Trial record 1 of 1 for:    OPT-80-302
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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:
Information provided by (Responsible Party):
Optimer Pharmaceuticals LLC
ClinicalTrials.gov Identifier:
NCT01691248
First received: September 19, 2012
Last updated: March 11, 2016
Last verified: March 2016
Results First Received: March 11, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, 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
No text entered.

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
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  
Number of Participants  
[units: participants]
  301     299     600  
Age  
[units: Years]
Mean (Standard Deviation)
  55.1  (12.00)     55.1  (13.23)     55.1  (12.62)  
Gender  
[units: Participants]
     
Female     125     103     228  
Male     176     196     372  



  Outcome Measures
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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 )
Study First Received: September 19, 2012
Results First Received: March 11, 2016
Last Updated: March 11, 2016
Health Authority: United States: Food and Drug Administration
Canada: Health Canada