Cefepime/enmetazabactam is not inferior in complicated UTI

For patients with complicated urinary tract infection (UTI) or acute pyelonephritis caused by gram-negative organisms, cefepime/enmetazabactam is non-inferior and superior to piperacillin/tazabactam in clinical management and microbiological eradication, according to a study published in the October 4 issue of the journal. in Journal of the American Medical Association.

Kate C. Kaye, MD, PhD, of the Robert Wood Johnson Medical School in New Brunswick, New Jersey, and colleagues conducted a randomized trial at 90 sites in Europe, North and Central America, South America, and South Africa. to examine whether cefepime/enmetazabactam is non-inferior to piperacillin/tazabactam for the primary efficacy outcome in patients with complicated UTI or acute pyelonephritis. The pre-specified non-inferiority margin was -10 percent; the comparison of superiority was also predetermined when inferiority was established. A total of 1041 patients were randomized and 995 completed the trial.

The researchers found that the primary outcome (proportion of patients who achieved total treatment success, defined as clinical cure combined with microbiological eradication) occurred in 79.1 and 58.9 percent of patients treated with cefepime/enmetazabactam and piperacillin/tazabactam, respectively. Treatment-emergent adverse events occurred in 50.0 and 44.0 percent of patients treated with cefepime/enmetazabactam and piperacillin/tazabactam, respectively; most of them were mild to moderate in severity.

“Further studies are needed to determine the potential role of cefepime/enmetazobactam in the treatment of complicated UTIs and pyelonephritis,” the authors write.

Several authors have disclosed financial ties to pharmaceutical companiesincluding Allecra Therapeutics, which is developing cefepime/enmetazabactam and funded the study.

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