Safety and Efficacy of Fidaxomicin and Vancomycin in Children and Adolescents with Clostridioides (Clostridium) difficile Infection: A Phase 3, Multicenter, Randomized, Single-blind Clinical Trial (SUNSHINE).
Joshua Wolf, Krisztina Kalocsai, Claudia Fortuny, Stefan Lazar, Samantha Bosis, Bartosz Korczowski, Arnaud Petit, Daniel Bradford, Rodney Croos-Dabrera, Elodie Incera, Joost Melis, Rob van Maanen
Clin Infect Dis | Published : 2020
BACKGROUND: Fidaxomicin, a narrow-spectrum antibiotic approved for Clostridioides (Clostridium) difficile infection (CDI) in adults, is associated with lower rates of recurrence than vancomycin; however, pediatric data are limited. This multicenter, investigator-blind, phase 3, parallel-group trial assessed the safety and efficacy of fidaxomicin in children. METHODS: Patients aged <18 years with confirmed CDI were randomized 2:1 to 10 days of treatment with fidaxomicin (suspension or tablets, twice daily) or vancomycin (suspension or tablets, 4 times daily). Safety assessments included treatment-emergent adverse events. The primary efficacy end point was confirmed clinical response (CCR), 2 ..View full abstract