A Study of MK-6072 and MK-3415A in Participants Receiving Antibiotic Therapy for Clostridium Difficile Infection (MK-3415A-002)

PHASE3CompletedINTERVENTIONAL
Enrollment

1,203

Participants

Timeline

Start Date

February 1, 2012

Primary Completion Date

May 22, 2015

Study Completion Date

May 22, 2015

Conditions
Clostridium Difficile Infection
Interventions
BIOLOGICAL

MK-6072

Single IV infusion of MK-6072 (10 mg/kg of monoclonal antibody to C. difficile Toxin B)

BIOLOGICAL

MK-3415A

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

BIOLOGICAL

Placebo

Single IV infusion of normal saline (0.9% sodium chloride)

DRUG

SOC

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 metronidazole, 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

NCT01513239 - A Study of MK-6072 and MK-3415A in Participants Receiving Antibiotic Therapy for Clostridium Difficile Infection (MK-3415A-002) | Biotech Hunter | Biotech Hunter