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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 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. The trial reports 20 study locations across 5 states.
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
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03354598
The ClinicalTrials.gov registry entry for NCT03354598 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,671 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Iterum Therapeutics, International Limited, which has 6 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 5 distinct geographic areas - top geographies include 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.
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