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NCT03354598 · ClinicalTrials.gov registry record · Phase 3
Oral Sulopenem-etzadroxil/Probenecid Versus Ciprofloxacin for Uncomplicated Urinary Tract Infection in Adult Women
A Phase 3 study of Uncomplicated Urinary Tract Infections, sponsored by Iterum Therapeutics, International Limited.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,671
- Enrollment target
- 20
- Study locations
NCT03354598: Completed Phase 3 study of Uncomplicated Urinary Tract Infections, sponsored by Iterum Therapeutics, International Limited.
NCT03354598 is a Phase 3 study of Uncomplicated Urinary Tract Infections that has completed, run by Iterum Therapeutics, International Limited. The registered enrollment target is 1,671 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (116% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03354598, a Phase 3 study of Uncomplicated Urinary Tract Infections, has completed, sponsored by Iterum Therapeutics, International Limited.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,671 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a prospective, Phase 3, randomized, multi-center, double-blind study of the efficacy, tolerability, and safety of oral sulopenem-etzadroxil/probenecid versus oral ciprofloxacin for treatment of uncomplicated urinary tract infection (uUTI) in adult women
Primary Outcome
Overall Success: Clinical Success (resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms) AND Microbiologic success (eradication of the baseline pathogen)
Conditions Studied
Interventions
- DRUG Ciprofloxacin
- DRUG Sulopenem-Etzadroxil/Probenecid
Study Locations (20)
Florida
- Medical Facility - Bradenton
- Medical Facility - Clearwater
- Medical Facility - Doral
- Medical Facility - Edgewater
- Medical Facility - Hialeah
- Medical Facility - Lauderdale Lakes
- Medical Facility - Miami
- Medical Facility - Miami
- Medical Facility - Miami
California
- Medical Facility - Cerritos
- Medical Facility - Chula Vista
- Medical Facility - Fullerton
- Medical Facility - La Mesa
- Medical Facility - Los Angeles
- Medical Facility - San Diego
- Medical Facility - Sylmar
Arizona
- Medical Facility - Phoenix
- Medical Facility - Tolleson
Alabama
- Medical Facility - Birmingham
District of Columbia
- Medical Facility - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,671 participants |
| Start Date | 2018-08-01 |
| Est. Completion | 2020-01-20 |
| Phase | Phase 3 |
What the finished NCT03354598 record still lists
NCT03354598 is an interventional study that assigns participants to a tested intervention. Its 1,671 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (116% higher).
The record links to 1 condition, with Uncomplicated Urinary Tract Infections appearing as the primary indexed condition, and to 2 interventions - of which Ciprofloxacin is the first listed.
NCT03354598 names 20 study sites across 5 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT03354598 about?
NCT03354598 is a clinical study titled "Oral Sulopenem-etzadroxil/Probenecid Versus Ciprofloxacin for Uncomplicated Urinary Tract Infection in Adult Women". This is a prospective, Phase 3, randomized, multi-center, double-blind study of the efficacy, tolerability, and safety of oral sulopenem-etzadroxil/probenecid versus oral ciprofloxacin for treatment of uncomplicated urinary tract infection (uUTI) in adult women
What is the current status of trial NCT03354598?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,671 participants. The study started on 2018-08-01. Estimated completion is 2020-01-20.
What conditions does trial NCT03354598 study?
This clinical trial studies the following conditions: Uncomplicated Urinary Tract Infections.
What interventions are being tested in trial NCT03354598?
The interventions under investigation include: Ciprofloxacin (DRUG), Sulopenem-Etzadroxil/Probenecid (DRUG).
Who is sponsoring clinical trial NCT03354598?
This trial is sponsored by Iterum Therapeutics, International Limited, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03354598 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03354598's enrollment target sits among peer trials
1,671 136th of 2000 higher than 1,865 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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