The combination of cefepime, a cephalosporin antibiotic, and enmetazobactam, a novel extended-spectrum β-lactamase inhibitor (Exblifep; Allecra Therapeutics) was found to be superior to piperacillin-tazobactam in the treatment of complicated urinary tract infections (cUTI), including acute pyelonephritis, according to top-line results from the phase 3 ALLIUM trial.

The double-blind, non-inferiority study included 1034 patients randomized to receive cefepime 2g-enmetazobactam 0.5g or piperacillin 4g-tazobactam 0.5g every 8 hours as a 2 hour continuous intravenous infusion. The primary efficacy end point was defined as the composite success outcome of clinical cure (symptoms resolution) and microbiological eradication (<103 CFU/mL in urine culture) at the test-of-cure visit.

Results showed that 79.1% of patients treated with cefepime-enmetazobactam achieved overall success compared with 58.9% of the piperacillin-tazobactam group (adjusted stratified difference, 21.2% [95% stratified Newcombe CI, 14.3-27.9]). Additionally, the safety profile of cefepime-enmetazobactam was found to be comparable to piperacillin-tazobactam regarding treatment discontinuations (5.2% vs 4.0%) and serious adverse events (4.3% vs 3.7% [0.2% vs 0.6% assessed as drug related]), respectively.

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“The superiority demonstrated in the primary end point, at test of cure, combined with a comparable safety profile to that of well tolerated and widely used piperacillin-tazobactam support the potential use of cefepime-enmetazobactam as a new empiric and carbapenem-sparing treatment for multi-drug resistant Gram-negative infections,” said Patrick Velicitat MD, Chief Medical Officer of Allecra Therapeutics.

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This article originally appeared on MPR