NCT03357614

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

Prospective, Phase 3, Randomized, Multi-center, Double-blind, Double-dummy Study of Efficacy, Tolerability & Safety of Sulopenem Followed by Sulopenem-etzadroxil/Probenecid vs Ertapenem Followed by Cipro for Treatment of cUTI in Adults

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,395 (actual)
• Sponsor: Iterum Therapeutics, International Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Complicated Urinary Tract Infections

Interventions

Type	Name	Description
DRUG	Sulopenem	Antibiotic therapy for complicated UTI
DRUG	Sulopenem-Etzadroxil/Probenecid	Antibiotic therapy for complicated UTI
DRUG	Ertapenem	Antibiotic therapy for complicated UTI
DRUG	Ciprofloxacin	Antibiotic therapy for complicated UTI
DRUG	Amoxicillin-clavulanate	Antibiotic therapy for complicated UTI

Timeline

• Start date: 2018-09-18
• Primary completion: 2019-12-14
• Completion: 2019-12-14
• First posted: 2017-11-30
• Last updated: 2020-12-29
• Results posted: 2020-12-29

Locations

32 sites across 5 countries: United States, Estonia, Georgia, Hungary, Latvia

Regulatory

• FDA-regulated drug study