A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of a Single Infusion of MK-6072 (Human Monoclonal Antibody to Clostridium difficile toxin B) and MK-3415A (Human Monoclonal Antibodies to Clostridium difficile toxin A and toxin B) in Patients Receiving Antibiotic Therapy for Clostridium difficile Infection
MK-3415 (fully human monoclonal antibody to toxin A only) will not be tested alone in this study but will be used in combination with MK-6072 to make up MK-3415A (the combination of fully human monoclonal antibody to C. difficile toxin A [MK-3415] and fully human monoclonal antibody to C. difficile toxin B [MK-6072]. A separate Phase III study (Protocol 001, also known as MODIFY I) is evaluating the efficacy and safety of MK-3415. The primary goal of this clinical program is to show that a single intravenous infusion of MK-3415A (10 mg/kg of each monoclonal antibody to C. difficile toxin A [MK-3415] and toxin B [MK-6072]) reduces recurrence of C. difficile infection (CDI).
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