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

Phase 3 Completed 2229 enrolled Iterum Therapeutics, International Limited

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2022-10-18
Primary completion: 2023-11-03
Completion: 2023-11-21

Outcome

Met primary endpoint

paper difference, 5.4 percentage points; 95% confidence interval [CI], -0.8 to 11.5), meeting criteria for noninferiority. PMID 40552968 ↗

Publications

Puttagunta S, Aronin SI, Gupta J, Das AF, Gupta K, Dunne MW. Sulopenem versus Amoxicillin/Clavulanate for the Treatment of Uncomplicated Urinary Tract Infection. NEJM Evid. 2025 Jul;4(7):EVIDoa2400414. doi: 10.1056/EVIDoa2400414. Epub 2025 Jun 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Amoxicillin/clavulanate	Unknown	—	Oral
Subject	Probenecid	Small molecule	500 mg	Oral
Subject	sulopenem etzadroxil	Small molecule	500 mg	Oral