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Bezlotoxumab (MK-6072) Versus Placebo in Children With Clostridium Difficile Infection (CDI) (MK-6072-001) — MODIFY III  

Clostridium Difficile Infection Clinical Trial

Official title:
A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of a Single Infusion of Bezlotoxumab (MK-6072, Human Monoclonal Antibody to C. Difficile Toxin B) in Children Aged 1 to <18 Years Receiving Antibacterial Drug Treatment for C. Difficile Infection (MODIFY III)

Clinical Trial Summary

The primary objectives of this study are to evaluate the pharmacokinetics (PK), safety, and tolerability of bezlotoxumab (MK-6072) 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.

Clinical Trial Description

Historical adult pharmacokinetic data is from NCT01241552 and NCT01513239. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03182907
Study type Interventional
Source Merck Sharp & Dohme LLC
Contact
Status Completed
Phase Phase 3
Start date March 27, 2018
Completion date May 12, 2022
View Details
See also
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