Drug updated on 12/11/2024
Dosage Form | Injection (intravenous; 2.5 grams [2 grams cefepime; 0.5 grams enmetazobactam]) |
Drug Class | Cephalosporin 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.
Latest News
Summary
- This summary is based on the review of one randomized controlled trial. [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% confidence interval (CI), 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.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Exblifep (cefepime and enmetazobactam) Prescribing Information. | 2024 | Allecra Therapeutics SAS., 68300 Saint Louis, France |
Randomized Controlled Trials
Document Title | Sex Distribution | Year | Source |
---|---|---|---|
Effect of Cefepime/Enmetazobactam vs Piperacillin/Tazobactam on Clinical Cure and Microbiological Eradication in Patients With Complicated Urinary Tract Infection or Acute Pyelonephritis: A Randomized Clinical Trial | 1,034Subjects F: 55% M: 45% | 2022 | JAMA |
Sex Distribution:
F:55%
M:45%
1034Subjects
Year:
2022
Source:JAMA