Our weekly wrap-up of antimicrobial stewardship & antimicrobial resistance scans
FDA advisers approve fecal transplant treatment for recurrent C difficile
Swiss biopharmaceutical company Ferring Pharmaceuticals announced yesterday that the Food and Drug Administration's (FDA's) Vaccine and Related Biologic Products Advisory Committee (VRBPAC) voted in favor of the company's investigational fecal microbiota transplant (FMT)-based therapy.
According to a company press release, VRBPAC voted 13 to 4 that the data from the biologics license application were adequate to support the effectiveness of RBX2660 (Rebyota) to reduce the recurrence of Clostridioides difficile infection (CDI) in adults following antibiotic treatment, and 12 to 1 that the data were adequate to support safety of the microbiota-based live therapeutic treatment, which is delivered via an enema.
FMT therapy involves transplanting beneficial bacteria into the gut of a patient with recurrent CDI, which is traditionally treated with antibiotics. FMT has been found in several studies to be an effective treatment for recurrent CDI, and the most recent treatment guidelines from the Infectious Diseases Society of America recommend it for patients who've had several bouts of recurrent CDI and have not been cured by antibiotics.
Up to 35% of CDI cases recur after initial diagnosis, and patients who have recurrent CDI have a significantly higher risk of further infection.
"Today's advisory committee vote represents an important milestone in Ferring's ongoing efforts to address the unmet need for interventions that can reduce the incidence of recurrent C. difficile infection, which represents a significant health burden for patients," Mirjam Mol-Arts, MD, executive vice president and chief medical officer of Ferring Pharmaceuticals, said in the release.
RBX2660 would be the first FMT therapy approved by the FDA.
Sep 22 Ferring Pharmaceuticals press release
Hemodialysis patients have fourfold higher C diff risk, study finds
A systematic review and meta-analysis found that chronic kidney disease patients who require maintenance hemodialysis (MHD) have a significantly increased risk of CDI compared to those who don't require MHD, researchers reported today in Infection Control & Hospital Epidemiology.
To evaluate the burden of and potential risk factors for CDI in MHD patients, who are known to be at increased risk for CDI because of substantial antibiotic exposure and frequent hospitalizations, Brown University researchers reviewed 240 studies published prior to March 2022; 15 of these studies provided data on CDI rates among people requiring MHD, and 8 of them also provided CDI rates among people not requiring MHD.
The pooled prevalence of CDI among persons requiring MHD was 19.14%, compared with 5.16% among persons not requiring MHD (odds ratio [OR], 4.35; 95% confidence interval [CI], 2.07 to 9.16). The linear increase in CDI over time for both groups was significant, increasing an average of 31.97% annually from 1993 to 2017 (OR, 1.32; 95% CI, 1.1 to 1.58). The linear annual increase was similar among persons requiring and not requiring MHD (OR, 1.28; 95% CI, 1.13 to 1.45).
Risk factors specific to the MHD population included being 65 years of age or older, serum albumin levels of 3 grams per deciliter or lower, higher Charlson comorbidity index scores, HIV, and bloodstream infections. Mortality associated with CDI was double among people requiring MHD, and the case-fatality rate ranged from 13.2% to 68.8%.
"The substantially higher and rising rates of CDI among persons requiring MHD and associated higher morbidity and mortality compared to persons not requiring MHD both emphasize the importance of preventing C. difficile spread and CDI in this patient population," the authors wrote.
Sep 23 Infect Control Hosp Epidemiol study
Spero, GSK to partner on oral carbapenem for complicated UTIs
Originally published by CIDRAP News Sep 22
Biopharmaceutical company Spero Therapeutics announced today that it has entered into a licensing agreement with GSK for the antibiotic tebipenem pivoxil hydrobromide (HBr).
Under the agreement, GSK will receive an exclusive license to develop and commercialize the novel oral carbapenem, which is being developed for treatment of complicated urinary tract infections, in all territories except Japan and certain other Asian countries.
"There is a high unmet medical need for a novel oral antibiotic as an alternative to intravenous hospital therapy for drug-resistant complicated urinary tract infections," Luke Miels, MBA, Chief Commercial Officer for GSK, said in a press release.
In April, the FDA told Spero that its review of the New Drug Application for tebipenem HBr had identified issues in the phase 3 trial results for the drug and that the data may not support approval. Following that meeting, the company announced that it was stopping all commercialization activities for tebipenem HBr and would reduce its workforce.
The FDA recently told Spero, however, that positive results from an additional phase 3 trial supported by confirmatory nonclinical evidence of efficacy could be sufficient to support approval. The company says it expects to start the trial in 2023.
"Spero's agreement with GSK provides a critical step towards fully realizing the value tebipenem HBr can potentially provide to physicians, payors, and patients," said Spero Chief Executive Officer Ankit Mahadevia, MD.
Sep 22 Spero Therapeutics press release
May 4 CIDRAP News scan
Scottish report shows no increase in healthcare-associated infections
Originally published by CIDRAP News Sep 21
A new report from Scotland's national health service shows that three key healthcare-associated infections remained stable or declined from 2020 to 2021.
Surveillance data compiled by Antimicrobial Resistance and Healthcare Associated Infection Scotland (ARHAIS) showed that despite an increase in the number of patients admitted to Scottish acute care hospitals in 2021 compared with 2020 and an increase in total occupied bed days, incidence of CDI and Staphylococcus aureus bacteremia (SAB) remained stable, at 20.8 and 29.1 per 100,000 population, respectively.
Incidence of healthcare-associated Escherichia coli bacteremia (ECB)—the most common cause of gram-negative bacteremia—fell by 6.4% from 2020 to 2021, to 37.1 per 100,000 bed-days.
Overall, non–COVID-19 healthcare outbreaks and incidents declined, from 136 in 2020 to 118 in 2021. The annual incidence of community-associated CDI, SAB, and ECB remained stable from 2020 to 2021.
ARHAIS also reports that it continues to review and develop guidance documents for the prevention and control of infections across all care settings. Surveillance priorities for 2022 include further investigation into the impact of the COVID-19 pandemic on healthcare-associated infections and the development of wider gram-negative bacteremia surveillance.
Sep 20 ARHAIS 2021 annual report
Survey finds physician empathy linked to lower antibiotic prescribing
Originally published by CIDRAP News Sep 21
A survey of general practitioners (GPs) in Denmark found that those who exhibited high levels of empathy had different antibiotic prescribing habits than low-empathy GPs, particularly when it comes to prescribing penicillins, researchers reported yesterday in BMC Primary Care.
The survey, sent to a stratified sample of 1,196 Danish GPs in 2016, included questions about demographic, professional, and antibiotic prescribing characteristics and used the Jefferson Scale of Empathy for Health Professionals to assess self-reported physician empathy. The high-empathy group was defined as GPs who had empathy scores above the 90th percentile, and the low-empathy group were those with scores below the 90th percentile. The response rate was 39%.
The results showed that 61% of GPs in the top decile of the empathy score were women. GPs in this decile reported the following person-centered factors as more important for their job satisfaction than the bottom decile: the patient-physician relationship, interaction with colleagues, and intellectual stimulation.
Overall, high-empathy scoring GPs had 19% fewer antibiotic prescriptions per year than the low-empathy group and prescribed significantly less penicillin (34% less) than the low-empathy GPs. This was true for most penicillin subcategories. The intra-profile variation index and confidence intervals showed less prescribing uncertainty among GPs with high empathy.
There were no significant differences in age, practice setting (urban vs rural), practice type (partnership vs solo), overall job satisfaction, or GP’s value of prestige and economic profit for their job satisfaction.
The authors say the findings suggest that high-empathy GPs may be more likely to spend time explaining to patients why they don't need an antibiotic rather than simply comply with the patient's request.
"Practitioners with a degree of empathy may prescribe less penicillin as they take better time to explain, meet the patient's fears and expectations, and evaluate antibiotic choice in their community with reference to local resistance patterns," the authors wrote. "A likely explanation may be that high empathy GPs better identify patient’s concerns and expectations and are able to contextualize the patient’s infection in the community."
Sep 20 BMC Prim Care study