drugset / Trial / NCT02218372
A Study to Investigate the Safety and Efficacy of Fidaxomicin (Oral Suspension or Tablets) and Vancomycin (Oral Liquid or Capsules) in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD)
RandomizedParallel-groupSingle-blindTreatment
Summary
The purpose of this study was to investigate the clinical response to fidaxomicin oral suspension or tablets and vancomycin oral liquid or capsules in pediatric participants with Clostridium difficile-associated diarrhea (CDAD). It also investigated the recurrence/sustained clinical response to and safety of fidaxomicin and vancomycin, as well as acceptance of the fidaxomicin oral suspension formulation.
Timeline
- Start
- 2015-01-09
- Primary completion
- 2018-03-07
- Completion
- 2018-03-07
Publications
- Wolf J, Kalocsai K, Fortuny C, Lazar S, Bosis S, Korczowski B, Petit A, Bradford D, Croos-Dabrera R, Incera E, Melis J, van Maanen R. 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). Clin Infect Dis. 2020 Dec 17;71(10):2581-2588. doi: 10.1093/cid/ciz1149.
- Borali E, De Giacomo C. Clostridium Difficile Infection in Children: A Review. J Pediatr Gastroenterol Nutr. 2016 Dec;63(6):e130-e140. doi: 10.1097/MPG.0000000000001264.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fidaxomicin | Other / unclassified | 32 mg/kg | Oral |
| Subject | Fidaxomicin | Other / unclassified | 200 mg | Oral |
| Subject | Fidaxomicin | Other / unclassified | 400 mg | Oral |
| Comparator | Vancomycin | Other / unclassified | 40 mg/kg | Oral |
| Comparator | Vancomycin | Other / unclassified | 125 mg | Oral |
| Comparator | Vancomycin | Other / unclassified | 500 mg | Oral |