Cefepime-taniborbactam statistically superior to meropenem for treatment of cUTI
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WASHINGTON — Cefepime-taniborbactam was statistically superior to meropenem for the treatment of complicated UTIs, including acute pyelonephritis, according to data presented at IDWeek.
“Carbapenem-resistant Enterobacterales and multidrug-resistant Pseudomonas aeruginosa are global antimicrobial resistant threats,” Paul C. McGovern, MD, senior vice president of medical sciences at Venatorx Pharmaceuticals, and colleagues wrote.
A possible treatment against these resistant pathogens seen with complicated UTIs (cUTIs), including acute pyelonephritis (AP), is cefepime-taniborbactam (FTB) — an investigational beta-lactam/beta-lactamase inhibitor combination.
Through Cefepime Rescue with Taniborbactam in cUTI (CERTAIN-1) — a randomized, double-blind, double-dummy, phase 3 study comparing FTB with meropenem (MEM) in adults hospitalized with cUTI or AP, McGovern and colleagues evaluated the safety and efficacy of FTB. According to the study, patients were randomly assigned 2:1 to receive either 2.5 g of FTB via IV or 1 g of MEM via IV for 7 days or up to 14 days in patients with bacteremia.
The primary endpoint was the composite response at the test of cure (TOC) visit in the micro-intent-to-treat (microITT) population, which McGovern described as a cohort of patients who have either one or two qualifying gram-negative pathogens present, greater than 105 colony-forming units/mL of urine, and the pathogen has to be sensitive to both treatments in the trial.
In total, 661 patients were randomly assigned, and 436 patients (66%) were included in the microITT population, including 42.2% with AP and 57.8% with cUTI.
Study data showed that composite success was achieved in 70% and 58% of FTB and MEM patients, respectively, although they found that FTB was “statistically superior” to MEM for the primary endpoint at the TOC (treatment difference FTB-MEM = 11.9%; 95% CI, 2.4-21.6).
Additionally, researchers observed treatment-emergent adverse events in 35.5% of FTB patients and 29% of MEM patients. The most common adverse events were headache (FTB 6.1%, MEM 3.7%) and diarrhea (FTB 4.1%, MEM 2.3%).
During a presentation at IDWeek, McGovern said that based on the success of CERTAIN-1, the data will be used as part of a new drug application package to the FDA in the first half of 2023.
“We hope that it will be approved and available for use by clinicians sometime early in 2024,” he said.
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McGovern PC, et al. Abstract 731. Presented at: IDWeek; Oct. 19- 23, 2022. Washington (hybrid meeting).
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