The results of a phase 3 clinical trial indicate that a novel combination antibiotic may soon be available for treatment of complicated urinary tract infections (cUTIs) caused by multidrug-resistant gram-negative bacteria.

The trial results, published this week in JAMA, show that cefepime/enmetazobactam, which combines a fourth-generation cephalosporin with a novel beta-lactamase inhibitor, was noninferior to piperacillin/tazobactam in patients with cUTIs or acute pyelonephritis, and met superiority criteria with respect to clinical cure and microbiologic eradication.

The trial investigators say that with the increasing prevalence of bacteria carrying extended-spectrum beta-lactamases (ESBLs), which are enzymes that cause resistance to most beta-lactam antibiotics, more therapeutic options are needed for difficult-to-treat infections. Piperacillin/tazobactam has been a widely used therapy for cUTIs and other infections caused by ESBL-producing bacteria because it's an effective an alternative to carbapenems. But resistance to the treatment has been rising, and the authors say it may no longer be appropriate.

"These findings suggest that cefepime/enmetazobactam may be an appropriate empirical therapy for suspected gram-negative complicated UTI," they wrote.

Based on these results, French biopharmaceutical company Allecra Therapeutics said in a press release that it is planning to complete a submission for marketing authorization for cefepime/enmetazobactam to the European Medicines Agency by the end of the year. The company is also preparing to submit a New Drug Application to the US Food and Drug Administration.

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