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NCT03357614 · ClinicalTrials.gov registry record · Phase 3
Sulopenem Followed by Sulopenem-etzadroxil/Probenecid vs Ertapenem Followed by Cipro for Complicated UTI in Adults
A Phase 3 study of Complicated Urinary Tract Infections, sponsored by Iterum Therapeutics, International Limited.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,395
- Enrollment target
- 20
- Study locations
NCT03357614 is a Phase 3 study of Complicated Urinary Tract Infections that has completed, run by Iterum Therapeutics, International Limited. The registered enrollment target is 1,395 participants. The trial reports 20 study locations across 10 states.
The verdict
NCT03357614, a Phase 3 study of Complicated Urinary Tract Infections, has completed, sponsored by Iterum Therapeutics, International Limited.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,395 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a prospective, phase 3, randomized, multicenter, double-blind, double-dummy study to compare the efficacy and safety of sulopenem followed by sulopenem-etzadroxil/probenecid versus ertapenem followed by ciprofloxacin for the treatment of complicated urinary tract infections (cUTI) in adults.
Conditions Studied
Interventions
- DRUG Ciprofloxacin
- DRUG Amoxicillin-clavulanate
- DRUG Ertapenem
- DRUG Sulopenem-Etzadroxil/Probenecid
- DRUG Sulopenem
Study Locations (20)
California
- Medical Facility - Bellflower
- Medical Facility - Chula Vista
- Medical Facility - La Mesa
- Medical Facility - La Palma
- Medical Facility - Torrance
Other
- Medical Facility - Kohtla-Järve
- Medical Facility - Tallinn
- Medical Facility - Võru
- Medical Facility - Tbilisi
- Medical Facility - Tbilisi
Ohio
- Medical Facility - Columbus
- Medical Facility - Columbus
Texas
- Medical Facility - Dallas
- Medical Facility - Houston
Florida
- Medical Facility - Miami Lakes
Georgia
- Medical Facility - Columbus
Idaho
- Medical Facility - Idaho Falls
Massachusetts
- Medical Facility - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,395 participants |
| Start Date | 2018-09-18 |
| Est. Completion | 2019-12-14 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03357614
The ClinicalTrials.gov registry entry for NCT03357614 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,395 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 Complicated Urinary Tract Infections appearing as the primary indexed condition, and to 5 interventions - of which Ciprofloxacin is the first listed.
NCT03357614 reports 20 study locations spanning 10 distinct geographic areas - top geographies include California, Other, Ohio.
Frequently Asked Questions
What is clinical trial NCT03357614 about?
NCT03357614 is a clinical study titled "Sulopenem Followed by Sulopenem-etzadroxil/Probenecid vs Ertapenem Followed by Cipro for Complicated UTI in Adults". This is a prospective, phase 3, randomized, multicenter, double-blind, double-dummy study to compare the efficacy and safety of sulopenem followed by sulopenem-etzadroxil/probenecid versus ertapenem followed by ciprofloxacin for the treatment of complicated urinary tract infections (cUTI) in adults.
What is the current status of trial NCT03357614?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,395 participants. The study started on 2018-09-18. Estimated completion is 2019-12-14.
What conditions does trial NCT03357614 study?
This clinical trial studies the following conditions: Complicated Urinary Tract Infections.
What interventions are being tested in trial NCT03357614?
The interventions under investigation include: Ciprofloxacin (DRUG), Amoxicillin-clavulanate (DRUG), Ertapenem (DRUG), Sulopenem-Etzadroxil/Probenecid (DRUG), Sulopenem (DRUG).
Who is sponsoring clinical trial NCT03357614?
This trial is sponsored by Iterum Therapeutics, International Limited, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03357614 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Idaho, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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