NCT03105479

Comparison of Cadazolid Versus Vancomycin in Children With Clostridium Difficile-associated Diarrhea (CDAD)

A Prospective, Multicenter Study to Investigate the Pharmacokinetics, Safety, and Efficacy of Cadazolid Versus Vancomycin in Pediatric Subjects With Clostridium Difficile-associated Diarrhea

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Actelion · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Cadazolid has demonstrated activity against a bacteria named Clostridium difficile in animal studies. The results of a first study conducted in adult patients have suggested efficacy of the new antibiotic, cadazolid, in the treatment of diarrhea caused by this bacteria. This is the first study of cadazolid in children. The overall purpose of this study is to provide reassurance on the safety and efficacy of cadazolid in children suffering from infection due to Clostridium difficile.

Detailed description

This multicenter, study will be run into two parts. Both parts will be run in consecutive age cohorts, starting from the oldest age categories(12 to \< 18 years old) to the youngest (birth to \< 3 months). * Part A is an open-label, dose finding part to be conducted in at least 24 subjects. * Part B follows a randomized, assessor-blinded, parallel-group design with vancomycin used as an active comparator. Part B will be conducted in about 176 children. In both parts, the treatment period will be 10 days and will be followed by a Follow-up period of 28-32 days.

Conditions

• Clostridium Difficile Infection

Interventions

Type	Name	Description
DRUG	Cadazolid	Granules for oral suspension to be administered twice daily
DRUG	Vancomycin capsule	Capsule containing 125 mg of vancomycin to be administered orally 4 times a day
DRUG	Vancomycin solution	Vancomycin powder to be administered as oral solution at a dose of 40 mg/kg/day, 3 to 4 times a day

Timeline

• Start date: 2017-04-14
• Primary completion: 2018-04-17
• Completion: 2018-04-17
• First posted: 2017-04-10
• Last updated: 2025-07-08
• Results posted: 2019-04-03

Locations

20 sites across 9 countries: United States, Belgium, Canada, Czechia, Hungary, Italy, Poland, Romania, Spain

Regulatory

• FDA-regulated drug study