission statement, “prioritize, design, and execute clinical research that will reduce public health threat of antibacterial resistance.”
Among the hot topics in HIV, presenters described a series of studies conducted throughout the year assessing prexposure prophylaxis (PrEP), and how interventions, such as the use of the drug tenofovir, can increase efficacy of oral prophylaxis in preventing HIV-1 transmission.
In a test of antiretroviral therapy, the use of long-acting intramuscular injectable therapy every 4 and 8 weeks had huge improvement in patient approval, 88% and 89% respectively, compared with the 43% approval rate that oral HIV-1 medications received, said Wendy Armstrong, MD, of Emory University, Atlanta.
“[This] therapy is really getting to the point that we dreamed of 25 years ago, when our goals were finding an effective agent: to have simple agents, less frequent dosing schemes, limited adverse effects, and limited drug-to-drug interaction,” said Dr. Armstrong.
Among other topics to be addressed at the conference, Dr. Deresinski noted that the recent drop in Zika infections, as well as an uptick seen in hepatitis A outbreaks among the homeless and drug-user populations, would be discussed later in the week.
[email protected]
On Twitter @eaztweets
AT IDWEEK 2017
High percentage of nursing home residents found to harbor MDROs
SAN DIEGO – Nearly half of nursing home residents harbored multi-drug resistant organisms on their skin, results from a large multi-center surveillance study showed.
“Residents in skilled nursing homes are the most vulnerable patients in the health care system,” lead study author James A. McKinnell, MD, said in an interview in advance of an annual scientific meeting on infectious diseases. “Many residents depend on help from health care workers for routine needs like eating or bathing. Skilled nursing facilities have an obligation to optimize the personal hygiene and environmental cleanliness in skilled nursing facilities.”
The researchers obtained 2,797 body swabs from 1,400 residents in all. Swabs were processed for methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococcus spp. (VRE), extended spectrum beta-lactamase producers (ESBLs), and carbapenem-resistant Enterobacteriaceae (CRE). “MRSA is a relatively well known bacteria, but CRE is the new pathogen that the CDC has defined as an urgent public health threat,” Dr. McKinnell said.
The researchers also conducted environmental surveillance of commonly touched items in skilled nursing facilities. The five surfaces tested in resident rooms were the bedside table, TV remote, door knobs, light switch, and bathrooms. The five surfaces tested in common areas were the nursing station counter, tables, chairs, hallway hand rails, and drinking fountains.
Overall, 49% of residents harbored MDROs. MRSA was found in 37% of residents, followed by ESBL in 16%, VRE in 7%, and CRE in 1%. Resident MDRO status was known for 11% of MRSA carriers, compared with 18% of ESBL, 4% of VRE, and none of the CRE carriers. Rates of colonization did not differ whether residents had long stays at the facility or postacute stays (49% vs. 48%, respectively), but bed-bound residents were more likely to be MDRO colonized, compared with ambulatory residents (59% vs. 46%; P less than .001). In the analysis of environmental swabs, 93% of common areas and 74% of resident rooms had an MDRO-positive object, with an average of 2.5 and 1.9 objects, respectively, found to be contaminated.
“The fact that about half of patients were carrying a bacteria that could cause infection on their skin was very high,” said Dr. McKinnell, who is a member of the Infectious Disease Clinical Outcome Research Unit at the Los Angeles Biomedical Research Institute at Harbor-UCLA. “Studies conducted in other care settings, we would typically see less than a quarter of patients carry these types of bacteria. I was also surprised to see that 1% of patients were carrying the CRE bacteria on their skin.”
He acknowledged certain limitations of the study, including the fact that the data were taken from a select group of nursing homes that are participating in an interventional study to improve personal hygiene for skilled nursing facility residents. “They may not be representative of all skilled nursing facilities,” he said.
The Agency for Healthcare Research and Quality funded the study. Dr. McKinnell disclosed that he is conducting studies in health care facilities with products supplied from 3M, Clorox, Sage, and Xttrium Laboratories. Many of his coauthors disclosed numerous financial ties to the pharmaceutical industry. The event was 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 – Nearly half of nursing home residents harbored multi-drug resistant organisms on their skin, results from a large multi-center surveillance study showed.
“Residents in skilled nursing homes are the most vulnerable patients in the health care system,” lead study author James A. McKinnell, MD, said in an interview in advance of an annual scientific meeting on infectious diseases. “Many residents depend on help from health care workers for routine needs like eating or bathing. Skilled nursing facilities have an obligation to optimize the personal hygiene and environmental cleanliness in skilled nursing facilities.”
The researchers obtained 2,797 body swabs from 1,400 residents in all. Swabs were processed for methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococcus spp. (VRE), extended spectrum beta-lactamase producers (ESBLs), and carbapenem-resistant Enterobacteriaceae (CRE). “MRSA is a relatively well known bacteria, but CRE is the new pathogen that the CDC has defined as an urgent public health threat,” Dr. McKinnell said.
The researchers also conducted environmental surveillance of commonly touched items in skilled nursing facilities. The five surfaces tested in resident rooms were the bedside table, TV remote, door knobs, light switch, and bathrooms. The five surfaces tested in common areas were the nursing station counter, tables, chairs, hallway hand rails, and drinking fountains.
Overall, 49% of residents harbored MDROs. MRSA was found in 37% of residents, followed by ESBL in 16%, VRE in 7%, and CRE in 1%. Resident MDRO status was known for 11% of MRSA carriers, compared with 18% of ESBL, 4% of VRE, and none of the CRE carriers. Rates of colonization did not differ whether residents had long stays at the facility or postacute stays (49% vs. 48%, respectively), but bed-bound residents were more likely to be MDRO colonized, compared with ambulatory residents (59% vs. 46%; P less than .001). In the analysis of environmental swabs, 93% of common areas and 74% of resident rooms had an MDRO-positive object, with an average of 2.5 and 1.9 objects, respectively, found to be contaminated.
“The fact that about half of patients were carrying a bacteria that could cause infection on their skin was very high,” said Dr. McKinnell, who is a member of the Infectious Disease Clinical Outcome Research Unit at the Los Angeles Biomedical Research Institute at Harbor-UCLA. “Studies conducted in other care settings, we would typically see less than a quarter of patients carry these types of bacteria. I was also surprised to see that 1% of patients were carrying the CRE bacteria on their skin.”
He acknowledged certain limitations of the study, including the fact that the data were taken from a select group of nursing homes that are participating in an interventional study to improve personal hygiene for skilled nursing facility residents. “They may not be representative of all skilled nursing facilities,” he said.
The Agency for Healthcare Research and Quality funded the study. Dr. McKinnell disclosed that he is conducting studies in health care facilities with products supplied from 3M, Clorox, Sage, and Xttrium Laboratories. Many of his coauthors disclosed numerous financial ties to the pharmaceutical industry. The event was 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 – Nearly half of nursing home residents harbored multi-drug resistant organisms on their skin, results from a large multi-center surveillance study showed.
“Residents in skilled nursing homes are the most vulnerable patients in the health care system,” lead study author James A. McKinnell, MD, said in an interview in advance of an annual scientific meeting on infectious diseases. “Many residents depend on help from health care workers for routine needs like eating or bathing. Skilled nursing facilities have an obligation to optimize the personal hygiene and environmental cleanliness in skilled nursing facilities.”
The researchers obtained 2,797 body swabs from 1,400 residents in all. Swabs were processed for methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococcus spp. (VRE), extended spectrum beta-lactamase producers (ESBLs), and carbapenem-resistant Enterobacteriaceae (CRE). “MRSA is a relatively well known bacteria, but CRE is the new pathogen that the CDC has defined as an urgent public health threat,” Dr. McKinnell said.
The researchers also conducted environmental surveillance of commonly touched items in skilled nursing facilities. The five surfaces tested in resident rooms were the bedside table, TV remote, door knobs, light switch, and bathrooms. The five surfaces tested in common areas were the nursing station counter, tables, chairs, hallway hand rails, and drinking fountains.
Overall, 49% of residents harbored MDROs. MRSA was found in 37% of residents, followed by ESBL in 16%, VRE in 7%, and CRE in 1%. Resident MDRO status was known for 11% of MRSA carriers, compared with 18% of ESBL, 4% of VRE, and none of the CRE carriers. Rates of colonization did not differ whether residents had long stays at the facility or postacute stays (49% vs. 48%, respectively), but bed-bound residents were more likely to be MDRO colonized, compared with ambulatory residents (59% vs. 46%; P less than .001). In the analysis of environmental swabs, 93% of common areas and 74% of resident rooms had an MDRO-positive object, with an average of 2.5 and 1.9 objects, respectively, found to be contaminated.
“The fact that about half of patients were carrying a bacteria that could cause infection on their skin was very high,” said Dr. McKinnell, who is a member of the Infectious Disease Clinical Outcome Research Unit at the Los Angeles Biomedical Research Institute at Harbor-UCLA. “Studies conducted in other care settings, we would typically see less than a quarter of patients carry these types of bacteria. I was also surprised to see that 1% of patients were carrying the CRE bacteria on their skin.”
He acknowledged certain limitations of the study, including the fact that the data were taken from a select group of nursing homes that are participating in an interventional study to improve personal hygiene for skilled nursing facility residents. “They may not be representative of all skilled nursing facilities,” he said.
The Agency for Healthcare Research and Quality funded the study. Dr. McKinnell disclosed that he is conducting studies in health care facilities with products supplied from 3M, Clorox, Sage, and Xttrium Laboratories. Many of his coauthors disclosed numerous financial ties to the pharmaceutical industry. The event was 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 ID WEEK 2017
Key clinical point: About one of every two nursing home residents is colonized with multidrug resistant organisms.
Major finding:
Study details: A surveillance study of 1,400 residents at 28 skilled nursing facilities in Southern California.
Disclosures: The Agency for Healthcare Research and Quality funded the study. Dr. McKinnell disclosed that he is conducting studies in health care facilities with products supplied from 3M, Clorox, Sage, and Xttrium Laboratories. Many of his coauthors disclosed numerous financial ties to the pharmaceutical industry.
IDWeek 2017 opens in San Diego
facing infectious diseases clinicians and researchers in the 21st century.
Premeeting workshops and symposia occupy most of the first 2 days of the event, with highlights including a session on managing infections in opioid users and a “late breaker” symposium addressing the latest on the H7N9 outbreak in China, the current findings and recommendations regarding Candida auris, and the epidemiology of the recent Legionella outbreaks in the United States. Another late breaker session focuses on the recent spate of hepatitis A outbreaks, including one in conference host city San Diego, primarily among the homeless population.
IDWeek is the combined annual meeting of the Infectious Diseases Society of America (IDSA), the Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA), and the Pediatric Infectious Diseases Society (PIDS). The first IDWeek was held in 2012.
One intriguing interactive session – aptly-titled “Nightmare Bugs” – will investigate the problems posed by multidrug-resistant organisms and the need for new antimicrobials to defeat them.
There are many sessions and posters addressing evergreen clinical topics for ID clinicians, such as antimicrobial resistance, antibiotic stewardship, surgical site infections, bacteremia and sepsis, Clostridium difficile, hepatitis care, and HIV care. But the education committee at IDWeek always manages to touch on topics in the news. For instance, one late breaker session will feature a discussion of the nexus between the opioid crisis and infectious diseases, the outbreak of cholera in Yemen, and the epidemiology of the yellow fever outbreak in Brazil.
Featured speakers at the event include James M. Hughes, MD, professor of medicine at Emory University, Atlanta, who will discuss the importance of a One Health approach to emerging microbial threats, and Connie Celum, MD, MPH, professor of global health and medicine, University of Washington, Seattle, who intends to describe the progress in effective HIV prevention interventions and lessons learned in implementation. Neil O. Fishman, MD, of the University of Pennsylvania Perelman School of Medicine, is delivering the annual SHEA lecture at IDWeek, and will explain how ID physicians and epidemiologists can promote interventions to achieve high reliability in health care. Renowned ID researcher Janet Englund, MD, of Seattle Children’s Hospital, will discuss the potential future therapies to prevent or treat respiratory viral infections in high-risk pediatric patients.
The 2017 conference will close with a three-part plenary – “21st Century Cures” – featuring ID luminaries Christopher Karp, MD, of the Bill & Melinda Gates Foundation, James E. Crowe Jr., MD, of Vanderbilt University Medical Center in Nashville, Tenn., and David Thomas, MD, MPH, of Johns Hopkins University in Baltimore.
[email protected]
On Twitter @richpizzi
facing infectious diseases clinicians and researchers in the 21st century.
Premeeting workshops and symposia occupy most of the first 2 days of the event, with highlights including a session on managing infections in opioid users and a “late breaker” symposium addressing the latest on the H7N9 outbreak in China, the current findings and recommendations regarding Candida auris, and the epidemiology of the recent Legionella outbreaks in the United States. Another late breaker session focuses on the recent spate of hepatitis A outbreaks, including one in conference host city San Diego, primarily among the homeless population.
IDWeek is the combined annual meeting of the Infectious Diseases Society of America (IDSA), the Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA), and the Pediatric Infectious Diseases Society (PIDS). The first IDWeek was held in 2012.
One intriguing interactive session – aptly-titled “Nightmare Bugs” – will investigate the problems posed by multidrug-resistant organisms and the need for new antimicrobials to defeat them.
There are many sessions and posters addressing evergreen clinical topics for ID clinicians, such as antimicrobial resistance, antibiotic stewardship, surgical site infections, bacteremia and sepsis, Clostridium difficile, hepatitis care, and HIV care. But the education committee at IDWeek always manages to touch on topics in the news. For instance, one late breaker session will feature a discussion of the nexus between the opioid crisis and infectious diseases, the outbreak of cholera in Yemen, and the epidemiology of the yellow fever outbreak in Brazil.
Featured speakers at the event include James M. Hughes, MD, professor of medicine at Emory University, Atlanta, who will discuss the importance of a One Health approach to emerging microbial threats, and Connie Celum, MD, MPH, professor of global health and medicine, University of Washington, Seattle, who intends to describe the progress in effective HIV prevention interventions and lessons learned in implementation. Neil O. Fishman, MD, of the University of Pennsylvania Perelman School of Medicine, is delivering the annual SHEA lecture at IDWeek, and will explain how ID physicians and epidemiologists can promote interventions to achieve high reliability in health care. Renowned ID researcher Janet Englund, MD, of Seattle Children’s Hospital, will discuss the potential future therapies to prevent or treat respiratory viral infections in high-risk pediatric patients.
The 2017 conference will close with a three-part plenary – “21st Century Cures” – featuring ID luminaries Christopher Karp, MD, of the Bill & Melinda Gates Foundation, James E. Crowe Jr., MD, of Vanderbilt University Medical Center in Nashville, Tenn., and David Thomas, MD, MPH, of Johns Hopkins University in Baltimore.
[email protected]
On Twitter @richpizzi
facing infectious diseases clinicians and researchers in the 21st century.
Premeeting workshops and symposia occupy most of the first 2 days of the event, with highlights including a session on managing infections in opioid users and a “late breaker” symposium addressing the latest on the H7N9 outbreak in China, the current findings and recommendations regarding Candida auris, and the epidemiology of the recent Legionella outbreaks in the United States. Another late breaker session focuses on the recent spate of hepatitis A outbreaks, including one in conference host city San Diego, primarily among the homeless population.
IDWeek is the combined annual meeting of the Infectious Diseases Society of America (IDSA), the Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA), and the Pediatric Infectious Diseases Society (PIDS). The first IDWeek was held in 2012.
One intriguing interactive session – aptly-titled “Nightmare Bugs” – will investigate the problems posed by multidrug-resistant organisms and the need for new antimicrobials to defeat them.
There are many sessions and posters addressing evergreen clinical topics for ID clinicians, such as antimicrobial resistance, antibiotic stewardship, surgical site infections, bacteremia and sepsis, Clostridium difficile, hepatitis care, and HIV care. But the education committee at IDWeek always manages to touch on topics in the news. For instance, one late breaker session will feature a discussion of the nexus between the opioid crisis and infectious diseases, the outbreak of cholera in Yemen, and the epidemiology of the yellow fever outbreak in Brazil.
Featured speakers at the event include James M. Hughes, MD, professor of medicine at Emory University, Atlanta, who will discuss the importance of a One Health approach to emerging microbial threats, and Connie Celum, MD, MPH, professor of global health and medicine, University of Washington, Seattle, who intends to describe the progress in effective HIV prevention interventions and lessons learned in implementation. Neil O. Fishman, MD, of the University of Pennsylvania Perelman School of Medicine, is delivering the annual SHEA lecture at IDWeek, and will explain how ID physicians and epidemiologists can promote interventions to achieve high reliability in health care. Renowned ID researcher Janet Englund, MD, of Seattle Children’s Hospital, will discuss the potential future therapies to prevent or treat respiratory viral infections in high-risk pediatric patients.
The 2017 conference will close with a three-part plenary – “21st Century Cures” – featuring ID luminaries Christopher Karp, MD, of the Bill & Melinda Gates Foundation, James E. Crowe Jr., MD, of Vanderbilt University Medical Center in Nashville, Tenn., and David Thomas, MD, MPH, of Johns Hopkins University in Baltimore.
[email protected]
On Twitter @richpizzi