CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 661 enrolled
Drug / intervention
Cefepime/VNRX-5133 (taniborbactam) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03840148
NCT03840148Phase 3Completed
CompareCT.gov

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

Venatorx Pharmaceuticals, Inc.·interventional·Posted Feb 15, 2019·Updated Jun 6, 2025

In Brief

A Phase 3 clinical trial evaluating Cefepime/VNRX-5133 (taniborbactam) and Meropenem for Urinary Tract Infections and Acute Pyelonephritis. Completed, enrolled 661 participants across 78 sites in 15 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrinary Tract Infections, Acute Pyelonephritis
CountriesArgentina, Brazil, Bulgaria, China, Croatia, Hungary, Latvia, Mexico, Peru, Romania, Russia, Serbia, Turkey (Türkiye), Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedFeb 15, 2019
Enrollment StartAug 7, 2019
Primary CompletionDec 14, 2021
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 7.4 years ago

Interventions

Cefepime/VNRX-5133 (taniborbactam)drug

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.

Meropenemdrug

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.