NCT01987895

Efficacy and Safety of Cadazolid Versus Vancomycin in Subjects With Clostridium Difficile - Associated Diarrhea

A Multi-center, Randomized, Double-blind Study to Compare the Efficacy and Safety of Cadazolid Versus Vancomycin in Subjects With Clostridium Difficile-associated Diarrhea (CDAD)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 632 (actual)
• Sponsor: Actelion · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical study is conducted to assess the efficacy of cadazolid compared to vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD).

Detailed description

Subjects selected to participate in the study are treated either with cadazolid or vancomycin for 10 days. At the end of treatment, clinical cure is assessed; subjects are then followed-up to assess any disease recurrence.

Conditions

• Clostridium Difficile Infection

Interventions

Type	Name	Description
DRUG	Cadazolid	Cadazolid 250 mg as oral suspension twice daily.
DRUG	Vancomycin	Vancomycin 125 mg as oral capsules 4 times daily.
DRUG	Cadazolid-matching placebo	Placebo matching cadazolid and administered orally twice daily
DRUG	Vancomycin-matching placebo	Placebo capsules matching vancomycin and administered orally 4 times per day

Timeline

• Start date: 2014-03-27
• Primary completion: 2017-02-26
• Completion: 2017-03-24
• First posted: 2013-11-20
• Last updated: 2025-02-04
• Results posted: 2018-05-04

Regulatory

• FDA-regulated drug study