For patients with complicated urinary tract infection (UTI) or acute pyelonephritis caused by gram-negative pathogens, cefepime/enmetazobactam is noninferior and superior to piperacillin/tazobactam for clinical cure and microbiological eradication, according to a study published in the Oct. 4 issue of the Journal of the American Medical Association.
Keith S. Kaye, M.D., Ph.D., from 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/enmetazobactam was noninferior to piperacillin/tazobactam for the primary outcome of treatment efficacy in patients with complicated UTIs or acute pyelonephritis. The prespecified noninferiority margin was −10 percent; a superiority comparison was also prespecified if noninferiority was established. A total of 1,041 patients were randomly assigned, and 995 completed the trial.
The researchers found that the primary outcome (proportion of patients who achieved overall treatment success, defined as clinical cure combined with microbiological eradication) occurred in 79.1 and 58.9 percent of patients receiving cefepime/enmetazobactam and piperacillin/tazobactam, respectively. Treatment-emergent adverse events occurred in 50.0 and 44.0 percent of patients receiving cefepime/enmetazobactam and piperacillin/tazobactam, respectively; most were mild to moderate in severity.
“Further research is needed to determine the potential role for cefepime/enmetazobactam in the treatment of complicated UTI and pyelonephritis,” the authors write.
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