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
  Purpose

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


Condition Intervention Phase
Clostridium Infections
Diarrhea
Drug: fidaxomicin
Drug: Vancomycin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Optimer Pharmaceuticals:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 629
Study Start Date: May 2006
Study Completion Date: August 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: vancomycin Drug: Vancomycin
125 mg capsules q6hr (4 times a day)
Experimental: fidaxomicin Drug: fidaxomicin
200 mg capsules q12hr (2 times a day)
Other Names:
  • PAR-101
  • OPT-80
  • Dificid

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00314951

  Hide Study Locations
Locations
United States, Alabama
Dothan, Alabama, United States
United States, Arkansas
Hot Springs, Arkansas, United States
United States, California
Long Beach, California, United States
San Diego, California, United States
United States, Connecticut
Stamford, Connecticut, United States
United States, Delaware
Newark, Delaware, United States
United States, Florida
Clearwater, Florida, United States
Gainesville, Florida, United States
Smyrna Beach, Florida, United States
United States, Georgia
Decatur, Georgia, United States
Marietta, Georgia, United States
United States, Idaho
Idaho Falls, Idaho, United States
United States, Illinois
Chicago, Illinois, United States
United States, Indiana
South Bend, Indiana, United States
United States, Louisiana
Jena, Louisiana, United States
United States, Maryland
Baltimore, Maryland, United States
United States, Massachusetts
Boston, Massachusetts, United States
Springfield, Massachusetts, United States
United States, Michigan
Detroit, Michigan, United States
Keego Harbor, Michigan, United States
United States, Minnesota
Minneapolis, Minnesota, United States
Rochester, Minnesota, United States
United States, Missouri
St. Louis, Missouri, United States
United States, Montana
Butte, Montana, United States
United States, New Jersey
Camden, New Jersey, United States
Neptune, New Jersey, United States
Newark, New Jersey, United States
United States, New York
Albany, New York, United States
Buffalo, New York, United States
New York, New York, United States
United States, North Carolina
Charlotte, North Carolina, United States
Winston-Salem, North Carolina, United States
United States, Ohio
Akron, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Toledo, Ohio, United States
United States, Oregon
Portland, Oregon, United States
United States, Pennsylvania
Allentown, Pennsylvania, United States
United States, Tennessee
Johnson City, Tennessee, United States
United States, Texas
Fort Worth, Texas, United States
Houston, Texas, United States
United States, Virginia
Charlottesville, Virginia, United States
United States, Wisconsin
Madison, Wisconsin, United States
Canada, Alberta
Calgary, Alberta, Canada
Canada, British Columbia
New Westminster, British Columbia, Canada
Surrey, British Columbia, Canada
Canada, Ontario
Ajax, Ontario, Canada
Hamilton, Ontario, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Windsor, Ontario, Canada
Canada, Quebec
Chicoutimi, Quebec, Canada
Levis, Quebec, Canada
Montreal, Quebec, Canada
Quebec City, Quebec, Canada
Sherbrooke, Quebec, Canada
Canada, Saskatchewan
Saskatoon, Saskatchewan, Canada
Canada
Quebec, Canada
Sponsors and Collaborators
Optimer Pharmaceuticals
Investigators
Study Director: Dr. Sherwood Gorbach, MD Optimer Pharmaceuticals, Inc.
  More Information

No publications provided by Optimer Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Optimer Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00314951     History of Changes
Other Study ID Numbers: 101.1.C.003, 101.1.C.003
Study First Received: April 13, 2006
Results First Received: July 1, 2011
Last Updated: September 16, 2011
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Optimer Pharmaceuticals:
CDAD, Clostridium difficile, diarrhea
Clostridium difficile-Associated Diarrhea

Additional relevant MeSH terms:
Clostridium Infections
Diarrhea
Gram-Positive Bacterial Infections
Bacterial Infections
Signs and Symptoms, Digestive
Signs and Symptoms
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014