drugset / Trial / NCT03840148
Safety and Efficacy Study of Cefepime/VNRX-5133 in Patients With Complicated Urinary Tract Infections
RandomizedParallel-groupDouble-blindTreatment
Summary
This study will assess the safety and efficacy of cefepime/VNRX-5133 compared with meropenem in both eradication of bacteria and in symptomatic response in patients with cUTIs.
Timeline
- Start
- 2019-08-07
- Primary completion
- 2021-12-14
- Completion
- 2021-12-14
Publications
- Belley A, Cusick SM, Pevear DC, Koeth L, DiFranco-Fisher J, Kothari N, Hawser S, Moeck G. Establishing the reference broth microdilution MIC method for cefepime-taniborbactam. J Clin Microbiol. 2025 Sep 10;63(9):e0066125. doi: 10.1128/jcm.00661-25. Epub 2025 Aug 19.
- Moeck G, Gasink LB, Mendes RE, Woosley LN, Dorr M, Chen H, Wagenlehner FM, Henkel T, McGovern PC. Patient outcomes by baseline pathogen resistance phenotype and genotype in CERTAIN-1, a Phase 3 study of cefepime-taniborbactam versus meropenem in adults with complicated urinary tract infection. Antimicrob Agents Chemother. 2024 Jul 9;68(7):e0023624. doi: 10.1128/aac.00236-24. Epub 2024 May 23.
- Wagenlehner FM, Gasink LB, McGovern PC, Moeck G, McLeroth P, Dorr M, Dane A, Henkel T; CERTAIN-1 Study Team. Cefepime-Taniborbactam in Complicated Urinary Tract Infection. N Engl J Med. 2024 Feb 15;390(7):611-622. doi: 10.1056/NEJMoa2304748.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cefepime | Small molecule | — | Intravenous |
| Comparator | Meropenem | Small molecule | 1 g | Intravenous |
| Subject | taniborbactam | Other / unclassified | — | Intravenous |