Bezlotoxumab (MK-6072) Versus Placebo in Children With Clostridium Difficile Infection (CDI) (MK-6072-001)
Status:
Recruiting
Trial end date:
2022-05-27
Target enrollment:
Participant gender:
Summary
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,