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

PHASE2CompletedINTERVENTIONAL
Enrollment

302

Participants

Timeline

Start Date

May 16, 2012

Primary Completion Date

July 28, 2015

Study Completion Date

July 28, 2015

Conditions
Urinary Tract InfectionsPyelonephritis
Interventions
DRUG

Relebactam 250 mg

Participants randomized to receive relebactam 250 mg will be administered a 250 mg dose of relebactam IV in a blinded fashion once every 6 hours with each dose infused over a 30-minute interval.

DRUG

Relebactam 125 mg

Participants randomized to receive relebactam 125 mg will be administered a 125 mg dose of relebactam IV in a blinded-treatment fashion once every 6 hours with each dose infused over a 30-minute interval.

DRUG

imipenem/cilastatin 500 mg

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

Placebo to relebactam

Participants randomized to receive imipenem/cilastatin alone will receive a placebo-matching infusion of IV normal saline (0.9%) once every 6 hours.

DRUG

Ciprofloxacin

After at least 96 hours of IV treatment, participants may be switched, at the discretion of the investigator, to 500 mg ciprofloxacin, administered orally, twice daily

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT01505634 - Safety, Tolerability, and Efficacy of MK-7655 (Relebactam) + Imipenem/Cilastatin Versus Imipenem/Cilastatin Alone for Treating Complicated Urinary Tract Infection (cUTI) (MK-7655-003) | Biotech Hunter | Biotech Hunter