Stewardship / Resistance Scan for Aug 30, 2019

Stewardship / Resistance Scan for Aug 30, 2019 Jim Wappes Fri, 08/30/2019 - 15:27 Bullet points Infection-linked pancreatic scopes Oral antibiotic for skin infections Resistant enterococci in Germany Body FDA urges hospitals to start using duodenoscopes with disposable parts The US Food and Drug Administration (FDA) says it will now recommend that hospitals move away from using duodenoscopes with reusable parts because of concerns about patient infections that have been linked to cleaning issues. In a safety communication issued yesterday, the FDA said it's recommending that hospitals and endoscopy facilities transition away from fixed endcap duodenoscopes, which are used to diagnose and treat conditions of the pancreas and bile ducts, to those with newer design features that "facilitate or eliminate the need for reprocessing." The agency says it's working with manufacturers to increase the supply of disposable cap duodenoscopes and encourage development of innovative device designs that reduce the risk of infection, and that it recognizes a full transition away from conventional duodenoscopes will take time. Fixed endcap duodenoscopes have been linked to a number of outbreaks of multidrug-resistant bacteria at US and European hospitals in recent years, including a January 2015 carbapenem-resistant Enterobacteriaceae outbreak that resulted in two deaths at a Los Angeles hospital. Because of the complex design of the devices, they can be difficult to clean and have been found to harbor dangerous bacteria that can be transmitted to other patients, even after being properly cleaned. The FDA issued a safety warning in 2015 and device manufacturers updated their cleaning instructions, but problems have persisted. Duodenoscopes are used in more than 500,000 endoscopic retrograde cholangiopancreatography procedures each year in the United States. The FDA said that, during the transition period, hospitals and endoscopy facilities should ensure that staff members are meticulously following duodenoscope reprocessing instructions, institute quality control programs that include sampling and microbiologic culturing, and develop schedules for routine inspection. The agency also noted that patients should be aware that the risk of infection from inadequate cleaning is relatively low, and that they should discuss the risks and benefits with their providers before cancelling or delaying planned procedures. Aug 29 FDA safety communication Oral omadacycline found non-inferior to linezolid for skin infections Drug maker Paratek Pharmaceuticals reported yesterday in The Lancet Infectious Diseases that and oral version of omadacycline—its FDA-approved antibiotic for community-acquired and pneumonia and skin infections—was found to be non-inferior to oral linezolid in adults with acute bacterial skin and skin-structure infection (ABSSSI). In the phase 3 OASIS 2 trial, which was funded by Paratek, eligible adults with ABSSSI at 33 US hospitals were randomly assigned to receive one dose of oral omadacycline or two doses of linezolid for 7 to 14 days. The primary end points were early clinical response (48 to 72 hours after the first dose) in the modified intention-to-treat (mITT) population, and investigator-assessed clinical response at post-treatment evaluation in the mITT population and clinically evaluable population. The non-inferiority margin was 10%. Overall, 735 participants were randomly assigned, with 368 receiving omadacycline and 367 receiving linezolid. The results showed that omadacycline (315 of 360, 88%) was non-inferior to linezolid (297 of 360, 83%) for early clinical response in the mITT population (percentage-point difference 5.0; 95% confidence interval [CI], −0.2 to 10.3). For investigator-assessed clinical response at post-treatment evaluation, omadacycline (303 of 360, 84%) was non-inferior to linezolid (291 of 360 81%) in the mITT population (percentage-point difference 3.3; 95% CI, −2.2 to 9.0) and in the clinically evaluable population (278 of 284 [98%] vs 279 of 292 [96%]; percentage-point difference, 2.3; 95% CI, −0.5 to 5.8). The safety analysis showed that at least one treatment-emergent adverse event occurred in 197 of 368 omadacycline patients (54%), compared with 137 of 367 linezolid patients (37%), and that mild-to-moderate nausea and vomiting were more frequent in omadacycline patients (111 of 368 [30%] and 62 of 368 [17%], respectively) than in linezolid patients (28 of 367 [8%] and 11 of 367 [3%], respectively). The authors of the study write, "Considering the substantial burdens associated with initial inpatient management of skin infections, oral omadacycline is a new once-daily option to treat ABSSSI that might be considered as an alternative to linezolid." Aug 29 Lancet Infect Dis study Data show vancomycin-resistant Enterococcus faecium rising in Germany Data from the German Antimicrobial Resistance Surveillance System show a 43% increase in vancomycin-resistant Enterococcus faecium (VREF) in German hospitals, according to a new study in Antimicrobial Resistance and Infection Control. For the study, researchers from Germany's Robert Koch Institute analyzed data from routine vancomycin susceptibility testing of 35,906 clinical E faecium isolates collected from 148 hospitals from 2012 through 2017. The analysis found that the proportions of E faecium isolates exhibiting resistance to vancomycin increased from 11.2% in 2014 to 26.2% in 2017. The rise in VREF proportions was primarily seen in southern Germany, increasing from 10.8% in southwest Germany and 3.8% in southeastern Germany in 2014 to 36.7% and 36.8% in 2017, respectively. Further analysis found that VREF proportions were considerably higher in isolates from patients aged 40 to 59 years compared with younger patients, and that E faecium samples collected in specialist care hospitals and prevention and rehabilitation care hospitals were more likely to be vancomycin resistant than those from secondary care hospitals (odds ratios: 2.4 [95% CI, 1.2 to 4.6] and 2.4 [95% CI, 1.9 to 3.0], respectively). The authors of the study note that similar VREF increases have been found in countries neighboring Germany, including Denmark, Belgium, Poland, and the Czech Republic. They conclude, "Continued surveillance and implementation of effective infection prevention and control measures accounting for local resistance differences are needed to reduce the spread of vancomycin-resistant E. faecium in German hospitals." Aug 28 Antimicrob Resist Infect Control study Infectious disease topic Antimicrobial Stewardship Date Fri, 08/30/2019 - 09:00