Clinical trial NCT00468728: PAR-101/OPT-80 Versus Vancomycin for the Treatment of 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Clostridium Infections
Diarrhea
Keywords: CDAD, Clostridium difficile, diarrhea
Clostridium difficile-Associated Diarrhea
Lead sponsor: Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Sponsor class: INDUSTRY
First posted: 2007-05-03
Enrollment: 535
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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 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

Primary outcomes:
measure: Cure Rate at End of Therapy
timeFrame: Study day 10 (+/- 2 days)
Secondary outcomes:
measure: Recurrence
timeFrame: Study days 11-40
measure: Global Cure
timeFrame: End of Study
Other outcomes:
Locations:
city: Gadsden
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Hot Springs
country: United States
state: Arkansas
city: La Mesa
country: United States
state: California
city: Modesto
country: United States
state: California
city: Palm Springs
country: United States
state: California
city: Rancho Mirage
country: United States
state: California
city: San Jose
country: United States
state: California
city: Santa Ana
country: United States
state: California
city: Vallejo
country: United States
state: California
city: Washington
country: United States
state: District of Columbia
city: Miami
country: United States
state: Florida
city: Port Orange
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: Marietta
country: United States
state: Georgia
city: Savannah
country: United States
state: Georgia
city: Idaho Falls
country: United States
state: Idaho
city: Chicago
country: United States
state: Illinois
city: Maywood
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Bowling Green
country: United States
state: Kentucky
city: Jena
country: United States
state: Louisiana
city: New Orleans
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: West Roxbury
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: Keego Harbor
country: United States
state: Michigan
city: Royal Oak
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: Tupelo
country: United States
state: Mississippi
city: Columbia
country: United States
state: Missouri
city: Butte
country: United States
state: Montana
city: Cedar Knolls
country: United States
state: New Jersey
city: Neptune
country: United States
state: New Jersey
city: Bronx
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Fargo
country: United States
state: North Dakota
city: Akron
country: United States
state: Ohio
city: Amherst
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Dayton
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Rapid City
country: United States
state: South Dakota
city: Sioux Falls
country: United States
state: South Dakota
city: San Antonio
country: United States
state: Texas
city: Winchester
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Charlestown
country: United States
state: West Virginia
city: Aalst
country: Belgium
city: Alast
country: Belgium
city: Antwerp
country: Belgium
city: Brussels
country: Belgium
city: Columbia
country: Belgium
city: Gent
country: Belgium
city: Kortrijk
country: Belgium
city: Liege
country: Belgium
city: Mons
country: Belgium
city: Montigny-le-Tilleul
country: Belgium
city: Wilrijk
country: Belgium
city: Calgary
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: Hamilton
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Chicoutimi
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Sherbrooke
country: Canada
state: Quebec
city: St. Jerome
country: Canada
state: Quebec
city: Trois-Rivieres
country: Canada
state: Quebec
city: Amiens
country: France
city: Caen Cedex
country: France
city: Clichy
country: France
city: Garches
country: France
city: Grenoble
country: France
city: Lille
country: France
city: Tourcoing
country: France
city: Tours Cedex
country: France
city: Valenciennes
country: France
city: Duesseldorf
country: Germany
city: Frankfurt
country: Germany
city: Hannover
country: Germany
city: Hofheim am Taunus
country: Germany
city: Koln
country: Germany
city: Lubeck
country: Germany
city: Luebeck
country: Germany
city: Magdeburg
country: Germany
city: Regensburg
country: Germany
city: Busto Arsizio
country: Italy
city: Genova
country: Italy
city: Milan
country: Italy
city: Modena
country: Italy
city: Torino
country: Italy
city: Badalona
country: Spain
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Palma de Mallorca
country: Spain
city: Seville
country: Spain
city: Eskilstuna
country: Sweden
city: Goteborg
country: Sweden
city: Orebro
country: Sweden
city: Great Yarmouth
country: United Kingdom
state: Norfolk
city: Derriford
country: United Kingdom
state: Plymouth
city: Barnsley
country: United Kingdom
city: Brighton
country: United Kingdom
city: Cambridge
country: United Kingdom
city: Edinburgh
country: United Kingdom
city: Liege
country: United Kingdom
city: London
country: United Kingdom
city: Nottingham
country: United Kingdom
city: Oxford
country: United Kingdom
city: Oxon
country: United Kingdom
city: Surrey
country: United Kingdom
city: York
country: United Kingdom
Study officials:
affiliation: Optimer Pharmaceuticals, Inc.
name: Dr. Sherwood Gorbach, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.