Fidaxomicin Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Optimer Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00314951
First received: April 13, 2006
Last updated: September 16, 2011
Last verified: September 2011
Results First Received: July 1, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Clostridium Infections
Diarrhea
Interventions: Drug: fidaxomicin
Drug: Vancomycin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were enrolled from May 2006 to August 2008 by centers in the United States and Canada.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Vancomycin 125 mg administered 4 times daily (q6hr)
Fidaxomicin 200 mg administered twice daily (q12hr)

Participant Flow for 3 periods

Period 1:   Enrollment
    Vancomycin     Fidaxomicin  
STARTED     323     306  
COMPLETED     323 [1]   300 [1]
NOT COMPLETED     0     6  
[1] 6 subjects took incorrect treatment assignment, 6 subjects didn't take drug

Period 2:   Treatment
    Vancomycin     Fidaxomicin  
STARTED     323     300  
COMPLETED     307     289  
NOT COMPLETED     16     11  
Didn't meet criteria for mITT population                 16                 11  

Period 3:   Follow-up
    Vancomycin     Fidaxomicin  
STARTED     307     289  
COMPLETED     263     255  
NOT COMPLETED     44     34  
mITT failure                 44                 34  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Vancomycin 125 mg administered 4 times daily (q6hr)
Fidaxomicin 200 mg administered twice daily (q12hr)
Total Total of all reporting groups

Baseline Measures
    Vancomycin     Fidaxomicin     Total  
Number of Participants  
[units: participants]
  307     289     596  
Age  
[units: years]
Mean ± Standard Deviation
  62.9  ± 16.9     60.3  ± 16.9     61.6  ± 16.9  
Gender  
[units: participants]
     
Female     169     164     333  
Male     138     125     263  
Region of Enrollment  
[units: participants]
     
United States     186     165     351  
Canada     121     124     245  



  Outcome Measures
  Show All Outcome Measures

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

2.  Secondary:   Recurrence   [ Time Frame: Study days 11-40 ]

3.  Other Pre-specified:   Global Cure   [ Time Frame: End of Study (Day 40) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Chief Scientific Officer
Organization: Optimer Pharmaceuticals, Inc.
phone: 1-855-343-4243
e-mail: medinfo@optimerpharma.com


No publications provided by Optimer Pharmaceuticals

Publications automatically indexed to this study:


Responsible Party: Optimer Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00314951     History of Changes
Other Study ID Numbers: 101.1.C.003, 101.1.C.003
Study First Received: April 13, 2006
Results First Received: July 1, 2011
Last Updated: September 16, 2011
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
United Kingdom: Medicines and Healthcare Products Regulatory Agency