NCT01506271

Study of the Safety, Tolerability, and Efficacy of Relebactam (MK-7655) + Imipenem/Cilastatin Versus Imipenem/Cilastatin Alone to Treat Complicated Intra-Abdominal Infection [cIAI] (MK-7655-004)

A Phase II, Randomized, Active Comparator-Controlled Clinical Trial to Study the Safety, Tolerability, and Efficacy of MK-7655 + Imipenem/Cilastatin Versus Imipenem/Cilastatin Alone in Patients With Complicated Intra-Abdominal Infection [cIAI]

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 351 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of adding 125 mg or 250 mg doses of relebactam (MK-7655) to imipenem/cilastatin in adults 18 years or older with Complicated Intra-Abdominal Infection (cIAI). The primary hypothesis is that the relebactam + imipenem/cilastatin treatment regimen is non-inferior to treatment with imipenem/cilastatin alone with respect to the percentage of participants with a favorable clinical response at completion of intravenous (IV) study therapy.

Conditions

• Intra-abdominal Infections

Interventions

Type	Name	Description
DRUG	Relebactam 250 mg	Relebactam 250 mg IV every 6 hours for a minimum of 96 hours
DRUG	Relebactam 125 mg	Relebactam 125 mg IV every 6 hours for a minimum of 96 hours
DRUG	Imipenem/cilastatin	A 500 mg dose of imipenem/cilastatin will be administered IV in an open-label fashion once every 6 hours with each dose infused over a 30-minute interval.
DRUG	Matching placebo to relebactam	Placebo-matching infusion of IV normal saline (0.9%) once every 6 hours.

Timeline

• Start date: 2012-06-01
• Primary completion: 2014-08-12
• Completion: 2014-08-12
• First posted: 2012-01-09
• Last updated: 2019-06-10
• Results posted: 2019-06-10