PAR-101/OPT-80 Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)
A Double-Blind Study to Compare the Safety and Efficacy of PAR-101 to Vancomycin in Subjects With Clostridium Difficile-Associated Diarrhea (CDAD)
2 other identifiers
interventional
535
9 countries
116
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2006
Typical duration for phase_3
116 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 4, 2006
CompletedFirst Submitted
Initial submission to the registry
May 1, 2007
CompletedFirst Posted
Study publicly available on registry
May 3, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 11, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 11, 2009
CompletedResults Posted
Study results publicly available
July 29, 2011
CompletedApril 21, 2017
March 1, 2017
3.2 years
May 1, 2007
July 1, 2011
March 23, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cure Rate at End of Therapy
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.
Study day 10 (+/- 2 days)
Secondary Outcomes (2)
Recurrence
Study days 11-40
Global Cure
End of Study
Study Arms (2)
1
ACTIVE COMPARATORVancomycin
2
EXPERIMENTALPAR-101/OPT-80
Interventions
Eligibility Criteria
You may qualify if:
- Males/females with CDAD
- Females must use adequate contraception
- Signed informed consent
You may not qualify if:
- Life-threatening CDAD
- Toxic megacolon
- Pregnant
- Concurrent use of diarrheal agents
- Participation in other trials
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (116)
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Gadsden, Alabama, United States
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Phoenix, Arizona, United States
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Hot Springs, Arkansas, United States
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La Mesa, California, United States
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Modesto, California, United States
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Palm Springs, California, United States
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Rancho Mirage, California, United States
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San Jose, California, United States
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Santa Ana, California, United States
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Vallejo, California, United States
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Washington D.C., District of Columbia, United States
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Miami, Florida, United States
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Port Orange, Florida, United States
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Sarasota, Florida, United States
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Marietta, Georgia, United States
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Savannah, Georgia, United States
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Idaho Falls, Idaho, United States
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Chicago, Illinois, United States
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Maywood, Illinois, United States
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Indianapolis, Indiana, United States
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Bowling Green, Kentucky, United States
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Jena, Louisiana, United States
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New Orleans, Louisiana, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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West Roxbury, Massachusetts, United States
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Detroit, Michigan, United States
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Keego Harbor, Michigan, United States
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Royal Oak, Michigan, United States
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Minneapolis, Minnesota, United States
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Tupelo, Mississippi, United States
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Columbia, Missouri, United States
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Butte, Montana, United States
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Cedar Knolls, New Jersey, United States
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Neptune City, New Jersey, United States
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The Bronx, New York, United States
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Charlotte, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Fargo, North Dakota, United States
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Akron, Ohio, United States
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Amherst, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Dayton, Ohio, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Charleston, South Carolina, United States
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Rapid City, South Dakota, United States
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Sioux Falls, South Dakota, United States
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San Antonio, Texas, United States
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Winchester, Virginia, United States
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Seattle, Washington, United States
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Charleston, West Virginia, United States
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Aalst, Belgium
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Alast, Belgium
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Antwerp, Belgium
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Brussels, Belgium
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Columbia, Belgium
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Ghent, Belgium
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Kortrijk, Belgium
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Liège, Belgium
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Mons, Belgium
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Montigny-le-Tilleul, Belgium
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Wilrijk, Belgium
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Hamilton, Ontario, Canada
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Toronto, Ontario, Canada
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Chicoutimi, Quebec, Canada
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Montreal, Quebec, Canada
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Saint-Jérôme, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Trois-Rivières, Quebec, Canada
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Amiens, France
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Caen, France
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Clichy, France
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Garches, France
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Grenoble, France
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Lille, France
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Tourcoing, France
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Tours, France
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Valenciennes, France
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Cologne, Germany
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Düsseldorf, Germany
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Frankfurt, Germany
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Hanover, Germany
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Hofheim am Taunus, Germany
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Lübeck, Germany
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Magdeburg, Germany
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Regensburg, Germany
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Busto Arsizio, Italy
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Genova, Italy
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Milan, Italy
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Modena, Italy
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Torino, Italy
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Badalona, Spain
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Barcelona, Spain
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Madrid, Spain
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Palma de Mallorca, Spain
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Seville, Spain
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Eskilstuna, Sweden
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Gothenburg, Sweden
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Örebro, Sweden
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Great Yarmouth, Norfolk, United Kingdom
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Derriford, Plymouth, United Kingdom
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Barnsley, United Kingdom
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Brighton, United Kingdom
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Cambridge, United Kingdom
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Edinburgh, United Kingdom
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Liege, United Kingdom
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London, United Kingdom
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Nottingham, United Kingdom
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Oxford, United Kingdom
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Oxon, United Kingdom
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Surrey, United Kingdom
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York, United Kingdom
Related Publications (5)
Cornely OA, Crook DW, Esposito R, Poirier A, Somero MS, Weiss K, Sears P, Gorbach S; OPT-80-004 Clinical Study Group. Fidaxomicin versus vancomycin for infection with Clostridium difficile in Europe, Canada, and the USA: a double-blind, non-inferiority, randomised controlled trial. Lancet Infect Dis. 2012 Apr;12(4):281-9. doi: 10.1016/S1473-3099(11)70374-7. Epub 2012 Feb 8.
PMID: 22321770RESULTD'Agostino RB Sr, Collins SH, Pencina KM, Kean Y, Gorbach S. Risk estimation for recurrent Clostridium difficile infection based on clinical factors. Clin Infect Dis. 2014 May;58(10):1386-93. doi: 10.1093/cid/ciu107. Epub 2014 Mar 5.
PMID: 24599770DERIVEDCornely OA, Miller MA, Fantin B, Mullane K, Kean Y, Gorbach S. Resolution of Clostridium difficile-associated diarrhea in patients with cancer treated with fidaxomicin or vancomycin. J Clin Oncol. 2013 Jul 1;31(19):2493-9. doi: 10.1200/JCO.2012.45.5899. Epub 2013 May 28.
PMID: 23715579DERIVEDCornely OA, Miller MA, Louie TJ, Crook DW, Gorbach SL. Treatment of first recurrence of Clostridium difficile infection: fidaxomicin versus vancomycin. Clin Infect Dis. 2012 Aug;55 Suppl 2(Suppl 2):S154-61. doi: 10.1093/cid/cis462.
PMID: 22752865DERIVEDFigueroa I, Johnson S, Sambol SP, Goldstein EJ, Citron DM, Gerding DN. Relapse versus reinfection: recurrent Clostridium difficile infection following treatment with fidaxomicin or vancomycin. Clin Infect Dis. 2012 Aug;55 Suppl 2(Suppl 2):S104-9. doi: 10.1093/cid/cis357.
PMID: 22752857DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Scientific Officer
- Organization
- Optimer Pharmaceuticals, Inc.
Study Officials
- STUDY DIRECTOR
Dr. Sherwood Gorbach, MD
Optimer Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 1, 2007
First Posted
May 3, 2007
Study Start
October 4, 2006
Primary Completion
December 11, 2009
Study Completion
December 11, 2009
Last Updated
April 21, 2017
Results First Posted
July 29, 2011
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will share
http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php