NCT03840148

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

A Phase 3, Randomized, Double-blind, Active Controlled Noninferiority Study Evaluating the Efficacy, Safety, and Tolerability of Cefepime/VNRX-5133 in Adults With Complicated Urinary Tract Infections (cUTI), Including Acute Pyelonephritis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 661 (actual)
• Sponsor: Venatorx Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urinary Tract Infections
• Acute Pyelonephritis

Interventions

Type	Name	Description
DRUG	Cefepime/VNRX-5133 (taniborbactam)	Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.
DRUG	Meropenem	Meropenem will be administered q8h IV over 30 minutes for 7 days (up to 14 days for patients with bacteremia). Patients will also receive cefepime/VNRX-5133 placebo administered via IV over a 2-hour period.

Timeline

• Start date: 2019-08-07
• Primary completion: 2021-12-14
• Completion: 2021-12-14
• First posted: 2019-02-15
• Last updated: 2025-06-06
• Results posted: 2024-05-29

Locations

78 sites across 15 countries: United States, Argentina, Brazil, Bulgaria, China, Croatia, Hungary, Latvia, Mexico, Peru, Romania, Russia, Serbia, Turkey (Türkiye), Ukraine

Regulatory

• FDA-regulated drug study