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Stewardship / Resistance Scan for Jul 27, 2021

Study: Use of restricted antibiotics rose after hospital ASP discontinued

The discontinuation of an antimicrobial stewardship program (ASP) at a South Korean hospital led to a rapid return of antibiotic use patterns observed before the ASP was implemented, researchers reported yesterday in Clinical Microbiology and Infection.

The interrupted time-series analysis looked at antibiotic use at the 859-bed hospital from September 2015 through August 2019. The hospital ASP, which focused on restricting the use of certain antibiotics, was implemented in September 2016 and discontinued in March 2018 after an infectious disease (ID) specialist resigned. Infection control measures at the hospital remained largely the same throughout the study period.

Immediately after discontinuation, the use of restrictive antibiotics increased by 41.06 days of therapy (DOT) per 1,000 patient-days in the hospital’s general ward and by 391.04 DOT/1,000 patient-days in the intensive care unit (ICU). Increases were driven by the use of carbapenems in the general ward and ICU and glycopeptides in the ICU. In addition, there were positive changes in the slope for the use of restrictive antibiotics in the general ward and the ICU.

While the use of broad-spectrum antibiotics declined after discontinuation of the ASP, the study authors suggest a large proportion of broad-spectrum antibiotic prescribing may have been shifted to restrictive antibiotics.

“Therefore, instead of a reduction in the use of broad-spectrum antibiotics, the use of restrictive antibiotics increased,” the authors wrote. “We suggest that the restrictive intervention for antibiotics is probably not educative and is not sustained.”

The study notes that the number of active ID specialists in South Korea is limited, and that despite an emphasis on the importance of antimicrobial stewardship, many ASPs have been discontinued because of a shortage of workers.
Jul 26 Clin Microbiol Infect study


FDA rejects new drug application for sulopenem

Pharmaceutical company Iterum Therapeutics said yesterday that the US Food and Drug Administration (FDA) has rejected the company’s new drug application (NDA) for approval of its oral antibiotic sulopenem etzadroxil/probenecid.

Iterum is seeking approval of the antibiotic for treatment of uncomplicated urinary tract infections (UTIs) in patients who do not do not respond to treatment with fluoroquinolones. But in a Jul 23 Complete Response Letter (CRL) to the company, the FDA said it could not approve the NDA in its current form.

While the FDA acknowledged the results of a phase 3 clinical trial indicated that patients with ciprofloxacin-resistant UTIs had a better response to oral sulopenem compared with ciprofloxacin, the agency said additional data from another clinical trial are needed to support approval for treatment of women with uncomplicated UTIs caused by fluoroquinolone-resistant pathogens.

The FDA also recommended that Iterum conduct further nonclinical research to determine the optimal dosing regimen.

“We are disappointed in this outcome and believe that the data package submitted was adequate for the approval of oral sulopenem,” Iterum Therapeutics Chief Executive Officer Corey Fishman said in a company press release.  “Regardless, we will evaluate the points raised in the CRL for discussion with the FDA to determine an expeditious path forward. We remain confident in the value of, and unmet medical need for, oral sulopenem to treat multi-drug resistant infections, including fast-growing quinolone non-susceptible pathogens.”

The company says sulopenem has received Qualified Infectious Disease Product and Fast-Track designations from the FDA for seven indications.
Jul 26 Iterum Therapeutics press release

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