Post-marketing Surveillance Study of Invasive Mycosis With Posaconazole (Study P04641)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00726609
First received: July 30, 2008
Last updated: July 15, 2014
Last verified: July 2014
Results First Received: August 13, 2009  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Mycoses
Intervention: Drug: Posaconazole

  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
Posaconazole (Assigned by Physician in Normal Practice)
  • Treatment of invasive fungal infection.
  • Prophylaxis of invasive fungal infection.

Participant Flow:   Overall Study
    Posaconazole (Assigned by Physician in Normal Practice)  
STARTED     214  
COMPLETED     116 [1]
NOT COMPLETED     98  
Adverse Event                 10  
Withdrawal by Subject                 2  
Lack of Efficacy                 25  
Not specified                 16  
Missing                 42  
Unknown                 3  
[1] For 26 participants in the Missing category, it is unknown if they completed the study.



  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.
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Reporting Groups
  Description
Posaconazole (Assigned by Physician in Normal Practice)
  • Treatment of invasive fungal infection.
  • Prophylaxis of invasive fungal infection.

Baseline Measures
    Posaconazole (Assigned by Physician in Normal Practice)  
Number of Participants  
[units: participants]
  214  
Age  
[units: years]
Mean ± Standard Deviation
  55.6  ± 12.77  
Gender  
[units: participants]
 
Female     79  
Male     135  
Region of Enrollment  
[units: participants]
 
Germany     214  



  Outcome Measures

1.  Primary:   Number of Participants Reporting Adverse Drug Reactions.   [ Time Frame: Before starting treatment with posaconazole, during treatment, and until 100 days after treatment. ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp.
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00726609     History of Changes
Other Study ID Numbers: P04641
Study First Received: July 30, 2008
Results First Received: August 13, 2009
Last Updated: July 15, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices