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Cefepime and enmetazobactam

(Exblifep®)

Exblifep®

Drug updated on 10/18/2024

Dosage FormInjection (intravenous; 2.5 grams [2 grams cefepime; 0.5 grams enmetazobactam])
Drug ClassCephalosporin antibacterials and beta-lactamase inhibitors
Ongoing and
Completed Studies		ClinicalTrials.gov

Indication

  • Indicated for the treatment of patients 18 years and older with complicated urinary tract infections (cUTI) including pyelonephritis caused by designated susceptible microorganisms.

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Summary
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  • This summary is based on the review of one randomized controlled trial(s). [1]
  • Cefepime/enmetazobactam achieved an overall treatment success rate of 79.1% (273/345) compared to 58.9% (196/333) for piperacillin/tazobactam, with a between-group difference of 21.2% (95% CI (Confidence Interval), 14.3% to 27.9%).
  • Cefepime/enmetazobactam met the criteria for noninferiority and demonstrated superiority over piperacillin/tazobactam in the primary outcome, defined as clinical cure combined with microbiological eradication in patients with complicated urinary tract infections or acute pyelonephritis.
  • Treatment-emergent adverse events occurred in 50.0% of patients receiving cefepime/enmetazobactam (258/516) and 44.0% of those receiving piperacillin/tazobactam (228/518). Most adverse events were mild to moderate in severity (89.9% for cefepime/enmetazobactam vs. 88.6% for piperacillin/tazobactam).
  • A higher percentage of patients discontinued cefepime/enmetazobactam due to adverse events compared to piperacillin/tazobactam (1.7% vs. 0.8%).
  • There is no population types or subgroups information available in the reviewed studies.