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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Optimer Pharmaceuticals LLC
ClinicalTrials.gov Identifier:
NCT00314951
First received: April 13, 2006
Last updated: June 7, 2016
Last verified: June 2016

April 13, 2006
June 7, 2016
May 2006
July 2008   (final data collection date for primary outcome measure)
Cure Rate at End of Therapy [ Time Frame: Study day 10 (+/- 2 days) ] [ Designated as safety issue: No ]
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.
Cure Rate at End of Therapy
Complete list of historical versions of study NCT00314951 on ClinicalTrials.gov Archive Site
Recurrence [ Time Frame: Study days 11-40 ] [ Designated as safety issue: No ]
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.
Recurrence rate
Global Cure [ Time Frame: End of Study (Day 40) ] [ Designated as safety issue: No ]
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.
Not Provided
 
Fidaxomicin Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD) (MK-5119-018)
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
This is a comparative study to investigate the safety and efficacy of fidaxomicin versus vancomycin in subjects with Clostridium difficile-Associated Diarrhea (CDAD).
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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Clostridium Infections
  • Diarrhea
  • Drug: Fidaxomicin
    200 mg oral capsules two times daily (q12h regimen)
    Other Names:
    • PAR-101
    • OPT-80
    • Dificid®
  • Drug: Vancomycin
    125 mg capsules q6hr (4 times a day)
  • Drug: Matching Placebo to Fidaxomicin
    Matching Placebo to Fidaxomicin administered two times daily (intermittently with fidaxomicin dosing)
  • Experimental: fidaxomicin
    Participants receiving fidaxomicin 200 mg capsules orally two times daily (every 12 hours [q12h] regimen) with intermittent matching placebo to fidaxomicin
    Interventions:
    • Drug: Fidaxomicin
    • Drug: Matching Placebo to Fidaxomicin
  • Active Comparator: Vancomycin
    Participants receiving vancomycin 125 mg capsules orally four times daily (every 6 hours [q6h] regimen).
    Intervention: Drug: Vancomycin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
629
August 2008
July 2008   (final data collection date for primary outcome measure)

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
Both
16 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Canada,   United States
 
NCT00314951
5119-018, 101.1.C.003
Yes
Not Provided
Not Provided
Optimer Pharmaceuticals LLC
Optimer Pharmaceuticals LLC
Not Provided
Study Director: Medical Director Merck Sharp & Dohme Corp.
Optimer Pharmaceuticals LLC
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP