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


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Verified June 2017 by Merck Sharp & Dohme Corp.

Sponsor:

Information provided by (Responsible Party):

Merck Sharp & Dohme Corp.

ClinicalTrials.gov Identifier:

NCT03182907

First received: June 8, 2017

Last updated: June 8, 2017

Last verified: June 2017

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

Clostridium Difficile Infection Biological: Bezlotoxumab
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator
Primary Purpose: Prevention
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)

Primary Outcome Measures:

  • Concentration time curve of bezlotoxumab [ Time Frame: Day 1 (2 hrs after infusion), Days 10, 29, 57, and 85 ]

    Area under the concentration time curve from time 0 to infinity (AUC0-inf) of serum bezlotoxumab

  • Adverse events (AEs) [ Time Frame: Up to Day 90 ]

    Percentage of participants experiencing AEs

  • Discontinuing medication [ Time Frame: Day 1 ]

    Percentage of participants discontinuing study medication due to an AE

Secondary Outcome Measures:

  • Clostridium difficile infection (CDI) recurrence [ Time Frame: Up to Week 12 ]

    Percentage of participants who have a CDI recurrence within 12 weeks of study medication infusion.

  • Sustained clinical response [ Time Frame: Up to Week 12 ]

    Percentage of participants with sustained clinical response within 12 weeks of study medication infusion.

  • CDI recurrence and sustained clinical response [ Time Frame: Up to Week 12 ]

    Percentage of participants who have a CDI recurrence and who achieve sustained clinical response within 12 weeks of study medication infusion in participants at high risk of CDI recurrence.

  • Infusion-related reactions [ Time Frame: Up to 24 hours ]

    Percentage of participants experiencing 1 or more infusion-related reactions within 24 hours following the start of study medication infusion.

  • Positive antibodies to bezlotoxumab [ Time Frame: Up to Week 12 ]

    Percentage of participants with treatment-emergent positive antibodies to bezlotoxumab in serum through 12 weeks following a single dose of bezlotoxumab.

Estimated Enrollment: 216
Anticipated Study Start Date: December 1, 2017
Estimated Study Completion Date: May 9, 2022
Estimated Primary Completion Date: May 9, 2022 (Final data collection date for primary outcome measure)
Experimental: 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.

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.

Other Name: MK-6072

Placebo Comparator: Placebo

A single IV infusion of placebo for bezlotoxumab consisting of either 0.9% sodium chloride or 5% dextrose

Drug: Placebo

A single IV infusion of placebo for bezlotoxumab consisting of either 0.9% sodium chloride or 5% dextrose.

Ages Eligible for Study:   1 Year to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • At screening has suspected or confirmed 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
  • 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03182907

Merck Sharp & Dohme Corp.

Study Director: Medical Director Merck Sharp & Dohme Corp.

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT03182907     History of Changes
Other Study ID Numbers: 6072-001
2017-000070-11 ( EudraCT Number )
Study First Received: June 8, 2017
Last Updated: June 8, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Infection
Communicable Diseases

ClinicalTrials.gov processed this record on June 09, 2017