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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Clostridium Difficile Infection

Treatments: Drug: Placebo; Drug: Antibacterial drug treatment (ABD); Biological: Bezlotoxumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03182907

2017-000070-11 (EudraCT Number)

MK-6072-001 (Other Identifier)

6072-001

Details and patient eligibility

About

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.

Full description

Historical adult pharmacokinetic data is from NCT01241552 and NCT01513239.

Enrollment: 148 patients

Sex: All

Ages: 1 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At screening has suspected or confirmed Clostridium difficile infection (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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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148 participants in 2 patient groups, including a placebo group

Bezlotoxumab

Experimental group

Description:

Participants receive 10 mg of bezlotoxumab per kg body weight via a single 60-minute (±10 minutes) intravenous (IV) infusion on Day 1. Additionally, participants receive background antibacterial drug treatment (ABD) for 10-21 days per institutional guidelines, at the investigator's discretion. Dose may then be changed based on results from initial 12 participants.

Treatment:

Drug: Antibacterial drug treatment (ABD)

Biological: Bezlotoxumab

Placebo

Placebo Comparator group

Description:

Participants receive placebo for bezlotoxumab consisting of either 0.9% sodium chloride or 5% dextrose via a single 60-minute (±10 minutes) IV infusion on Day 1. Additionally, participants receive background ABD for 10-21 days per institutional guidelines, at the investigator's discretion.

Treatment:

Drug: Antibacterial drug treatment (ABD)

Drug: Placebo