drugset / Trial / NCT03105479

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

NCT03105479 ↗

Phase 2/3 Terminated 1 enrolled Actelion
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2017-04-14
Primary completion
2018-04-17
Completion
2018-04-17

Outcome

Outcome not reported

Stopped: “Study suspended in October 2017 and terminated April 17, 2018 after decision to discontinue the study drug development”

Drugs

EvaluationDrugModalityDoseRoute
Subject Cadazolid Small molecule 500 mg Oral
Comparator Vancomycin Other / unclassified 40 mg/kg Oral
Comparator Vancomycin Other / unclassified 125 mg Oral