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Oral Sulopenem-etzadroxil/Probenecid Versus Ciprofloxacin for Uncomplicated Urinary Tract Infection in Adult Women
NCT03354598 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03354598 reports 20 study locations spanning 5 distinct geographic areas — top geographies include Florida, California, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03354598?
The interventions under investigation include: Ciprofloxacin (DRUG), Sulopenem-Etzadroxil/Probenecid (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03354598?
This trial is sponsored by Iterum Therapeutics, International Limited, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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