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NCT05584657 · ClinicalTrials.gov registry record · Phase 3
Oral Sulopenem Versus Amoxicillin/Clavulanate for Uncomplicated Urinary Tract Infection in Adult Women
A Phase 3 study of Urinary Tract Infections and Cystitis, sponsored by Iterum Therapeutics, International Limited.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,229
- Enrollment target
- 20
- Study locations
NCT05584657 is a Phase 3 study of Urinary Tract Infections and Cystitis that has completed, run by Iterum Therapeutics, International Limited. The registered enrollment target is 2,229 participants, above the 393-participant average among 34 other Urinary Tract Infections trials with a reported enrollment target (467% higher). The trial reports 20 study locations across 4 states.
The verdict
NCT05584657, a Phase 3 study of Urinary Tract Infections and Cystitis, has completed, sponsored by Iterum Therapeutics, International Limited.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,229 participants
- Enrollment target
- 20
- Study locations
Study Summary
Study 310 is a clinical study which compares the effectiveness of oral sulopenem versus oral amoxicillin/clavulanate for the treatment of adult women with uncomplicated urinary tract infection.
Conditions Studied
Interventions
- DRUG Amoxicillin/clavulanate
- DRUG Sulopenem etzadroxil/probenecid
Study Locations (20)
California
- Medical Facility - Bakersfield
- Medical Facility - Chula Vista
- Medical Facility - Fullerton
- Medical Facility - Garden Grove
- Medical Facility - Huntington Beach
- Medical Facility 2 - Huntington Park
- Medical Facility - Huntington Park
- Medical Facility - Irvine
- Medical Facility - La Mesa
- Medical Facility - Lancaster
Arizona
- Medical Facility - Peoria
- Medical Facility3 - Phoenix
- Medical Facility - Phoenix
- Medical Facility2 - Phoenix
- Medical Facility - Tucson
Alabama
- Medical Facility - Cullman
- Medical Facility - Saraland
- Medical Facility - Sheffield
Arkansas
- Medical Facility2 - Hot Springs
- Medical Facility - Hot Springs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,229 participants |
| Start Date | 2022-10-18 |
| Est. Completion | 2023-11-21 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05584657
The ClinicalTrials.gov registry entry for NCT05584657 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 2,229 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 393-participant average among 34 other Urinary Tract Infections trials with a reported enrollment target (467% higher). The listed sponsor is Iterum Therapeutics, International Limited, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Urinary Tract Infections appearing as the primary indexed condition, and to 2 interventions - of which Amoxicillin/clavulanate is the first listed.
NCT05584657 reports 20 study locations spanning 4 distinct geographic areas - top geographies include California, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT05584657 about?
NCT05584657 is a clinical study titled "Oral Sulopenem Versus Amoxicillin/Clavulanate for Uncomplicated Urinary Tract Infection in Adult Women". Study 310 is a clinical study which compares the effectiveness of oral sulopenem versus oral amoxicillin/clavulanate for the treatment of adult women with uncomplicated urinary tract infection.
What is the current status of trial NCT05584657?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,229 participants. The study started on 2022-10-18. Estimated completion is 2023-11-21.
What conditions does trial NCT05584657 study?
This clinical trial studies the following conditions: Urinary Tract Infections, Cystitis.
What interventions are being tested in trial NCT05584657?
The interventions under investigation include: Amoxicillin/clavulanate (DRUG), Sulopenem etzadroxil/probenecid (DRUG).
Who is sponsoring clinical trial NCT05584657?
This trial is sponsored by Iterum Therapeutics, International Limited, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05584657 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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