drugset / Trial / NCT03687255
Safety and Efficacy Study of Cefepime-AAI101 in the Treatment of Complicated Urinary Tract Infections
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Multi-center, randomized, double-blind, non-inferiority study of cefepime 2 g/AAI101 500 mg combination compared to piperacillin 4 g/tazobactam 500 mg in a population of adult patients with cUTI or AP. The study will be conducted in approximately 115 sites located in the EU, the US, Central, South America and South Africa.
Timeline
- Start
- 2018-09-24
- Primary completion
- 2020-01-30
- Completion
- 2020-02-15
Publications
- Chandra P. Cefepime-enmetazobactam for complicated urinary tract infections: Redefining ESBL therapy. Indian J Med Res. 2026 Feb;163(2):183-193. doi: 10.25259/IJMR_2073_2025.
- Kaye KS, Belley A, Barth P, Lahlou O, Knechtle P, Motta P, Velicitat P. 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. JAMA. 2022 Oct 4;328(13):1304-1314. doi: 10.1001/jama.2022.17034.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cefepime | Small molecule | 2 g | Intravenous |
| Comparator | Piperacillin | Small molecule | 4 g | Intravenous |
| Comparator | Tazobactam | Small molecule | 500 mg | Intravenous |
| Subject | enmetazobactam | Small molecule | 500 mg | Intravenous |