Bezlotoxumab (MK-6072) Versus Placebo in Children With Clostridium Difficile Infection (CDI) (MK-6072-001)
Bezlotoxumab (MK-6072) Versus Placebo in Children With Clostridium Difficile Infection (CDI) (MK-6072-001)
The primary objectives of this study are to evaluate the pharmacokinetics (PK), safety, and
 tolerability of bezlotoxumab in children aged 1 to <18 years of age with a confirmed
 diagnosis of Clostridium difficile infection (CDI) who are receiving antibacterial drug
 treatment. The primary hypothesis is that the area under the concentration-time curve from 0
 to infinity (AUC0-inf) of bezlotoxumab after treatment of pediatric participants with
 bezlotoxumab is similar when compared to the AUC0-inf of bezlotoxumab after treatment of
 adults with bezlotoxumab,
Inclusion Criteria:

 -  At screening has suspected or confirmed CDI, and is receiving or is planning to
 receive a 10- to 21-day course of antibacterial drug treatment for CDI

 -  At study infusion has a diagnosis of CDI confirmed by a diagnostic assay which detects
 the presence of C. difficile toxin in stool, and is still receiving antibacterial drug
 treatment for CDI.

 -  Female is not pregnant, and not breastfeeding; but if of childbearing potential agrees
 to follow contraceptive guidance during the treatment period and for at least 12 weeks
 after the last dose of study treatment

 -  Participant and/or parent or caregiver must be able to read, understand, and complete
 the daily diary

 Exclusion Criteria:

 -  Has an uncontrolled chronic diarrheal illness

 -  Has a known hypersensitivity to bezlotoxumab, its active substance and/or any of its
 excipients

 -  At randomization, their planned course of antibacterial drug treatment for CDI is
 longer than 21 days

 -  At screening has received any listed prohibited prior and concomitant treatments and
 procedures

 -  Has previously participated in this study, has previously received bezlotoxumab, has
 received an experimental monoclonal antibody against C. difficile toxin B, or has
 received a vaccine directed against C. difficile or its toxins.

 -  Has received an investigational study agent within the previous 30 days, or is
 currently participating in or scheduled to participate in any other clinical study
 with an investigational agent during the 12-week study period