CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,229 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/NCT05584657
NCT05584657Phase 3Completed

A Prospective, Phase 3, Randomized, Multi-center, Double-blind Study of the Efficacy, Tolerability, and Safety of Oral Sulopenem Etzadroxil/Probenecid Versus Oral Amoxicillin/Clavulanate for Treatment of Uncomplicated Urinary Tract Infections (uUTI) in Adult Women

Iterum Therapeutics, International Limited·interventional·Posted Oct 18, 2022·Updated Nov 20, 2024

In Brief

A Phase 3 clinical trial evaluating Sulopenem etzadroxil/probenecid and Amoxicillin/clavulanate for Urinary Tract Infections and Cystitis. Completed, enrolled 2,229 participants across 167 sites.

Detailed 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.

Study Details

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

Timeline

Phase 3CompletedFinished
2023202420252026
First PostedOct 18, 2022
Enrollment StartOct 18, 2022
Primary CompletionNov 3, 2023
Study CompletionNov 21, 2023
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 3.7 years ago

Interventions

Sulopenem etzadroxil/probeneciddrug

Oral sulopenem twice daily for 5 days

Amoxicillin/clavulanatedrug

Oral Augmentin twice daily for 5 days