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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00468728
Recruitment Status : Completed
First Posted : May 3, 2007
Results First Posted : July 29, 2011
Last Update Posted : April 21, 2017
Information provided by (Responsible Party):
Optimer Pharmaceuticals LLC

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).

Condition or disease Intervention/treatment Phase
Clostridium Infections Diarrhea Drug: PAR-101/OPT-80 Drug: Vancomycin Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 535 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : October 4, 2006
Actual Primary Completion Date : December 11, 2009
Actual Study Completion Date : December 11, 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arm Intervention/treatment
Active Comparator: 1
Drug: Vancomycin

Experimental: 2
Drug: PAR-101/OPT-80

Primary Outcome Measures :
  1. Cure Rate at End of Therapy [ Time Frame: Study day 10 (+/- 2 days) ]
    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 :
  1. Recurrence [ Time Frame: Study days 11-40 ]
    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.

  2. Global Cure [ Time Frame: End of Study ]
    Achieving a cure response at end of treatment and not having a recurrence at any time up to the post-study visit.

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00468728

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United States, Alabama
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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Liege, United Kingdom
London, United Kingdom
Nottingham, United Kingdom
Oxford, United Kingdom
Oxon, United Kingdom
Surrey, United Kingdom
York, United Kingdom
Sponsors and Collaborators
Optimer Pharmaceuticals LLC
Study Director: Dr. Sherwood Gorbach, MD Optimer Pharmaceuticals, Inc.

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Optimer Pharmaceuticals LLC Identifier: NCT00468728     History of Changes
Obsolete Identifiers: NCT00427869
Other Study ID Numbers: 5119-019
101.1.C.004 ( Other Identifier: Optimerpharma Study Number )
First Posted: May 3, 2007    Key Record Dates
Results First Posted: July 29, 2011
Last Update Posted: April 21, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Keywords provided by Optimer Pharmaceuticals LLC:
CDAD, Clostridium difficile, diarrhea
Clostridium difficile-Associated Diarrhea

Additional relevant MeSH terms:
Clostridium Infections
Signs and Symptoms, Digestive
Signs and Symptoms
Gram-Positive Bacterial Infections
Bacterial Infections
Anti-Bacterial Agents
Anti-Infective Agents