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

Condition(s) targeted: Clostridium Infections; Diarrhea

Intervention: PAR-101/OPT-80 (Drug); Vancomycin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Optimer Pharmaceuticals LLC

Official(s) and/or principal investigator(s):
Dr. Sherwood Gorbach, MD, Study Director, Affiliation: Optimer Pharmaceuticals, Inc.

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).

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)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Cure Rate at End of Therapy

Secondary outcome:

Recurrence

Global Cure

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.

Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.

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

Aalst, Belgium

Alast, Belgium

Antwerp, Belgium

Brussels, Belgium

Columbia, Belgium

Gent, Belgium

Kortrijk, Belgium

Liege, Belgium

Mons, Belgium

Montigny-le-Tilleul, Belgium

Wilrijk, Belgium

Amiens, France

Caen Cedex, France

Clichy, France

Garches, France

Grenoble, France

Lille, France

Tourcoing, France

Tours Cedex, France

Valenciennes, France

Duesseldorf, Germany

Frankfurt, Germany

Hannover, Germany

Hofheim am Taunus, Germany

Koln, Germany

Lubeck, Germany

Luebeck, Germany

Magdeburg, Germany

Regensburg, Germany

Busto Arsizio, Italy

Genova, Italy

Milan, Italy

Modena, Italy

Torino, Italy

Badalona, Spain

Barcelona, Spain

Madrid, Spain

Palma de Mallorca, Spain

Seville, Spain

Eskilstuna, Sweden

Goteborg, Sweden

Orebro, Sweden

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

Gadsden, Alabama, United States

Calgary, Alberta, Canada

Edmonton, Alberta, Canada

Phoenix, Arizona, United States

Hot Springs, Arkansas, United States

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

Washington, District of Columbia, United States

Miami, Florida, United States

Port Orange, Florida, United States

Sarasota, Florida, United States

Marietta, Georgia, United States

Savannah, Georgia, United States

Idaho Falls, Idaho, United States

Chicago, Illinois, United States

Maywood, Illinois, United States

Indianapolis, Indiana, United States

Bowling Green, Kentucky, United States

Jena, Louisiana, United States

New Orleans, Louisiana, United States

Baltimore, Maryland, United States

Boston, Massachusetts, United States

West Roxbury, Massachusetts, United States

Detroit, Michigan, United States

Keego Harbor, Michigan, United States

Royal Oak, Michigan, United States

Minneapolis, Minnesota, United States

Tupelo, Mississippi, United States

Columbia, Missouri, United States

Butte, Montana, United States

Cedar Knolls, New Jersey, United States

Neptune, New Jersey, United States

Bronx, New York, United States

Great Yarmouth, Norfolk, United Kingdom

Charlotte, North Carolina, United States

Winston-Salem, North Carolina, United States

Fargo, North Dakota, United States

Akron, Ohio, United States

Amherst, Ohio, United States

Cleveland, Ohio, United States

Columbus, Ohio, United States

Dayton, Ohio, United States

Hamilton, Ontario, Canada

Toronto, Ontario, Canada

Philadelphia, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States

Derriford, Plymouth, United Kingdom

Chicoutimi, Quebec, Canada

Montreal, Quebec, Canada

Sherbrooke, Quebec, Canada

St. Jerome, Quebec, Canada

Trois-Rivieres, Quebec, Canada

Charleston, South Carolina, United States

Rapid City, South Dakota, United States

Sioux Falls, South Dakota, United States

San Antonio, Texas, United States

Winchester, Virginia, United States

Seattle, Washington, United States

Charlestown, West Virginia, United States

Starting date: April 2007
Last updated: August 8, 2011