Overview

Safety, Tolerability, and Efficacy of MK-7655 (Relebactam) + Imipenem/Cilastatin Versus Imipenem/Cilastatin Alone for Treating Complicated Urinary Tract Infection (cUTI) (MK-7655-003)

Status:
Completed
Trial end date:
2015-07-28
Target enrollment:
Participant gender:
Summary
The purpose of this study is to evaluate the efficacy, safety and tolerability of adding 125 mg or 250 mg doses of MK-7655 (relebactam) to imipenem/cilastatin in adults 18 years or older with complicated urinary tract infection (cUTI). The primary hypothesis is that the relebactam + imipenem/cilastatin treatment regimen is non-inferior to imipenem/cilastatin with respect to the proportion of participants with a favorable microbiological response at completion of intravenous (IV) study therapy.
Phase:
Phase 2
Details
Lead Sponsor:
Merck Sharp & Dohme Corp.
Treatments:
Cilastatin
Ciprofloxacin
Imipenem
MK-7655
Relebactam