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)

A Phase 3, Multicenter, Investigator-blind, Randomized, Parallel Group Study to Investigate the Safety and Efficacy of Fidaxomicin Oral Suspension or Tablets Taken q12h, and Vancomycin Oral Liquid or Capsules Taken q6h, for 10 Days in Pediatric Subjects With Clostridium Difficile-associated Diarrhea

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 148 (actual)
• Sponsor: Astellas Pharma Europe B.V. · Industry
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Clostridium Difficile-associated Diarrhea (CDAD)

Interventions

Type	Name	Description
DRUG	Fidaxomicin oral suspension	Participants from birth to \< 6 years of age received weight based doses of fidaxomicin oral suspension (32 mg/kg/day with a maximum dose of 400 mg/day divided in 2 doses) 2 times daily for 10 days.
DRUG	Fidaxomicin tablets	Participants aged ≥ 6 years to \< 18 years of age received a 200 mg fidaxomicin tablet 2 times daily for 10 days.
DRUG	Vancomycin oral liquid	Participants from birth to \< 6 years of age received weight based doses of vancomycin oral liquid (40 mg/kg/day with a maximum dose of 500 mg/day divided in 4 doses) 4 times daily for 10 days.
DRUG	Vancomycin capsules	Participants aged ≥ 6 years to \< 18 years of age received a 125 mg vancomycin capsule 4 times daily for 10 days.

Timeline

• Start date: 2015-01-09
• Primary completion: 2018-03-07
• Completion: 2018-03-07
• First posted: 2014-08-18
• Last updated: 2024-11-26
• Results posted: 2018-12-07

Locations

44 sites across 10 countries: United States, Belgium, Canada, France, Germany, Hungary, Italy, Poland, Romania, Spain

Regulatory

• FDA-regulated drug study