NCT03182907

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

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 148 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 1 Year – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Historical adult pharmacokinetic data is from NCT01241552 and NCT01513239.

Conditions

• Clostridium Difficile Infection

Interventions

Type	Name	Description
BIOLOGICAL	Bezlotoxumab	A single intravenous (IV) infusion of 10 mg of bezlotoxumab per kg body weight. Dose may then be changed based on results from initial 12 participants.
DRUG	Placebo	A single IV infusion of placebo for bezlotoxumab consisting of either 0.9% sodium chloride or 5% dextrose.
DRUG	Antibacterial drug treatment (ABD)	ABD will be administered for 10-21 days including the duration of ABD prior to the screening visit, during the screening period, and after the infusion of study treatment, per institutional guidelines, at the investigator's discretion. ABD is defined as the receipt of oral metronidazole, oral vancomycin, intravenous (IV) metronidazole concurrent with oral vancomycin, oral fidaxomicin, or oral fidaxomicin concurrent with IV metronidazole.

Timeline

• Start date: 2018-03-27
• Primary completion: 2022-05-12
• Completion: 2022-05-12
• First posted: 2017-06-09
• Last updated: 2023-07-27
• Results posted: 2023-06-07

Locations

75 sites across 17 countries: United States, Argentina, Brazil, Colombia, Czechia, Germany, Hungary, Malaysia, Mexico, Norway, Poland, Portugal, Romania, South Africa, Spain, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study