Safety and Efficacy Study of Cefepime/VNRX-5133 in Patients With Complicated Urinary Tract Infections

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

Outcome

Met primary endpoint

paper Cefepime-taniborbactam was superior to meropenem regarding the primary outcome (treatment difference, 12.6 percentage points; 95% confidence interval, 3.1 to 22.2; P = 0.009). PMID 38354140 ↗

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

Indications