Conditions: Clostridium Difficile Infection
Keywords: Clostridium difficile recurrent Clostridium difficile vancomycin metronidazole monoclonal antibody Clostridium difficile infection (CDI)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1452
Healthy volunteers: no

Brief summary:
This study will investigate whether: 1) treatment with MK-3415A in addition to standard of care (SOC) antibiotic therapy will decrease Clostridium difficile infection (CDI) recurrence as compared to treatment with MK-6072 or MK-3415, 2) treatment with MK-3415A, MK-6072, or MK-3415, in addition to SOC antibiotic therapy will decrease CDI recurrence as compared to placebo, and 3) MK-3415A, MK-6072, and MK-3415 will be generally well tolerated in participants receiving SOC therapy for CDI as compared to placebo.

Detailed description:

Arms:
arm 1: Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI arm 2: Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI arm 3: Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI arm 4: Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI

Interventions: intervention 1: MK-3415 intervention 2: MK-6072 intervention 3: MK-3415A intervention 4: Placebo intervention 5: SOC
Intervention descriptions: intervention 1: A single IV infusion of MK-3415 (10 mg/kg of monoclonal antibody to Clostridium difficile Toxin A) intervention 2: A single infusion of MK-6072 (10 mg/kg of monoclonal antibody to Clostridium difficile Toxin B) intervention 3: 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) intervention 4: A single IV infusion of normal saline (0.9% sodium chloride) intervention 5: 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.

Protocol document: