Sulopenem Followed by Sulopenem-etzadroxil/Probenecid vs Ertapenem Followed by Cipro for Complicated UTI in Adults

Phase 3 Completed 1395 enrolled Iterum Therapeutics, International Limited

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a prospective, phase 3, randomized, multicenter, double-blind, double-dummy study to compare the efficacy and safety of sulopenem followed by sulopenem-etzadroxil/probenecid versus ertapenem followed by ciprofloxacin for the treatment of complicated urinary tract infections (cUTI) in adults.

Timeline

Start: 2018-09-18
Primary completion: 2019-12-14
Completion: 2019-12-14

Publications

Dunne MW, Aronin SI, Das AF, Akinapelli K, Breen J, Zelasky MT, Puttagunta S. Sulopenem for the Treatment of Complicated Urinary Tract Infections Including Pyelonephritis: A Phase 3, Randomized Trial. Clin Infect Dis. 2023 Jan 6;76(1):78-88. doi: 10.1093/cid/ciac704.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Amoxicillin	Other / unclassified	500 mg	Oral
Comparator	Ciprofloxacin	Small molecule	500 mg	Oral
Comparator	Ertapenem	Small molecule	1000 mg	Intravenous
Subject	Sulopenem	Small molecule	1000 mg	Intravenous
Subject	Sulopenem-Etzadroxil/Probenecid	Unknown	500 mg	Oral

Sulopenem Followed by Sulopenem-etzadroxil/Probenecid vs Ertapenem Followed by Cipro for Complicated UTI in Adults

Summary

Timeline

Publications

Drugs

Indications