1,203
Participants
Start Date
February 1, 2012
Primary Completion Date
May 22, 2015
Study Completion Date
May 22, 2015
MK-6072
Single IV infusion of MK-6072 (10 mg/kg of monoclonal antibody to C. difficile Toxin B)
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)
Placebo
Single IV infusion of normal saline (0.9% sodium chloride)
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.
Merck Sharp & Dohme LLC
INDUSTRY