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

Completed · Phase 3 · Has a placebo group

Conditions studied: Clostridium Difficile Infection

In brief

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.

Key facts

Study ID

NCT03182907

Run by

Merck Sharp & Dohme LLC

People needed

148

Starts

2018-03-27

Expected to finish

2022-05-12

Last updated by the study team

2023-07-27

Who can join

Age: 1 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UCSF Medical Center ( Site 0049) — San Francisco, California, United States
• Children's Hospital - Colorado ( Site 0013) — Aurora, Colorado, United States
• Children's Center for Digestive Healthcare ( Site 0052) — Atlanta, Georgia, United States
• University of Chicago ( Site 0019) — Chicago, Illinois, United States
• Our Lady of the Lake Hospital ( Site 0007) — Baton Rouge, Louisiana, United States
• The Johns Hopkins Rubenstein Child Health Building ( Site 0034) — Baltimore, Maryland, United States
• Tufts Medical Center-Floating Hospital for Children ( Site 0046) — Boston, Massachusetts, United States
• Mayo Clinic - Rochester ( Site 0004) — Rochester, Minnesota, United States
• Washington University ( Site 0037) — St Louis, Missouri, United States
• Columbia University Medical Center/ MSCHONY ( Site 0042) — New York, New York, United States
• SUNY Upstate Medical Center, University Hospital ( Site 0027) — Syracuse, New York, United States
• Montefiore Einstein Center ( Site 0041) — The Bronx, New York, United States
• Duke University Health System ( Site 0025) — Durham, North Carolina, United States
• Cincinnati Children's Hospital Medical Center ( Site 0024) — Cincinnati, Ohio, United States
• University Hospitals Cleveland Medical Center ( Site 0029) — Cleveland, Ohio, United States
• St. Jude Children's Research Hospital ( Site 0050) — Memphis, Tennessee, United States
• Vanderbilt University Medical Center ( Site 0022) — Nashville, Tennessee, United States
• The Children's Hospital of San Antonio ( Site 0009) — San Antonio, Texas, United States
• Primary Children's Hospital ( Site 0001) — Salt Lake City, Utah, United States
• Seattle Childrens Hospital ( Site 0028) — Seattle, Washington, United States
• Hospital Italiano de Buenos Aires. ( Site 2103) — Caba, Buenos Aires, Argentina
• Hospital Privado de Cordoba ( Site 2102) — Córdoba, Argentina
• Santa Casa de Misericordia de Belo Horizonte ( Site 0208) — Belo Horizonte, Minas Gerais, Brazil
• Hospital de Clinicas da Universidade Federal do Parana ( Site 0203) — Curitiba, Paraná, Brazil
• Children's Hospital - Los Angeles ( Site 0021) — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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