Our weekly wrap-up of antimicrobial stewardship & antimicrobial resistance scans
New WHO documents focus on tailored antimicrobial stewardship
The World Health Organization (WHO) this week release three new documents that aim to address antimicrobial resistance (AMR) through a behavioral insights approach.
The documents are based on the Tailoring Antimicrobial Resistance Programmes (TAP) approach, which aims to help stakeholders develop targeted stewardship interventions that are tailored toward the needs of specific groups (such as prescribers, pharmacists, patients, and veterinarians) and contexts (communities, pharmacies, and hospitals).
The TAP Quick Guide is a “how to” for rapid and practical application of the TAP approach, while the TAP Toolbox contains tools and templates for each stage of the approach. The TAP Process poster provides a visual description of the step-by-step approach to designing and implementing TAP interventions. A fourth document, the TAP Manual, will be published at the end of the year.
“These new tools offer practical actions and measures to stop the spread of AMR, which is essential to saving lives and ensuring the continued usefulness of antibiotics, and is part of being responsible and effective practitioners and consumers,” Nino Berdzuli, MD, MPH, director of the WHO’s Division of Country Health Programmes, said in a press release from the WHO Regional Office for Europe.
The WHO says TAP pilot projects are under way in several European region countries, including the United Kingdom, Sweden, Hungary, North Macedonia, and Kazakhstan.
Jun 10 WHO/Europe press release
UK group reports decline in antibiotic use in pigs
A report yesterday from the UK Agriculture and Horticulture Development Board (AHDB) shows that antibiotic use by UK pig farmers declined last year, bringing the total reduction since 2015 to 62%.
Using data from the electronic Medicines book (eMb), which cover 95% of slaughter pigs in the United Kingdom, the report found that total antibiotic usage in pigs fell 5% from 2019 levels, from 110 milligrams (mg) per population correction unit (PCU) to 105 mg/PCU. The use of highest-priority critically important antibiotics saw a slight increase (from 0.04 mg/PCU to 0.052 mg/PCU), but overall it remains at very low levels. No use of colistin, a last-resort antibiotic for multidrug-resistant infections in humans, was reported in 2020.
ADHB officials say the decline brings the UK pig industry close to the target level of 99 mg/PCU, set in 2015.
“The sector has delivered sustained reductions since recording began via eMB in 2015,” AHDB Sector Strategy Director for Pork Angela Christison said in an AHDB press release. “This continued improvement, despite disruption to pig flow during the pandemic, is a credit to collaboration between producers, vets and the industry as a whole.”
FDA finalizes guidance for topical, injectable antibiotics used in animals
Originally published by CIDRAP News Jun 10
The Food and Drug Administration (FDA) announced today that it has finalized guidelines to bring the remaining medically important antibiotics still sold over-the-counter (OTC) for use in animals under the supervision of veterinarians.
The finalization of guidance for industry (GFI) #263 means that the roughly 4% of medically important antibiotics that are currently marketed as OTC products for use in livestock and companion animals will require a prescription from a licensed veterinarian going forward. It builds on previous FDA guidance (GFI #213), which brought 96% of all medically important antibiotics used in animal water and feed under veterinary supervision and limited their use to treatment, control, or prevention of specific diseases.
The remaining 4% of medically important antibiotics not covered by GFI #213 include other dosage forms, such as injectables and topicals. The new guidance outlines the process for animal drug sponsors to voluntarily change the labels on these products from OTC to prescription.
The FDA says the new guidelines will be implemented over a 2-year timeframe.
“The agency is committed to working with affected stakeholders to facilitate the transition process and to minimize impacts on animal health,” the agency said in a press release. “During the two-year timeframe for implementation recommended in GFI #263, FDA plans to work with affected stakeholders and state partners to answer questions about the voluntary transition process and provide assistance where possible.”
Jun 10 FDA press release
BARDA grants additional funding for rapid antibiotic susceptibility test
Originally published by CIDRAP News Jun 10
Selux Diagnostics announced this week that it has been awarded an additional $14.6 million in funding from the Biomedical Advanced Research and Development Authority (BARDA) to commercialize its Next Generation Phenotyping (NGP) platform for rapid antibiotic susceptibility testing (AST).
BARDA granted the additional funding after Selux completed its first clinical trial, which confirmed the NGP platform’s ability to provide rapid, accurate AST results for a wide array of antibiotics from cultured isolates. Selux plans to submit the clinical results to the FDA to begin the process of commercialization.
BARDA has now awarded a total of $60.8 million to Selux to support the project.
“A global crisis of antibiotic resistance requires innovation to save lives, and we believe this next generation technology represents the future backbone of microbiology,” Selux CEO Steve Lufkin said in a company press release. “Our plan is to build on the success of this first clinical study and turn our attention to the next phase of product development to speed the time to targeted antibiotic treatment further, preserving the lifesaving power of antibiotics for future generations.”
Jun 8 Selux press release
CARB-X to fund development of rapid diagnostic test for sepsis
Originally published by CIDRAP News Jun 8
CARB-X announced today that is awarding Tucson, Arizona–based Accelerate Diagnostics $578,000 to develop a diagnostic test for sepsis based on new fiber optic technology.
The award will help the company develop a compact instrument that uses Stimulated Raman Spectroscopy to identify bacteria from positive blood culture with minimal sample processing within 15 minutes. The technology, which is currently in the feasibility phase of development, has demonstrated high sensitivity and specificity and the ability to identify a wide range of bacterial pathogens.
Sepsis, which is the body’s overwhelming and life-threatening reaction to an infection, causes an estimated 11 million deaths each year. Quick diagnosis of the causative pathogen is considered critical for appropriate treatment.
Accelerate would be eligible for up $2.1 million in additional funds from CARB-X (the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator) if the project meets certain milestones.
“Prompt diagnosis and treatment provide the best chance for reducing death rates and improving recovery from sepsis,” CARB-X Research and Development Chief Erin Duffy, PhD, said in a CARB-X press release. “Accelerate’s technology aims to speed up delivery of diagnostic test results which would help clinicians make treatment decisions in the first critical hours of illness.”
Since its launch in 2016, CARB-X has awarded more than $480 million in funding to support the development of antibiotics, vaccines, diagnostics, and other products focused on antibiotic-resistant bacteria.
Jun 8 CARB-X press release
GARDP announces funding from Japan for antibiotic development
Originally published by CIDRAP News Jun 8
The Global Antibiotic Research and Development Partnership (GARDP) announced yesterday that it has received additional funding from the Japanese government to support its efforts to fight antibiotic-resistant infections.
The 200 million yen (US $1.8 million) investment by the government of Japan, the second payment of a 1 billion yen (US $9 million) pledge to GARDP over 5 years, will be used to accelerate research and development into treatments for the antibiotic-resistant “priority pathogens” identified by the WHO, and ensure that these treatments are used responsibly and are accessible to all who need them. The funding covers the period April 2021 to March 2002
“We would like to express our gratitude to the Government of Japan, through the Ministry of Health, Labour and Welfare, for its ongoing support and commitment to addressing the silent pandemic of drug-resistant infections,” GARDP Executive Director Manica Balasegaram, MRCP, MSc, said in a press release. “This funding signals Japan’s leadership in global health, and recognition that achieving the UN Sustainable Development Goals will require urgent action to deliver effective antibiotics, available for every person who needs them.”
Jun 7 GARDP press release
Trial of rapid respiratory tests finds no reduction in antibiotics
Originally published by CIDRAP News Jun 7
The use of rapid respiratory pathogen (RRP) testing among children with influenza-like illness (ILI) did not reduce antibiotic prescribing, according to a randomized clinical trial published late last week in JAMA Network Open.
The single-center trial, conducted by investigators with the University of Colorado School of Medicine and Children’s Hospital Colorado, involved children aged 1 month to 18 years who presented to the emergency department with ILI from Dec 1, 2018, to Nov 30, 2019. All children received a nasopharyngeal swab for RRP testing and were randomized 1:1 to an intervention group, in which the emergency department (ED) clinician and families of children received test results, and a control group that did not. The primary outcome was antibiotic prescribing during the ED visit. Secondary outcomes included antiviral prescribing, ED length of stay, and hospital admission.
The cohort consisted of 908 children, with 452 in the intervention group and 456 in the control group. The median age was 2.1 years, and there were no significant differences in demographic and clinical characteristics between the two groups. Positive RRP test results were obtained for 795 of 931 visits (85%). The most common pathogens were enterovirus (n=295), influenza (180), respiratory syncytial virus (162), and adenovirus (115).
In the intention-to-treat (ITT) intervention group, children were more likely to receive antibiotics (relative risk [RR], 1.3; 95% confidence interval [CI], 1.0 to 1.7), with no significant differences in antiviral prescribing, medical visits, and hospitalization. In a modified ITT analysis, children whose clinician knew the RRP test results were more likely to receive antivirals (RR, 2.6; 95% CI, 1.6 to 4.5) and be hospitalized (RR, 1.8; 95% CI, 1.4 to 2.5) than those whose clinicians did not know the test results, but antibiotic prescribing was not significantly different (RR, 1.1; 95% 0.9 to 1.4).
“The results of this randomized clinical trial show that RRP testing for children with acute respiratory illnesses in an ED setting did not lead to a decrease in antibiotic prescribing,” the study authors wrote. “The greatest effect on clinicians’ clinical decision-making was appropriate antiviral use for children based on influenza test results, supporting the potential benefit for rapid molecular influenza testing in this setting.”
Jun 4 JAMA Netw Open study