Efficacy and Safety of Cadazolid Versus Vancomycin in Subjects With Clostridium Difficile - Associated Diarrhea
|ClinicalTrials.gov Identifier: NCT01987895|
Recruitment Status : Completed
First Posted : November 20, 2013
Last Update Posted : December 15, 2017
|Condition or disease||Intervention/treatment||Phase|
|Clostridium Difficile Infection||Drug: Cadazolid Drug: Vancomycin Drug: Cadazolid-matching placebo Drug: Vancomycin-matching placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||632 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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)|
|Actual Study Start Date :||March 27, 2014|
|Primary Completion Date :||February 26, 2017|
|Study Completion Date :||March 24, 2017|
Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days
Cadazolid 250 mg as oral suspension twice daily.
Other Name: ACT-179811Drug: Vancomycin-matching placebo
Placebo capsules matching vancomycin and administered orally 4 times per day
Active Comparator: Vancomycin
Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days
Vancomycin 125 mg as oral capsules 4 times daily.
Other Name: VancocinDrug: Cadazolid-matching placebo
Placebo matching cadazolid and administered orally twice daily
- Clinical Cure [ Time Frame: End of Treatment (10 days after starting study drug) + 2 days ]Clinical Cure is defined as: • Resolution of Diarrhea (ROD) (≤ 3 unformed bowel movement (UBM) per day for at least 2 consecutive days) on study treatment and maintained for 2 days after EOT, AND • No additional antimicrobial treatment active against Clostridium difficile-associated diarrhea (CDAD) or fecal microbiota transplant (FMT) between first dose of study drug and 2 days after EOT (inclusive)
- Sustained Cure [ Time Frame: End of Treatment (10 days after starting study drug) + 28-32 days ]Sustained cure is defined for each subject having Clinical Cure and no recurrence
- Time to Resolution of Diarrhea [ Time Frame: Baseline to End of Treatment (10 days after starting study drug) ]The time between the first dose of study drug and Resolution of Diarrhea.
- Absolute change from baseline in clostridium difficile-associated diarrhea (CDAD) DaySyms PRO daily score [ Time Frame: Baseline to End of Treatment (10 days after starting study drug) + 2 days ]Change from baseline to End of Treatment + 2 days in CDAD Symptoms as measured by the DaySyms Patient Reported Outcome (PRO).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01987895
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|Study Director:||Anne Claire Marrast, MD||Actelion|