Bezlotoxumab (MK-6072) versus placebo in children with CDI: MODIFY III
Research type
Research Study
Full 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)
IRAS ID
234168
Contact name
Saul Faust
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2017-000070-11
Duration of Study in the UK
3 years, 0 months, 30 days
Research summary
Research Summary
Clostridium difficile infection (CDI) is caused by a bacterium, C. difficile, infecting the bowel and can cause symptoms such as fever and diarrhoea. Over the last 10-15 years, there has been a global increase in frequency severity, complication rate and mortality in adults with CDI.
The standard treatment for CDI is oral antibiotics. However, data has shown that the rate of CDI recurring can be up to 38%. Recurrence of the infection could lead to serious bowel problems.
Bezlotoxumab (MK-6072) is a fully human monoclonal antibody that binds to and neutralizes C. difficile toxin B (produced by the bacteria), thereby preventing new/further toxin damage to the gut and thus preventing infection recurrence. In clinical trials in adults with CDI, bezlotoxumab significantly reduced CDI recurrence compared to placebo.
Bezlotoxumab is currently approved for use in adults for the reduction or prevention of CDI recurrence in patients who are receiving antibacterial drug treatment and are at a high risk for CDI recurrence. Aside from bezlotoxumab, there are no other biological agents or drugs licensed to prevent CDI recurrences; bezlotoxumab is not approved for use in children. In the context of the worsening CDI epidemic, there remains an unmet medical need for therapies to prevent CDI recurrence in children.
This Phase 3, placebo-controlled study will last approximately 36 months and will recruit approximately 192 participants. The study will assess the pharmacokinetics, safety, tolerability and effectiveness of a single infusion of Bezlotoxumab in children, aged between 1 to 18 Years, who are receiving antibacterial drug treatment for CDI. Participants will be assigned to cohorts based on age (Cohort 1 (12-18 years) will enrol first and Cohort 2 (1-<12 years) will commence later).
The study is funded by Merck Sharp & Dohme Limited and will take place at two UK study centres
Summary of Results
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REC name
East of England - Cambridge South Research Ethics Committee
REC reference
19/EE/0155
Date of REC Opinion
12 Jun 2019
REC opinion
Further Information Favourable Opinion