Phase 3 N=148 Randomized Triple-blind Prevention

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

Clostridium Difficile Infection

Bottom Line

View on ClinicalTrials.gov: NCT03182907 ↗

Enrolled (actual)

148

Serious AEs

60.1%

Results posted

Jun 2023

Primary outcome: Primary: Area Under the Concentration-Time Curve of Bezlotoxumab From Time 0 to Infinity (AUC0-inf) — 56100; 43200 hr*ug/mL

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Bezlotoxumab (Biological); Placebo (Drug); Antibacterial drug treatment (ABD) (Drug)
Age: Pediatric · 1+ yrs
Sex: All
Sponsor: Merck Sharp & Dohme LLC
Primary completion: May 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Area Under the Concentration-Time Curve of Bezlotoxumab From Time 0 to Infinity (AUC0-inf)	56100; 43200	—
PRIMARY Percentage of Participants Who Experienced an Adverse Event (AE)	88.8; 94.4	—
PRIMARY Percentage of Participants Who Discontinued Study Due to an AE	0; 0	—
SECONDARY Percentage of Participants Who Had a Clostridium Difficile Infection (CDI) Recurrence	11.2; 14.7	= 0.5701
SECONDARY Percentage of Participants Who Had a Sustained Clinical Response (SCR)	83.7; 82.9	= 0.9165
SECONDARY Percentage of High-Risk Participants Who Experienced a CDI Recurrence	12.1; 15.2	= 0.6542
SECONDARY Percentage of High-Risk Participants Who Experienced a SCR	82.5; 82.4	= 0.9873
SECONDARY Percentage of Participants Who Experienced One or More Infusion Related Reaction	0.93; 2.78	—
SECONDARY Percentage of Participants Who Had Positive Antibodies to Bezlotoxumab	2.4; 1.7	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03182907). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.