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NCT03840148 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy Study of Cefepime/VNRX-5133 in Patients With Complicated Urinary Tract Infections
A Phase 3 study of Urinary Tract Infections and Acute Pyelonephritis, sponsored by Venatorx Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 661
- Enrollment target
- 20
- Study locations
NCT03840148: Completed Phase 3 study of Urinary Tract Infections and Acute Pyelonephritis, sponsored by Venatorx Pharmaceuticals.
NCT03840148 is a Phase 3 study of Urinary Tract Infections and Acute Pyelonephritis that has completed, run by Venatorx Pharmaceuticals. The registered enrollment target is 661 participants, above the 439-participant average among 34 other Urinary Tract Infections trials with a reported enrollment target (51% higher). The trial reports 20 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03840148, a Phase 3 study of Urinary Tract Infections and Acute Pyelonephritis, has completed, sponsored by Venatorx Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 661 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10\^5 CFU/mL) is eradicated to \<10\^3 CFU/mL. Clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI.
Conditions Studied
Interventions
- DRUG Meropenem
- DRUG Cefepime/VNRX-5133 (taniborbactam)
Study Locations (20)
Other
- Site 103203 - Córdoba
- Site 107601 - Belo Horizonte
- Site 107608 - São Paulo
- Site 110009 - Gabrovo
- Site 110002 - Pleven
- Site 110007 - Plovdiv
- Site 110003 - Rousse
- Site 110010 - Sofia
- Site 110004 - Sofia
- Site 110005 - Sofia
- Site 110008 - Sofia
- Site 110001 - Veliko Tarnovo
- Site 156022 - Baotou
- Site 156002 - Beijing
- Site 156006 - Beijing
- Site 156015 - Chendu
California
- Site 184003 - Buena Park
- Site 184002 - Chula Vista
- Site 184001 - La Mesa
- 184012 - Northridge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 661 participants |
| Start Date | 2019-08-07 |
| Est. Completion | 2021-12-14 |
| Phase | Phase 3 |
What the finished NCT03840148 record still lists
NCT03840148 is an interventional study that assigns participants to a tested intervention. The registered 661 participants enrollment target is mid-sized for trials with a published cap, above the 439-participant average among 34 other Urinary Tract Infections trials with a reported enrollment target (51% higher).
The record links to 2 conditions, with Urinary Tract Infections appearing as the primary indexed condition, and to 2 interventions - of which Meropenem is the first listed.
NCT03840148 names 20 study sites across 2 states, led by Other, California.
Frequently Asked Questions
What is clinical trial NCT03840148 about?
NCT03840148 is a clinical study titled "Safety and Efficacy Study of Cefepime/VNRX-5133 in Patients With Complicated Urinary Tract Infections". 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.
What is the current status of trial NCT03840148?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 661 participants. The study started on 2019-08-07. Estimated completion is 2021-12-14.
What conditions does trial NCT03840148 study?
This clinical trial studies the following conditions: Urinary Tract Infections, Acute Pyelonephritis.
What interventions are being tested in trial NCT03840148?
The interventions under investigation include: Meropenem (DRUG), Cefepime/VNRX-5133 (taniborbactam) (DRUG).
Who is sponsoring clinical trial NCT03840148?
This trial is sponsored by Venatorx Pharmaceuticals, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03840148 being conducted?
This trial has 20 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT03840148's enrollment target sits among peer trials
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