Compared with piperacillin/tazobactam in the phase 3 ALLIUM trial, cefepime/enmetazobactam met the criteria for noninferiority as well as superiority for clinical cure and microbiological eradication in patients with complicated urinary tract infection (UTI) or acute pyelonephritis caused by gram-negative pathogens, researchers report. “These findings suggest that cefepime/enmetazobactam may be an appropriate empirical therapy for suspected gram-negative complicated UTI,” the investigators conclude. “Further research is needed to determine the potential role for cefepime/enmetazobactam in the treatment of complicated UTI and pyelonephritis.”
At 90 international sites, a primary outcome of the proportion of patients who achieved overall treatment success and a noninferiority margin of 10% produced these results: “Among 1041 patients randomized (mean age, 54.7 years; 573 women [55.0%]), 1034 (99.3%) received study drug and 995 (95.6%) completed the trial. Among the primary analysis set, the primary outcome occurred in 79.1% (273/345) of patients receiving cefepime/enmetazobactam compared with 58.9% (196/333) receiving piperacillin/tazobactam (between-group difference, 21.2% [95% CI, 14.3% to 27.9%]). Treatment-emergent adverse events occurred in 50.0% (258/516) of patients treated with cefepime/enmetazobactam and 44.0% (228/518) with piperacillin/tazobactam; most were mild to moderate in severity (89.9% vs 88.6%, respectively). A total of 1.7% (9/516) of participants who received cefepime/enmetazobactam and 0.8% (4/518) of those who received piperacillin/tazobactam did not complete the assigned therapy due to adverse events.”