PAR-101/OPT-80 Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)
NCT ID: NCT00468728
Last Updated: 2017-04-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
535 participants
INTERVENTIONAL
2006-10-04
2009-12-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Vancomycin
Vancomycin
Capsules
2
PAR-101/OPT-80
PAR-101/OPT-80
capsules
Interventions
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PAR-101/OPT-80
capsules
Vancomycin
Capsules
Eligibility Criteria
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Inclusion Criteria
* Females must use adequate contraception
* Signed informed consent
Exclusion Criteria
* Toxic megacolon
* Pregnant
* Concurrent use of diarrheal agents
* Participation in other trials
16 Years
ALL
No
Sponsors
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Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
INDUSTRY
Responsible Party
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Principal Investigators
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Dr. Sherwood Gorbach, MD
Role: STUDY_DIRECTOR
Optimer Pharmaceuticals, Inc.
Locations
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Gadsden, Alabama, United States
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 D.C., 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 City, New Jersey, United States
The Bronx, New York, United States
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
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
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
Charleston, West Virginia, United States
Aalst, , Belgium
Alast, , Belgium
Antwerp, , Belgium
Brussels, , Belgium
Columbia, , Belgium
Ghent, , Belgium
Kortrijk, , Belgium
Liège, , Belgium
Mons, , Belgium
Montigny-le-Tilleul, , Belgium
Wilrijk, , Belgium
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Hamilton, Ontario, Canada
Toronto, Ontario, Canada
Chicoutimi, Quebec, Canada
Montreal, Quebec, Canada
Saint-Jérôme, Quebec, Canada
Sherbrooke, Quebec, Canada
Trois-Rivières, Quebec, Canada
Amiens, , France
Caen, , France
Clichy, , France
Garches, , France
Grenoble, , France
Lille, , France
Tourcoing, , France
Tours, , France
Valenciennes, , France
Cologne, , Germany
Düsseldorf, , Germany
Frankfurt, , Germany
Hanover, , Germany
Hofheim am Taunus, , Germany
Lübeck, , 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
Gothenburg, , Sweden
Örebro, , Sweden
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
Countries
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References
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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.
D'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.
Cornely 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.
Cornely 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.
Figueroa 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.
Other Identifiers
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101.1.C.004
Identifier Type: OTHER
Identifier Source: secondary_id
5119-019
Identifier Type: -
Identifier Source: org_study_id
NCT00427869
Identifier Type: -
Identifier Source: nct_alias
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