Fidaxomicin Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD) (MK-5119-018)

Study Overview
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Brief Summary
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This is a comparative study to investigate the safety and efficacy of fidaxomicin versus vancomycin in subjects with Clostridium difficile-Associated Diarrhea (CDAD).

Detailed Description
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The primary objective of this pivotal study is to investigate the safety and efficacy of fidaxomicin versus vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD). The cure rates at end of therapy and recurrence rates will be evaluated and compared.

Official Title
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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

Conditions
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Clostridium Infections, Diarrhea

Intervention / Treatment
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* Drug: Fidaxomicin
* Drug: Vancomycin
* Drug: Matching Placebo to Fidaxomicin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males/females with CDAD Females must use adequate contraception Signed informed consent Exclusion Criteria: Life-threatening CDAD Toxic megacolon Pregnant Concurrent use of diarrheal agents Participation in other trials

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fidaxomicin<br>Participants receiving fidaxomicin 200 mg capsules orally two times daily (every 12 hours [q12h] regimen) with intermittent matching placebo to fidaxomicin | Drug: Fidaxomicin<br>* 200 mg oral capsules two times daily (q12h regimen)<br>* Other names: Dificid®;Drug: Matching Placebo to Fidaxomicin<br>* Matching Placebo to Fidaxomicin administered two times daily (intermittently with fidaxomicin dosing)<br>|
| Active Comparator: Vancomycin<br>Participants receiving vancomycin 125 mg capsules orally four times daily (every 6 hours [q6h] regimen). | Drug: Vancomycin<br>* 125 mg capsules q6hr (4 times a day)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cure Rate at End of Therapy | 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. | Study day 10 (+/- 2 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence | 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. | Study days 11-40 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CDAD, Clostridium difficile, diarrhea, Clostridium difficile-Associated Diarrhea