Cefepime-Taniborbactam Superior to Meropenem for Complicated UTI

Treatment with cefepime-taniborbactam was superior to meropenem in adults with complicated urinary tract infection or acute pyelonephritis.

Cefepime-taniborbactam therapy is superior to meropenem for the treatment of complicated urinary tract infection (cUTI), including acute pyelonephritis (AP), according to study results presented at IDWeek 2022, held from October 19 to 23, in Washington, DC.

Carbapenem-resistant Enterobacterales and multidrug-resistant Pseudomonas aeruginosa are a global threat to antimicrobial resistance and may be causative pathogens in cUTI.

Researchers conducted a randomized, double-blind, double-dummy, phase 3 trial to compare the effects of cefepime-taniborbactam with meropenem among adults hospitalized with cUTI, including acute pyelonephritis. Cefepime-taniborbactam, an investigational b-lactam/b-lactamase inhibitor combination, has shown activity against Enterobacterales and P aeruginosa organisms that express serine and metallo-b-lactamases. Patients were randomly assigned in a 2:1 fashion to receive either cefepime-taniborbactam or meropenem for 7 days. Patients with bacteremia received treatment for up to 14 days.

The primary composite endpoint was microbiologic and clinical response rates at the test of cure visit among the micro intention-to-treat (ITT) population. The noninferiority margin (-15%) and a prespecified test for superiority for the primary endpoint was determined after noninferiority was confirmed.

Among 661 patients included in the intitial analysis, 436 (66.0%) comprised the micro ITT population. Of these patients, 42.2% had acute pyelonephritis, 57.8% had cUTI, 38.0% were aged 65 years and older, and 13.1% had bacteremia.

FTB was safe and well-tolerated with a safety profile similar to MEM.

Among patients included in the micro ITT analysis who received cefepime-taniborbactam or meropenem, the rate of clinical and microbiologic response was 88.7% and 86.0% at treatment completion, 70.0% and 58.0% at the test of cure visit, and 63.5% and 51.7% at the late follow-up visit, respectively. Overall, the response rate difference was 11.9% (95% CI, 2.4%-21.6%; P =.0136) at the test of cure visit among patients in the cefepime-taniborbactam vs meropenem groups, indicating the statistical superiority of cefepime-taniborbactam.

Secondary endpoints and subgroup analyses results were consistent with the primary analysis.

Treatment-emergent adverse events occurred among 35.5% of patients who received cefepime-taniborbactam and 29.0% of those who received meropenem, of whom 2.0% and 1.8% experienced severe events, respectively. The most common treatment-emergent adverse events were headache and diarrhea.

According to the researchers, “FTB [cefepime-taniborbactam] was safe and well-tolerated with a safety profile similar to MEM [meropenem].”

Disclosure: Multiple authors declared affiliations with industry. Please see the original article for a full list of disclosures.


McGovern PC, Wagenlehner F, Gasink L, et al. Certain-1: a phase 3 study of cefepime-taniborbactam efficacy and safety in the treatment of complicated urinary tract infections (cUTI), including acute pyelonephritis (AP). Presented at: IDWeek 2022; October 19-23; Washington, DC. Abstract 731.