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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Optimer Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00314951
First received: April 13, 2006
Last updated: September 16, 2011
Last verified: September 2011

April 13, 2006
September 16, 2011
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
Not Provided
Not Provided
 
Fidaxomicin Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)
Not Provided

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 capsules q12hr (2 times a day)
    Other Names:
    • PAR-101
    • OPT-80
    • Dificid
  • Drug: Vancomycin
    125 mg capsules q6hr (4 times a day)
  • Active Comparator: vancomycin
    Intervention: Drug: Vancomycin
  • Experimental: fidaxomicin
    Intervention: Drug: fidaxomicin

*   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
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00314951
101.1.C.003, 101.1.C.003
Yes
Optimer Pharmaceuticals
Optimer Pharmaceuticals
Not Provided
Study Director: Dr. Sherwood Gorbach, MD Optimer Pharmaceuticals, Inc.
Optimer Pharmaceuticals
September 2011

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