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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.

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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

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

FieldValue
Enrollment Target 1,671 participants
Start Date 2018-08-01
Est. Completion 2020-01-20
Phase Phase 3

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.