Photo Credit: Tharakorn
The following is a summary of “Cefepime–Taniborbactam in Complicated Urinary Tract Infection,” published in the February 2024 issue of Infectious Disease by Wagenlehner et al.
Researchers conducted a retrospective analysis to assess the effectiveness of cefepime–taniborbactam against problematic, antibiotic-resistant bacteria like Enterobacterales and Pseudomonas aeruginosa.
They conducted a phase 3, double-blind, randomized trial, assigning hospitalized adults with complicated urinary tract infection (UTI), including acute pyelonephritis, in a 2:1 ratio to receive intravenous cefepime–taniborbactam (2.5 g) or meropenem (1 g) every 8 hours for 7 days, extendable to 14 days for bacteremia. The primary outcome was both microbiologic and clinical success (composite success) on trial days 19 to 23 in the microbiologic intention-to-treat (microITT) population (patients who had a qualifying gram-negative pathogen against which both study drugs were active). After confirming noninferiority, a prespecified superiority analysis of the primary outcome was conducted.
The results showed 661 patients were randomized, and 436 (66.0%) were in the microITT population, mean age was 56.2 years, with 38.1% aged 65 or older. Within the microITT group, 57.8% had complicated UTIs, 42.2% had acute pyelonephritis, and 13.1% had bacteremia. Composite success was achieved in 207 of 293 patients (70.6%) in the cefepime–taniborbactam group and 83 of 143 patients (58.0%) in the meropenem group. Cefepime–taniborbactam outperformed meropenem for the primary outcome (treatment difference: 12.6 percentage points; 95% CI: 3.1 to 22.2; P=0.009). Superiority persisted at late follow-up (trial days 28 to 35), with cefepime–taniborbactam showing higher composite and clinical success rates. Adverse events occurred in 35.5% of cefepime–taniborbactam patients and 29.0% of meropenem patients, with headache, diarrhea, constipation, hypertension, and nausea being common. The frequency of serious adverse events was comparable between the two groups.
Investigator concluded that cefepime-taniborbactam surpassed meropenem in treating complex UTIs and acute pyelonephritis, exhibiting comparable safety to meropenem.