Efficacy and Safety of Imipenem+Cilastatin/Relebactam (MK-7655A) Versus Colistimethate Sodium+Imipenem+Cilastatin in Imipenem-Resistant Bacterial Infection (MK-7655A-013)

PHASE3CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

August 21, 2015

Primary Completion Date

September 18, 2017

Study Completion Date

September 18, 2017

Conditions
Bacterial Infections
Interventions
DRUG

Imipenem+Cilastatin/Relebactam

Imipenem+Cilastatin/Relebactam 200/100 mg to 500/250 mg, depending on renal function, IV infusion once every 6 hours

DRUG

Colistimethate sodium (CMS)

Colistimethate base activity 300 mg (\~720 mg CMS) IV infusion loading dose, followed by colistimethate base activity 75 mg to 150 mg (\~180 to 360 mg CMS), depending on renal function, once every 12 hours

DRUG

Imipenem+Cilastatin

Imipenem+cilastatin 200 mg to 500 mg, depending on renal function, IV infusion once every 6 hours

DRUG

Placebo to CMS

Placebo to CMS IV infusion once every 12 hours

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT02452047 - Efficacy and Safety of Imipenem+Cilastatin/Relebactam (MK-7655A) Versus Colistimethate Sodium+Imipenem+Cilastatin in Imipenem-Resistant Bacterial Infection (MK-7655A-013) | Biotech Hunter | Biotech Hunter