Our weekly wrap-up of antimicrobial stewardship & antimicrobial resistance scans
FDA approves fecal microbiota product for recurrent C difficile
Originally published by CIDRAP News Dec 1
The US Food and Drug Administration (FDA) announced yesterday that it has approved a fecal microbiota product for the prevention of recurrent Clostridioides difficile infection (CDI) in adults.
Approval of Rebyota, which was developed by Swiss biopharmaceutical company Ferring Pharmaceuticals, was based on analysis of multiple randomized clinical trials. The efficacy analysis found that the overall estimated rate of success in preventing recurrent CDI through 8 weeks was significantly higher in the Rebyota group (70.6%) than in the placebo group (57.5%), while safety analysis found there were no serious treatment-related adverse events. The most common side effects after one dose of Rebyota were abdominal pain, diarrhea, abdominal bloating, gas, and nausea.
CDI—which occurs when C difficile bacteria multiply in the gut and release toxins, typically following antibiotic use—is a leading cause of hospital-acquired diarrhea and causes an estimated 500,000 and 29,000 deaths in the United States each year. Up to 35% of CDI cases recur after the initial episode, and patients who have recurrent infections have a significantly higher risk of further infection.
Prepared from stool donated by qualified individuals and delivered via enema, Rebyota is the first fecal microbiota product to be approved by the FDA. Fecal microbiota transplant therapy has been found in several studies to be an effective treatment for recurrent CDI compared with the standard of antibiotic therapy.
"Recurrent CDI impacts an individual's quality of life and can also potentially be life-threatening," Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research, said in an agency press release. "As the first FDA-approved fecal microbiota product, today's action represents an important milestone, as it provides an additional approved option to prevent recurrent CDI."
"We believe this is a major breakthrough in harnessing the power of the human microbiome to address significant unmet medical needs," Ferring President Per Falk, MD, PhD, said in a company press release.
Rebyota was approved for use in patients 18 years and older after they have completed antibiotic treatment for recurrent CDI.
EU global health strategy highlights antimicrobial resistance
Originally published by CIDRAP News Nov 30
A new document outlining the European Union (EU) global health strategy indicates that intensifying the fight against antimicrobial resistance (AMR) will be among the bloc's priorities.
Citing global health as an essential pillar of EU external policy—and AMR as a leading global health threat—the document, written by the European Commission's Directorate-General for Health and Food Safety, lists tackling AMR via a comprehensive, multisectoral, and transdisciplinary "One Health" approach as one of its guiding principles. The One Health framework views human, animal, plant, and environmental health as intrinsically linked, and encourages AMR mitigation efforts to address how antimicrobials are used in humans, animals, and plants.
To support this principle, the document recommends the EU intensify its work with the Quadripartite (the World Health Organization, the Food and Agriculture Agency of the United Nations [UN], the World Organization for Animal Health [WOAH], and the UN Environment Programme) to implement its One Health Joint Plan of Action, a 5-year program that seeks to improve the health of humans, animals, plants, and the environment while contributing to sustainable development.
It also calls on the EU to help build a robust global surveillance system to identify and address resistant bacteria and other zoonotic pathogens before they cross from animals to humans, to work towards the inclusion of concrete provisions on AMR in international pandemic agreements, and to support the development of and access to new antimicrobials, vaccines, and diagnostics.
"A quantum leap in health security will be achieved with a permanent mechanism that enhances equity in development of and access to tools such as vaccines, a global surveillance network which fully embodies One Health principles, and robust international rules, including enhanced measures to tackle anti-microbial resistance," the document states.
High rate of inappropriate antibiotic prescribing found in Chinese primary care
Originally published by CIDRAP News Nov 29
An analysis of outpatient antibiotic prescriptions from primary healthcare facilities (PHFs) in six Chinese provinces found that more than 70% were inappropriate, Chinese researchers reported last week in Clinical Microbiology and Infection.
In the nationwide survey of outpatient antibiotic prescriptions ordered from Chinese primary care facilities, researchers at Peking University collected data on all outpatient-visit prescriptions from 269 Chinese PHFs in 31 cities in six provinces from 2017 to 2019. They randomly selected 100 outpatient antibiotic prescriptions from each facility, then classified them as appropriate, potentially appropriate, and inappropriate based on the diagnosis for which they were prescribed. They also analyzed the type of antibiotics prescribed and the costs associated with inappropriate prescribing.
Of the 641,732 prescriptions analyzed, 209,662 (32.7%) included at least one antibiotic. Of those antibiotic prescriptions, 4.8% were classified as appropriate, 20.6% as potentially appropriate, and 70.5% as inappropriate. Upper respiratory tract infections, acute bronchitis, and non-infectious gastroenteritis were responsible for 68.9% of inappropriately antibiotic prescriptions. A total of 256,474 individual antibiotics were prescribed, of which 82.2% were broad-spectrum antibiotics, with second-generation cephalosporins (15.1%) and third-generation cephalosporins (14.6%) being the most commonly prescribed subgroups.
Higher inappropriate antibiotic prescribing rates were observed in children aged 0 to 5 years (78.5%) and patients living in economically undeveloped areas (77.5%). Cumulative spending on inappropriate antibiotics accounted for 66.8% of the total cost of antibiotics.
The study authors say antibiotic stewardship efforts should target certain conditions (i.e., upper respiratory tract infections, acute bronchitis, and non-infectious gastroenteritis) and on clinicians and children in cities of lower economic status.
"Real-world evidence is increasingly appreciated as fundamental to the development of antibiotic stewardship and interventions aiming at modifying antibiotic prescribing and improving patients' health," they wrote. "Tailored training and continuous education for primary clinicians that promote accurate diagnosis and evidence-based treatment based on clinical guidelines are urgently needed."
Study shows resistant UTIs rising in hospitals, communities in Australia
Originally published by CIDRAP News Nov 29
Rates of AMR in urinary Escherichia coli isolates are rising in both hospital and community settings in Australia, researchers reported last week in the Journal of Global Antimicrobial Resistance.
For the study, Australian researchers analyzed 108,262 urinary E coli isolates collected from a public hospital-based laboratory (34, 103 isolates) and a private community-based laboratory (74,159 isolates) in the Illawarra Shoelhaven region in New South Wales from 2007 to 2019. They tested the isolates for susceptibility to ampicillin, amoxicillin-clavulanate, cephalexin, norfloxacin, and trimethoprim, and used linear regression analysis to identify any significant changes in AMR rates over time. Up to 80% of all urinary tract infections (UTIs) are caused by E coli.
For all antibiotics other than ampicillin, the results of the linear regression analysis showed the AMR trends increased significantly over the 12-year period for both laboratory settings, with AMR rates consistently higher in the public hospital-based setting. But the study authors note that the volume of resistant isolates for commonly used antibiotics like trimethoprim and ampicillin were much higher in the community-based setting, where the vast majority of UTI treatments occur.
"There is a need for localised and regional surveillance of AMR," they wrote. Given that the largest volume is in the outpatient setting, and >90% of all antibiotic prescriptions are issued in primary care, interventions that incorporate the outpatient setting are critical to addressing AMR."
Countries agree to targets for human, animal antibiotic use
Originally published by CIDRAP News Nov 28
An international conference on AMR concluded last week with an agreement on global targets for antibiotic use in humans and animals.
In an official statement, participants in the Third Global High-Level Ministerial Conference on Antimicrobial Resistance committed to reducing the total amount of antibiotics used in the agri-food system by at least 30% to 50% by 2030, ending the use of medically important antibiotics for nonmedical veterinary purposes (ie, growth promotion) and ensuring that first-line, or Access antibiotics, represent 60% of overall human antibiotic consumption by 2030.
Participants also agreed to update and implement National Action Plans for AMR and strengthen national, regional, and global AMR and antibiotic-use surveillance.
The aim of the conference, which was attended by ministers of health, agriculture, animal health, and the environment, along with policy experts and representatives from the private sector and civil society, was to pave the way for "bold and specific" political commitments at the 2024 United Nations (UN) General Assembly High-Level Meeting on AMR.
The agreement was welcomed by members of the Quadripartite, which includes the WHO, the FAO, WOAH, and the UN Environment Programme. The Quadripartite is coordinating the global response to AMR.
"The use of antimicrobials in animals has shown an overall decrease over the last years. By strengthening biosecurity and husbandry practices, such as animal vaccination, we can further build on this great achievement and sustainably reach the agreed goals," WOAH Director-General Monique Eloit, DVM, said in a WHO press release. "Reducing the need for antimicrobials is the best way to prevent antimicrobial resistance."
"Antimicrobial resistance is one of the most urgent and complex challenges of our time, and yet perhaps because it is not as dramatic as a pandemic, a war or a humanitarian emergency, it doesn’t attract the same attention," said WHO Director-General Tedros Adhanom Ghebreyesus, PhD. "It is my firm hope that this meeting will pave the way towards bold—and concrete—political commitments at the 2024 UN General Assembly High Level Meeting on AMR."
