ASP Scan (Weekly) for Dec 06, 2019

European priority pathogen surveillance
US hospital stewardship
MRSA screening test ok'd
New CARB-X funding
Delafloxacin for pneumonia
Non–beta-lactam allergy testing
Antibiotic review at discharge

Our weekly wrap-up of antimicrobial stewardship & antimicrobial resistance scans

Study: Mandatory surveillance of priority pathogens lacking in Europe

A review of national documents shows that fewer than half of European countries have implemented publicly accessible mandatory surveillance of at least one of the World Health Organization's (WHO's) priority pathogens, European researchers reported yesterday in Clinical Microbiology and Infection.

The review found that of 28 European Union and 4 European Free Trade Association member states, 21 (66%) had a national mandate to survey at least one of the WHO's critical- and high-priority antibiotic-resistant pathogens, but only 15 (47%) had publicly accessible information that could be evaluated. The most frequently monitored pathogens were carbapenem-resistant Enterobacteriaceae (12, 38%), methicillin-resistant Staphylococcus aureus (12, 38%), and vancomycin-resistant Enterococci (8, 25%).  No countries required reporting of resistance in Salmonella, Campylobacter, Helicobacter pylori, and Neisseria gonorrhea.

The reviewers also found significant differences in the type of data collected and disseminated by the 15 mandatory surveillance systems. Those differences included heterogeneous definition of clinical samples, screening, and type of specimen included. Only half of the systems collected data on clinical outcomes, patient-based risk factors, and resistance mechanism. In addition, only 9 (28%) countries had mandatory reporting of outbreaks caused by WHO priority pathogens, of which 6 provided public access and 1 provided weekly numbers.

The authors of the study say that rising antimicrobial resistance (AMR), and the growing risk of spreading resistant pathogens through travel and transfer of hospital patients among countries, underscores the need to improve mandatory surveillance and standardize data collection and reporting.

"The results of this review should push forward the debate on mandatory surveillance for high priority antibiotic resistant bacteria and restructuring of current surveillance strategies at national level in Europe," the authors write. "Making surveillance protocols and results freely-accessibly is considered a pillar of the European AMR strategy and should be made an immediate priority."
Dec 5 Clin Microbiol Infect study


Stewardship, C diff prevention up in US hospitals, but ID expertise lags

A survey of US hospitals has found that while antibiotic stewardship programs and evidence-based Clostridioides difficile infection (CDI) prevention practices are now common, infectious disease (ID) expertise is limited, and fewer than half of hospitals meet accreditation standards for multidisciplinary stewardship teams.

In a paper published today in Infection Control and Hospital Epidemiology, researchers report that of 528 US hospitals that completed a 2017 survey on the presence and composition of antibiotic stewardship programs, current methods of CDI prevention and treatment, and diagnostic stewardship practices, 95% reported having an antibiotic stewardship program—up from 52% in 2013. In addition, the reported use of guideline-recommended CDI prevention practices was over 90%, with CDI prevention seen as "important" or "very important" to hospital leadership in 89% of hospitals.

However, the survey also found that antibiotic stewardship team members with ID training were less common: 52% of programs had an ID-trained pharmacist, 69% had an ID physician, and only 43% had both. Team members with ID training were more likely in larger hospitals. Furthermore, only 41% of hospitals met The Joint Commission's 2017 standards for accreditation, which require hospitals to have multidisciplinary antibiotic stewardship teams that include an ID physician, infection preventionist, pharmacist, and practitioner. And CDI prevention practices varied across hospitals, with less use of novel CDI practices and diagnostic stewardship strategies at smaller hospitals.

"Although nearly all hospitals now have an antibiotic stewardship program, team compositions differ by hospital size, and most hospitals do not meet ideal recommendations for multidisciplinary teams," the authors of the paper write. "Specifically, smaller hospitals appear to have limited ID expertise on their stewardship teams and to struggle with deploying diagnostic stewardship strategies."

The authors suggest that CDI prevention at smaller hospitals could be enhanced by emphasizing the role of generalists (including clinical pharmacists, nurses, and hospitalists) in antibiotic stewardship.
Dec 6 Infect Control Hosp Epidemiol abstract


FDA approves test that speeds MRSA screening

Originally published by CIDRAP News Dec 5

The US Food and Drug Administration (FDA) today approved a new test to diagnose methicillin-resistant Staphylococcus aureus (MRSA), which will allow health workers to screen patients for MRSA colonization more quickly—in as little as 5 hours compared with 24 to 48 hours for traditional culture-based tests.

The test, known as cobas vivoDx MRSA, is marketed by Roche Molecular Systems, Inc, of Pleasanton, California. According to an FDA news release, the test uses a new bacteriophage technology based on luminescence that can detect MRSA in nasal swabs. Data presented during the review process showed that the test correctly identified MRSA in about 90% of samples when MRSA was present and detected no MRSA in 98.6% of samples that did not contain the bacteria.

The FDA evaluated the test through its de novo premarket review pathway for new types of low-to-moderate risk devices. The agency said it is developing new types of controls for this type of test, which covers labeling and design verification and validation to address certain risks, such as false-positives. It said meeting those and general controls provides reasonable assurance and safety for these types of tests and that the actions create a new regulatory classification that subsequent devices will be measured against.

Tim Stenzel, PhD, MD, who directs the FDA's Office of In Vitro Diagnostics and Radiological Health in its Center for Devices and Radiological Health, said in the release, "Today's authorization adds a new tool in the fight to prevent and control MRSA in high-risk settings. The FDA remains committed to supporting efforts to address antimicrobial resistance in order to better protect patients against this ongoing public health challenge."
Dec 5 FDA press release


CARB-X announces funding for new microbiome therapy

Originally published by CIDRAP News Dec 5

The Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) today announced funding of up to $5.8 million for the development of an oral therapy designed to restore healthy gut bacteria and help fight infection and colonization with multidrug-resistant organisms (MDROs).

The award to Vedanta Biosciences, of Cambridge, Massachussets, will support development of VE707, the company's preclinical human microbiome program. VE707 consists of commensal, non-pathogenic bacterial strains and is designed to decolonize patients who have gut-dwelling MDROs and are at high risk of developing infections. The therapy is being specifically developed to eliminate intestinal carriage of carbapenem-resistant Enterobacteriaceae, extended-spectrum beta-lactamase producers, and vancomycin-resistant Enterococcus.

"If we could get rid of intestinal carriage of these MDROs in high risk patients, we could not only prevent infections, but also curb the transmission of these organisms and enable physicians to avoid using antibiotics that select for ever-more resistant bacterial strains," Vedanta CEO Bernat Olle, PhD, said in a CARB-X press release.

Vedanta could receive an additional $3.5 million in funding for VE707 from CARB-X if certain project milestones are met. 
Dec 5 CARB-X press release


Phase 3 trial demonstrates safety, efficacy of delafloxacin for pneumonia

Originally published by CIDRAP News Dec 5

The results of a phase 3 clinical trial comparing the efficacy and safety of delafloxacin to moxifloxacin for treating community-acquired bacterial pneumonia (CABP) appeared today in Open Forum Infectious Diseases.

In the randomized, multicenter trial, 859 CABP patients from study centers in 18 countries were assigned in a 1:1 ratio to receive either intravenous (IV)/oral delafloxacin or IV/oral moxifloxacin, with a primary end point of early clinical response—defined as 96 hours after the first dose of the study drug—in the intention-to-treat (ITT) population. Clinical response at test of cure (TOC) and microbiologic response at TOC were also assessed. The noninferiority margin was 12.5%.

The results showed that, in the ITT population, early clinical response rates were 88.9% in the delafloxacin group and 89.0% in the moxifloxacin, demonstrating noninferiority. Clinical success rates at microbiologic eradication at TOC were also similar between the two groups (90.5% for delafloxacin vs 89.7% for moxifloxacin), and data further showed that delafloxacin successfully eradicated key respiratory pathogens at rates comparable to moxifloxacin.

Treatment-emergent adverse events at least possibly related to the study drug occurred in 65 patients in the delafloxacin group (15.2%), compared with 54 in the moxifloxacin group (12.6%).

"With properties unique from other fluoroquinolones, delafloxacin monotherapy is effective and well-tolerated in the treatment of adults with CABP, providing coverage for gram-positive (including MRSA), gram-negative, and atypical pathogens commonly associated with CABP," trial investigators write.

The FDA's Oct 24 approval of delafloxacin for the treatment of patients with CABP was based on the trial results.
Dec 5 Open Forum Infect Dis abstract


Non–beta-lactam allergy not nearly as common as reported, study finds

Originally published by CIDRAP News Dec 3

A study of Australian children has found that only 1 in 5 with a reported non–beta-lactam antibiotic (NBLA) allergy had a true allergy, Australian researchers reported today in Pediatrics.

The retrospective study looked at children ages 0 to 18 at a tertiary pediatric hospital in Melbourne who had a suspected NBLA allergy and who had a skin test or intravenous or oral challenge test from May 2011 through June 2018. Over the course of the 7-year study period, 141 children had 150 evaluations of 15 different NBLAs, with a median time from the initial reported reaction to allergy evaluation of 1.9 years.

Overall, 27 of the 150 challenge results for NBLAs (18%) were positive. The frequency of reported reactions was highest for trimethoprim-sulfamethoxazole (15 of 46, 32.6%) and macrolides (8 of 77, 10.4%). Of the challenges that had positive results, most (23 of 27, 85.2%) had symptoms on repeat challenge that were similar to those initially reported. Four children reported initial anaphylactic reactions, but none had severe reactions on re-challenge or required adrenaline.

The authors of the study say the findings indicate that 80% of children with a reported NBLA allergy could be de-labeled, which could help preserve first-line antibiotics for these patients. They also note that while the median time to allergy evaluation was 1.9 years, delay in confirmation or exclusion of an NBLA allergy extended up to 14.9 years. They recommend that testing should occur promptly after an initial reaction.

"Improved access to standardized and reliable allergy testing protocols to delabel children are urgently needed," they conclude.
Dec 3 Pediatrics abstract


Study touts benefits of reviewing antibiotics for discharged patients

Originally published by CIDRAP News Dec 3

A single-center study in Infection Control and Hospital Epidemiology highlights discharge antibiotic review as a potential stewardship tool.

The study examined a 19-month period (June 2017 to December 2018) during which the antibiotic stewardship team at an 87-bed Veterans' Affairs hospital in Wisconsin reviewed the electronic health records of patients discharged from the hospital with oral antibiotics for appropriateness of antibiotic drug choice, duration, and dosing.

Because of limited resources, reviews were conducted only twice weekly, sometimes 3 to 4 days after patients had been discharged. Interventions recommended by the stewardship team included antibiotic discontinuation; change of antibiotic, dose, or duration; and diagnostic testing. Verbal and/or written recommendations were made to the prescribing service and, in some cases, the pharmacist.

Overall, 929 patients were discharged with antibiotics during the study period, and the stewardship team suggested changes in 90 prescriptions (9.7%). The most common reasons for intervention were antibiotic not indicated (43.3%), incorrect duration of therapy (24.4%), and preferred alternate antibiotic could have been chosen (23.3%). In 52 of the 90 interventions, the intervention was unable to be acted upon because the antibiotic course had already been completed; of the remaining 38 interventions, 22 (57.9%) were accepted by providers.

Common disease states intervened upon were chronic obstructive pulmonary disease (COPD, 24.4%), urinary tract infection (UTI, 18.8%), pneumonia (15.5%), and skin and other soft-tissue infection (SSTI, 15.5%).

The authors of the study note that while prescribers appeared to welcome feedback and suggestions on prescribing, the low acceptance rate could indicate increased barriers to intervention that are unique to discharged patients. Going forward, they suggest that focusing discharge stewardship interventions on common conditions like COPD, UTI, pneumonia, and SSTI may increase review efficiency, and that performing reviews prior to discharge could have a greater impact on patient care.
Nov 29 Infect Control Hosp Epidemiol abstract

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