NCT05584657

Oral Sulopenem Versus Amoxicillin/Clavulanate for Uncomplicated Urinary Tract Infection in Adult Women

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,229 (actual)
• Sponsor: Iterum Therapeutics, International Limited · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

IT001-310 is a Phase 3, randomized, multicenter, double-blind, double dummy, controlled study to compare oral sulopenem etzadroxil/probenecid (oral sulopenem) to oral amoxicillin/clavulanate for the treatment of adult female patients with uncomplicated urinary tract infection. Approximately 1966 adult women with uncomplicated urinary tract infection will be randomized in a 1:1 fashion to receive either oral sulopenem etzadroxil/probenecid or oral amoxicillin/clavulanate twice daily for 5 days. The primary outcome measure for efficacy evaluation will be the overall success (combined clinical and microbiologic success) on Day 12 (± 1 day)/Test of Cure (TOC).

Conditions

• Urinary Tract Infections
• Cystitis

Interventions

Type	Name	Description
DRUG	Sulopenem etzadroxil/probenecid	Oral sulopenem twice daily for 5 days
DRUG	Amoxicillin/clavulanate	Oral Augmentin twice daily for 5 days

Timeline

• Start date: 2022-10-18
• Primary completion: 2023-11-03
• Completion: 2023-11-21
• First posted: 2022-10-18
• Last updated: 2024-11-20
• Results posted: 2024-11-20

Locations

167 sites across 1 country: United States

Regulatory

• FDA-regulated drug study