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

Primary Purpose

Clostridium Infections, Diarrhea

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
PAR-101/OPT-80
Vancomycin
Sponsored by
Optimer Pharmaceuticals LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clostridium Infections focused on measuring CDAD, Clostridium difficile, diarrhea, Clostridium difficile-Associated Diarrhea

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

Vancomycin

PAR-101/OPT-80

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Recurrence
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
Achieving a cure response at end of treatment and not having a recurrence at any time up to the post-study visit.

Full Information

First Posted
May 1, 2007
Last Updated
March 23, 2017
Sponsor
Optimer Pharmaceuticals LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00468728
Brief Title
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

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
October 4, 2006 (Actual)
Primary Completion Date
December 11, 2009 (Actual)
Study Completion Date
December 11, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Optimer Pharmaceuticals LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridium Infections, Diarrhea
Keywords
CDAD, Clostridium difficile, diarrhea, Clostridium difficile-Associated Diarrhea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
535 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Vancomycin
Arm Title
2
Arm Type
Experimental
Arm Description
PAR-101/OPT-80
Intervention Type
Drug
Intervention Name(s)
PAR-101/OPT-80
Intervention Description
capsules
Intervention Type
Drug
Intervention Name(s)
Vancomycin
Intervention Description
Capsules
Primary Outcome Measure Information:
Title
Cure Rate at End of Therapy
Description
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.
Time Frame
Study day 10 (+/- 2 days)
Secondary Outcome Measure Information:
Title
Recurrence
Description
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.
Time Frame
Study days 11-40
Title
Global Cure
Description
Achieving a cure response at end of treatment and not having a recurrence at any time up to the post-study visit.
Time Frame
End of Study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Sherwood Gorbach, MD
Organizational Affiliation
Optimer Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
City
Gadsden
State/Province
Alabama
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United States
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Phoenix
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Arizona
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United States
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Hot Springs
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Arkansas
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United States
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La Mesa
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California
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United States
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Modesto
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California
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United States
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Palm Springs
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California
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United States
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Rancho Mirage
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California
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United States
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San Jose
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California
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United States
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Santa Ana
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California
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United States
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Vallejo
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California
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United States
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Washington
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District of Columbia
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United States
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Miami
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Florida
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United States
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Port Orange
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Florida
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United States
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Sarasota
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Florida
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United States
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Marietta
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Georgia
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Savannah
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Georgia
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Idaho Falls
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Idaho
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Chicago
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Illinois
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Maywood
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Illinois
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Indianapolis
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Indiana
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Bowling Green
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Kentucky
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Jena
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New Orleans
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Baltimore
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Boston
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West Roxbury
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Detroit
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Keego Harbor
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Royal Oak
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Minneapolis
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Tupelo
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Columbia
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Butte
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Cedar Knolls
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Neptune
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Bronx
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Charlotte
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Winston-Salem
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Fargo
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Akron
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Amherst
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Cleveland
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Columbus
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Dayton
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Ohio
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Philadelphia
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Pittsburgh
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Charleston
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South Carolina
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Rapid City
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South Dakota
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Sioux Falls
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South Dakota
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San Antonio
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Texas
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United States
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Winchester
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Virginia
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United States
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Seattle
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Charlestown
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West Virginia
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Aalst
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Belgium
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Alast
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Belgium
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Antwerp
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Belgium
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Brussels
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Belgium
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Columbia
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Belgium
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Gent
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Belgium
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Kortrijk
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Belgium
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Liege
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Belgium
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Mons
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Belgium
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Montigny-le-Tilleul
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Belgium
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Wilrijk
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Belgium
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Calgary
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Alberta
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Canada
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Edmonton
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Alberta
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Canada
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Hamilton
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Ontario
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Canada
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Toronto
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Ontario
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Canada
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Chicoutimi
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Quebec
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Canada
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Montreal
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Canada
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Sherbrooke
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Quebec
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Canada
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St. Jerome
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Quebec
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Canada
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Trois-Rivieres
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Quebec
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Canada
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Amiens
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France
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Caen Cedex
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France
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Clichy
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France
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Garches
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France
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Grenoble
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France
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Lille
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France
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Tourcoing
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France
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Tours Cedex
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France
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Valenciennes
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France
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Duesseldorf
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Germany
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Frankfurt
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Germany
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Hannover
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Germany
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Hofheim am Taunus
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Germany
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Koln
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Germany
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Lubeck
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Germany
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Luebeck
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Germany
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Magdeburg
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Germany
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Regensburg
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Germany
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Busto Arsizio
Country
Italy
City
Genova
Country
Italy
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Milan
Country
Italy
City
Modena
Country
Italy
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Torino
Country
Italy
City
Badalona
Country
Spain
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Barcelona
Country
Spain
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Madrid
Country
Spain
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Palma de Mallorca
Country
Spain
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Seville
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Spain
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Eskilstuna
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Sweden
City
Goteborg
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Sweden
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Orebro
Country
Sweden
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Great Yarmouth
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Norfolk
Country
United Kingdom
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Derriford
State/Province
Plymouth
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United Kingdom
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Barnsley
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United Kingdom
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Brighton
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United Kingdom
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Cambridge
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United Kingdom
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Edinburgh
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United Kingdom
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Liege
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United Kingdom
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London
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United Kingdom
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Nottingham
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United Kingdom
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Oxford
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United Kingdom
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Oxon
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United Kingdom
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Surrey
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United Kingdom
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York
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United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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
Citations:
PubMed Identifier
22321770
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.
Results Reference
result
PubMed Identifier
24599770
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.
Results Reference
derived
PubMed Identifier
23715579
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.
Results Reference
derived
PubMed Identifier
22752865
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.
Results Reference
derived
PubMed Identifier
22752857
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.
Results Reference
derived

Learn more about this trial

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

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