A Study of MK-3415, MK-6072, and MK-3415A in Participants Receiving Antibiotic Therapy for Clostridium Difficile Infection (MK-3415A-001)

PHASE3CompletedINTERVENTIONAL
Enrollment

1,452

Participants

Timeline

Start Date

October 10, 2011

Primary Completion Date

December 9, 2014

Study Completion Date

December 9, 2014

Conditions
Clostridium Difficile Infection
Interventions
BIOLOGICAL

MK-3415

A single IV infusion of MK-3415 (10 mg/kg of monoclonal antibody to Clostridium difficile Toxin A)

BIOLOGICAL

MK-6072

A single infusion of MK-6072 (10 mg/kg of monoclonal antibody to Clostridium difficile Toxin B)

BIOLOGICAL

MK-3415A

A single IV infusion of MK-3415A (10 mg/kg of monoclonal antibody to Clostridium difficile Toxin A and 10mg/kg of monoclonal antibody to Clostridium difficile Toxin B)

BIOLOGICAL

Placebo

A single IV infusion of normal saline (0.9% sodium chloride)

DRUG

SOC

Standard of care (SOC) for CDI will be prescribed for 10 to 14 days and can begin on the day of study drug infusion; but the first dose must have been administered prior to or within a few hours following study drug infusion. SOC is defined as the receipt of oral metranidazole, oral vancomycin, IV metronidazole concurrent with oral vancomycin, oral fidaxomicin, or oral fidaxomicin concurrent with IV metronidazole.

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT01241552 - A Study of MK-3415, MK-6072, and MK-3415A in Participants Receiving Antibiotic Therapy for Clostridium Difficile Infection (MK-3415A-001) | Biotech Hunter | Biotech Hunter