Fidaxomicin Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD) (MK-5119-018)
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|ClinicalTrials.gov Identifier: NCT00314951|
Recruitment Status : Completed
First Posted : April 17, 2006
Results First Posted : October 26, 2011
Last Update Posted : April 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Clostridium Infections Diarrhea||Drug: Fidaxomicin Drug: Vancomycin Drug: Matching Placebo to Fidaxomicin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||629 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Multi-National, Multi-Center, Double-Blind, Randomized, Parallel Group Study to Compare the Safety and Efficacy of 200 mg PAR-101 Taken q12h With 125 mg Vancomycin Taken q6h for Ten Days in Subjects With Clostridium Difficile-Associated Diarrhea|
|Actual Study Start Date :||May 2, 2006|
|Actual Primary Completion Date :||July 23, 2008|
|Actual Study Completion Date :||August 21, 2008|
Participants receiving fidaxomicin 200 mg capsules orally two times daily (every 12 hours [q12h] regimen) with intermittent matching placebo to fidaxomicin
200 mg oral capsules two times daily (q12h regimen)
Drug: Matching Placebo to Fidaxomicin
Matching Placebo to Fidaxomicin administered two times daily (intermittently with fidaxomicin dosing)
Active Comparator: Vancomycin
Participants receiving vancomycin 125 mg capsules orally four times daily (every 6 hours [q6h] regimen).
125 mg capsules q6hr (4 times a day)
- Cure Rate at End of Therapy [ Time Frame: Study day 10 (+/- 2 days) ]Percentage of participants with 3 or fewer unformed stools for 2 consecutive days and maintained through the end of therapy, and the subject no longer needed specific anti-Clostridium antibacterial treatment after completion of the course of study medication.
- Recurrence [ Time Frame: Study days 11-40 ]Percentage of participants with the re-establishment of diarrhea to an extent(based on frequency of passed unformed stools) that was greater than that noted on the last day of study medication, and the demonstration of either toxin A or B or both of C. difficile, and retreatment with CDI anti-infective therapy was needed.
- Global Cure [ Time Frame: End of Study (Day 40) ]Percentage of participants who were cured (3 or fewer unformed stools for 2 days through the end of therapy, and no C. difficile therapy after study drug completion) and didn't have recurrence (re-establishment of diarrhea that was greater than on the last day of study drug, positive C. difficile toxin and retreatment with C. difficile therapy) up to Day 40.
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): NCT00314951
|Study Director:||Medical Director||Merck Sharp & Dohme Corp.|