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Fidaxomicin Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD) (MK-5119-018)

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.
ClinicalTrials.gov Identifier: NCT00314951
Recruitment Status : Completed
First Posted : April 17, 2006
Results First Posted : October 26, 2011
Last Update Posted : April 21, 2017
Information provided by (Responsible Party):
Optimer Pharmaceuticals LLC

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions: Clostridium Infections
Interventions: Drug: Fidaxomicin
Drug: Vancomycin
Drug: Matching Placebo to Fidaxomicin

  Participant Flow

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
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] 
[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

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
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 
Overall Participants Analyzed 
[Units: Participants]
 307   289   596 
[Units: Years]
Mean (Standard Deviation)
 62.9  (16.9)   60.3  (16.9)   61.6  (16.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      169  55.0%      164  56.7%      333  55.9% 
Male      138  45.0%      125  43.3%      263  44.1% 
Region of Enrollment 
[Units: Participants]
United States   186   165   351 
Canada   121   124   245 

  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

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
No text entered.

  More Information

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: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Optimer Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT00314951     History of Changes
Other Study ID Numbers: 5119-018
101.1.C.003 ( Other Identifier: Optimerpharma Study Number )
First Submitted: April 13, 2006
First Posted: April 17, 2006
Results First Submitted: July 1, 2011
Results First Posted: October 26, 2011
Last Update Posted: April 21, 2017