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Safety and Efficacy of Fidaxomicin Versus Placebo for Prophylaxis Against Clostridium Difficile-Associated Diarrhea in Adults Undergoing Hematopoietic Stem Cell Transplantation (MK-5119-001) (DEFLECT-1)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01691248
First Posted: September 24, 2012
Last Update Posted: May 1, 2017
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.
Information provided by (Responsible Party):
Optimer Pharmaceuticals LLC
Results First Submitted: March 11, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition: Clostridium Difficile-Associated Diarrhea (CDAD)
Interventions: Drug: fidaxomicin
Drug: Placebo

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Fidaxomicin 200 mg Fidaxomicin tablet once daily for no longer than 40 days
Placebo Placebo tablet once daily for no longer than 40 days

Participant Flow:   Overall Study
    Fidaxomicin   Placebo
STARTED   305 [1]   306 [1] 
Treated   301 [2]   299 [2] 
Safety Analysis Set   300 [3]   300 [3] 
COMPLETED   194   192 
NOT COMPLETED   111   114 
Protocol Violation                43                27 
Adverse Event                24                22 
Withdrawal by Subject                20                18 
Confirmed CDAD                14                31 
Lost to Follow-up                2                5 
Reason not provided                4                4 
Not Treated                4                7 
[1] Randomized
[2] Received at least 1 dose of study drug
[3] A participant randomized to Fidaxomicin, received placebo instead.



  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.
Modified Intent-to-Treat (mITT) consisting of all randomized participants undergoing hematopoietic stem cell transplantation (HSCT) who received at least 1 dose of study drug.

Reporting Groups
  Description
Fidaxomicin 200 mg Fidaxomicin tablet once daily for no longer than 40 days
Placebo Placebo tablet once daily for no longer than 40 days
Total Total of all reporting groups

Baseline Measures
   Fidaxomicin   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 301   299   600 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.1  (12.00)   55.1  (13.23)   55.1  (12.62) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      125  41.5%      103  34.4%      228  38.0% 
Male      176  58.5%      196  65.6%      372  62.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With Occurrence of CDAD From Start of Study Treatment up to 30 Days Post-treatment Follow-up.   [ Time Frame: Up to 30 days post-treatment ]

2.  Secondary:   Percentage of Participants With Occurrence of CDAD From Start of Study Treatment up to 60 Days Post-treatment.   [ Time Frame: Up to 60 days post-treatment ]

3.  Secondary:   Percentage of Participants With Occurrence of CDAD From Start of Study Treatment up to Day 70 of Study.   [ Time Frame: Up to Day 70 of study ]


  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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


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



Responsible Party: Optimer Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT01691248     History of Changes
Other Study ID Numbers: 5119-001
OPT-80-302 ( Other Identifier: Optimerpharma Study Number )
First Submitted: September 19, 2012
First Posted: September 24, 2012
Results First Submitted: March 11, 2016
Results First Posted: April 12, 2016
Last Update Posted: May 1, 2017