Bezlotoxumab (MK-6072) Versus Placebo in Children With Clostridium Difficile Infection (CDI) (MK-6072-001)
Condition: Clostridium Difficile Infection
MeSH terms: Infections; Communicable Diseases; Clostridium Infections
Intervention: Bezlotoxumab; Placebo; Antibacterial drug treatment (ABD)
Intervention description: 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.; A single IV infusion of placebo for bezlotoxumab consisting of either 0.9% sodium chloride or 5% dextrose.; 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.
Intervention MeSH terms: Anti-Bacterial Agents
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 148.0
Sex: All
Minimum age: 1 Year
Maximum age: 17 Years
Healthy volunteers: No

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