CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,671 enrolled
Drug / intervention
Sulopenem-Etzadroxil/Probenecid +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03354598
NCT03354598Phase 3Completed

A Prospective Phase 3 Randomized Multi-center Double-blind Study of Efficacy Tolerability & Safety of Oral Sulopenem-etzadroxil/Probenecid vs Ciprofloxacin for Treatment of Uncomplicated Urinary Tract Infections (uUTI) in Adult Women

Iterum Therapeutics, International Limited·interventional·Posted Nov 28, 2017·Updated Jan 12, 2021

In Brief

A Phase 3 clinical trial evaluating Sulopenem-Etzadroxil/Probenecid and Ciprofloxacin for Uncomplicated Urinary Tract Infections. Completed, enrolled 1,671 participants across 60 sites.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedNov 28, 2017
Enrollment StartAug 1, 2018
Primary CompletionJan 16, 2020
Study CompletionJan 20, 2020
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 8.6 years ago

Interventions

Sulopenem-Etzadroxil/Probeneciddrug

Treatment of uncomplicated urinary tract infection

Ciprofloxacindrug

Treatment of uncomplicated urinary tract infection