NCT01506271View on ClinicalTrials.gov

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)

PHASE2CompletedINTERVENTIONAL
Enrollment

351

Participants

Timeline

Start Date

June 1, 2012

Primary Completion Date

August 12, 2014

Study Completion Date

August 12, 2014

Conditions
Intra-abdominal Infections
Interventions
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.

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

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) | Biotech Hunter | Biotech Hunter