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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00314951
Recruitment Status : Completed
First Posted : April 17, 2006
Results First Posted : October 26, 2011
Last Update Posted : April 21, 2017
Information provided by (Responsible Party):
Optimer Pharmaceuticals LLC

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

Condition or disease Intervention/treatment Phase
Clostridium Infections Diarrhea Drug: Fidaxomicin Drug: Vancomycin Drug: Matching Placebo to Fidaxomicin Phase 3

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 629 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arm Intervention/treatment
Experimental: fidaxomicin
Participants receiving fidaxomicin 200 mg capsules orally two times daily (every 12 hours [q12h] regimen) with intermittent matching placebo to fidaxomicin
Drug: Fidaxomicin
200 mg oral capsules two times daily (q12h regimen)
Other Names:
  • PAR-101
  • OPT-80
  • Dificid®

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).
Drug: Vancomycin
125 mg capsules q6hr (4 times a day)

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Other Outcome Measures:
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00314951

Sponsors and Collaborators
Optimer Pharmaceuticals LLC
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Study Director: Medical Director Merck Sharp & Dohme LLC
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: Optimer Pharmaceuticals LLC Identifier: NCT00314951    
Other Study ID Numbers: 5119-018
101.1.C.003 ( Other Identifier: Optimerpharma Study Number )
First Posted: April 17, 2006    Key Record Dates
Results First Posted: October 26, 2011
Last Update Posted: April 21, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Keywords provided by Optimer Pharmaceuticals LLC:
CDAD, Clostridium difficile, diarrhea
Clostridium difficile-Associated Diarrhea
Additional relevant MeSH terms:
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Clostridium Infections
Signs and Symptoms, Digestive
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Anti-Bacterial Agents
Anti-Infective Agents