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)
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)
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.
Historical adult pharmacokinetic data is from NCT01241552 and NCT01513239.
Inclusion Criteria:
Exclusion Criteria:
Baltimore, Maryland 21287, United States
Boston, Massachusetts 02111, United States
Syracuse, New York 13210, United States
Caba, Buenos Aires C1199ABB, Argentina
Belo Horizonte, Minas Gerais 30150-321, Brazil
Curitiba, Paraná 80060-900, Brazil
Santa Maria, Rio Grande do Sul 97105-900, Brazil
Plzen Lochotin, Plzeň Region 304 60, Czechia
Budapest, 1097, Hungary
Monterrey, Nuevo León 64400, Mexico
Monterrey, Nuevo León 64710, Mexico
Bergen, Vestfold 5053, Norway
Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-030, Poland
Łomianki, Masovian Voivodeship 05-092, Poland
Olsztyn, Warmian-Masurian Voivodeship 10-561, Poland
Lodz, Łódź Voivodeship 91-347, Poland
Lisbon, 1169-045, Portugal
Porto, 4200-072, Portugal
Bucharest, 030303, Romania
Stockholm, Stockholm County 17176, Sweden