PAR-101/OPT-80 Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)

This study has been completed.
Sponsor:
Information provided by:
Optimer Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00468728
First received: May 1, 2007
Last updated: August 8, 2011
Last verified: August 2011
  Purpose

This is a comparative study to investigate the safety and efficacy of PAR-101/OPT-80 (fidaxomicin) versus vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD).


Condition Intervention Phase
Clostridium Infections
Diarrhea
Drug: PAR-101/OPT-80
Drug: Vancomycin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind Study to Compare the Safety and Efficacy of PAR-101 to Vancomycin in Subjects With Clostridium Difficile-Associated Diarrhea (CDAD)

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 subjects 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 subjects 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.

  • Global Cure [ Time Frame: End of Study ] [ Designated as safety issue: No ]
    Achieving a cure response at end of treatment and not having a recurrence at any time up to the post-study visit.


Enrollment: 535
Study Start Date: April 2007
Study Completion Date: December 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Vancomycin
Drug: Vancomycin
Capsules
Experimental: 2
PAR-101/OPT-80
Drug: PAR-101/OPT-80
capsules

Detailed Description:

The primary objective of this pivotal study is to investigate the safety and efficacy of PAR-101/OPT-80 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: NCT00468728

  Hide Study Locations
Locations
United States, Alabama
Gadsden, Alabama, United States
United States, Arizona
Phoenix, Arizona, United States
United States, Arkansas
Hot Springs, Arkansas, United States
United States, California
La Mesa, California, United States
Modesto, California, United States
Palm Springs, California, United States
Rancho Mirage, California, United States
San Jose, California, United States
Santa Ana, California, United States
Vallejo, California, United States
United States, District of Columbia
Washington, District of Columbia, United States
United States, Florida
Miami, Florida, United States
Port Orange, Florida, United States
Sarasota, Florida, United States
United States, Georgia
Marietta, Georgia, United States
Savannah, Georgia, United States
United States, Idaho
Idaho Falls, Idaho, United States
United States, Illinois
Chicago, Illinois, United States
Maywood, Illinois, United States
United States, Indiana
Indianapolis, Indiana, United States
United States, Kentucky
Bowling Green, Kentucky, United States
United States, Louisiana
Jena, Louisiana, United States
New Orleans, Louisiana, United States
United States, Maryland
Baltimore, Maryland, United States
United States, Massachusetts
Boston, Massachusetts, United States
West Roxbury, Massachusetts, United States
United States, Michigan
Detroit, Michigan, United States
Keego Harbor, Michigan, United States
Royal Oak, Michigan, United States
United States, Minnesota
Minneapolis, Minnesota, United States
United States, Mississippi
Tupelo, Mississippi, United States
United States, Missouri
Columbia, Missouri, United States
United States, Montana
Butte, Montana, United States
United States, New Jersey
Cedar Knolls, New Jersey, United States
Neptune, New Jersey, United States
United States, New York
Bronx, New York, United States
United States, North Carolina
Charlotte, North Carolina, United States
Winston-Salem, North Carolina, United States
United States, North Dakota
Fargo, North Dakota, United States
United States, Ohio
Akron, Ohio, United States
Amherst, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Dayton, Ohio, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
United States, South Carolina
Charleston, South Carolina, United States
United States, South Dakota
Rapid City, South Dakota, United States
Sioux Falls, South Dakota, United States
United States, Texas
San Antonio, Texas, United States
United States, Virginia
Winchester, Virginia, United States
United States, Washington
Seattle, Washington, United States
United States, West Virginia
Charlestown, West Virginia, United States
Belgium
Aalst, Belgium
Alast, Belgium
Antwerp, Belgium
Brussels, Belgium
Columbia, Belgium
Gent, Belgium
Kortrijk, Belgium
Liege, Belgium
Mons, Belgium
Montigny-le-Tilleul, Belgium
Wilrijk, Belgium
Canada, Alberta
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Canada, Ontario
Hamilton, Ontario, Canada
Toronto, Ontario, Canada
Canada, Quebec
Chicoutimi, Quebec, Canada
Montreal, Quebec, Canada
Sherbrooke, Quebec, Canada
St. Jerome, Quebec, Canada
Trois-Rivieres, Quebec, Canada
France
Amiens, France
Caen Cedex, France
Clichy, France
Garches, France
Grenoble, France
Lille, France
Tourcoing, France
Tours Cedex, France
Valenciennes, France
Germany
Duesseldorf, Germany
Frankfurt, Germany
Hannover, Germany
Hofheim am Taunus, Germany
Koln, Germany
Lubeck, Germany
Luebeck, Germany
Magdeburg, Germany
Regensburg, Germany
Italy
Busto Arsizio, Italy
Genova, Italy
Milan, Italy
Modena, Italy
Torino, Italy
Spain
Badalona, Spain
Barcelona, Spain
Madrid, Spain
Palma de Mallorca, Spain
Seville, Spain
Sweden
Eskilstuna, Sweden
Goteborg, Sweden
Orebro, Sweden
United Kingdom
Great Yarmouth, Norfolk, United Kingdom
Derriford, Plymouth, United Kingdom
Barnsley, United Kingdom
Brighton, United Kingdom
Cambridge, United Kingdom
Edinburgh, United Kingdom
Liege, United Kingdom
London, United Kingdom
Nottingham, United Kingdom
Oxford, United Kingdom
Oxon, United Kingdom
Surrey, United Kingdom
York, United Kingdom
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: Y.K. Shue, Optimer Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00468728     History of Changes
Obsolete Identifiers: NCT00427869
Other Study ID Numbers: 101.1.C.004, 101.1.C.004
Study First Received: May 1, 2007
Results First Received: July 1, 2011
Last Updated: August 8, 2011
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Spain: Ministry of Health and Consumption
Belgium: Federal Agency for Medicinal Products and Health Products
Italy: The Italian Medicines Agency
Sweden: Medical Products Agency
Germany: BfArM

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

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

ClinicalTrials.gov processed this record on September 18, 2014