NCT03358576

Sulopenem Versus Ertapenem for Complicated Intra-abdominal Infection (cIAI)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 674 (actual)
• Sponsor: Iterum Therapeutics, International Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, Phase 3, randomized, multi-center, double-blind study of the efficacy, tolerability and safety of sulopenem followed by sulopenem-etzadroxil/probenecid versus ertapenem followed by ciprofloxacin-metronidazole for treatment of complicated intra-abdominal infections in adults.

Conditions

• Intra Abdominal Infections

Interventions

Type	Name	Description
DRUG	Ertapenem	Antibiotic for complicated intra-abdominal infection
DRUG	Sulopenem-Etzadroxil/Probenecid	Antibiotic for complicated intra-abdominal infection
DRUG	Ciprofloxacin	Antibiotic for complicated intra-abdominal infection
DRUG	Metronidazole	Antibiotic for complicated intra-abdominal infection
DRUG	Amoxicillin-Clavulanate	Antibiotic for complicated intra-abdominal infection
DRUG	Sulopenem	Antibiotic for complicated intra-abdominal infection

Timeline

• Start date: 2018-09-18
• Primary completion: 2019-10-02
• Completion: 2019-10-02
• First posted: 2017-11-30
• Last updated: 2020-12-01
• Results posted: 2020-12-01

Locations

42 sites across 7 countries: United States, Bulgaria, Estonia, Georgia, Hungary, Latvia, Poland

Regulatory

• FDA-regulated drug study