Clostridium Difficile Infection Clinical Trial
Official title:
A Prospective, Multicenter Study to Investigate the Pharmacokinetics, Safety, and Efficacy of Cadazolid Versus Vancomycin in Pediatric Subjects With Clostridium Difficile-associated Diarrhea
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.
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.
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