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Safety and Efficacy Study of Cefepime/VNRX-5133 in Patients With Complicated Urinary Tract Infections | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

NCT03840148•Venatorx Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Adult male and female
•Documented diagnosis of pyuria
•Documented diagnosis of cUTI or Acute Pyelonephritis (AP)

Exclusion Criteria

•Receipt of effective antibacterial drug therapy for cUTI for more than 24 hours during the previous 72 hours prior to randomization
•A urine culture result is resistant to meropenem or a gram negative pathogen is not identified or more than 2 microorganisms are isolated or a confirmed fungal UTI is identified
•Required use of nonstudy systemic bacterial therapy
•Suspected or confirmed prostatitis or urinary tract symptoms attributable to sexually transmitted disease
•Patients with perinephric or renal abscess
•Patients with renal transplantation or receiving hemodialysis or peritoneal dialysis
•Abnormal labs

Locations (78)

Site 184003

Buena Park, California, United States

Site 184002

Chula Vista, California, United States

Site 184001

La Mesa, California, United States

184012

Northridge, California, United States

Site 103203

Córdoba, Argentina

Site 107601

Belo Horizonte, Brazil

Site 107608

São Paulo, Brazil

Site 110009

Gabrovo, Bulgaria

Site 110002

Pleven, Bulgaria

Site 110007

Plovdiv, Bulgaria

Key Dates

Start Date

August 7, 2019

Primary Completion Date

December 14, 2021

Completion Date

December 14, 2021

Last Updated

June 6, 2025

Enrollment

661

ACTUAL participants

Conditions

Urinary Tract InfectionsAcute Pyelonephritis

Interventions

Cefepime/VNRX-5133 (taniborbactam)

DRUG

Meropenem

DRUG

A Study of LBP-EC01 in the Treatment of Acute Uncomplicated UTI Caused by Drug Resistant E. Coli (ELIMINATE Trial)

NCT05488340

Urinary Tract Infections

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RECRUITINGNA

Evaluation of the Effectiveness and Safety of a Vaginal Gel for Prevention of Recurrent Urinary Tract Infections

NCT07233473

Urinary Tract Infections (UTIs)

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RECRUITING

Research of the Consequences on the Digestive Tract Following the Proposed Treatments for a Urinary Infection in Children

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 6, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study of LBP-EC01 in the Treatment of Acute Uncomplicated UTI Caused by Drug Resistant E. Coli (ELIMINATE Trial)

Evaluation of the Effectiveness and Safety of a Vaginal Gel for Prevention of Recurrent Urinary Tract Infections

Research of the Consequences on the Digestive Tract Following the Proposed Treatments for a Urinary Infection in Children

Ureteral Stent Exchange Abstention in Urinary Tract Infections

Vaginal Ecosystem and Network in the United States Study

PRObiotics for KIdney Transplantation