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Safety and Efficacy Study of Posaconazole vs. Fluconazole for Prevention of Invasive Fungal Infection (P05387 AM1)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00811928
First received: December 18, 2008
Last updated: September 16, 2011
Last verified: September 2011
History of Changes
Results First Received: May 26, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Leukopenia
Interventions: Drug: Posaconazole
Drug: Fluconazole

  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 Posaconazole oral suspension (40 mg/ml), 200 mg (5mL) three times a day (TID) with meals
Fluconazole Fluconazole 400 mg daily (QD), given as 2 capsules of 50 mg and 2 capsules of 150 mg (a total of 4 capsules) with or without food

Participant Flow:   Overall Study
    Posaconazole     Fluconazole  
STARTED     129     123  
COMPLETED     90     90  
NOT COMPLETED     39     33  
AEs and SAEs Including Death                 7                 11  
Withdrawal by Subject                 18                 12  
Did Not Take Study Drug                 3                 0  
Without Primary Efficacy Endpoint Data                 7                 4  
Investigator Decision                 2                 1  
Poor Compliance                 2                 5  



  Baseline Characteristics
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Reporting Groups
  Description
Posaconazole Posaconazole oral suspension (40 mg/ml), 200 mg (5mL) three times a day (TID) with meals
Fluconazole Fluconazole 400 mg daily (QD), given as 2 capsules of 50 mg and 2 capsules of 150 mg (a total of 4 capsules) with or without food
Total Total of all reporting groups

Baseline Measures
    Posaconazole     Fluconazole     Total  
Number of Participants  
[units: participants]
 		  117     117     234  
Age [1]
[units: participants]
Mean ± Standard Deviation 		  39.3  ± 13.01     40.6  ± 12.50     40.4  ± 12.73  
Gender [1]
[units: participants]
 		     
Female     62     65     127  
Male     55     52     107  
[1] The full analysis set (FAS) included all of those randomized participants who received at least one dose of study drug, and had at least one post-treatment follow-up data of primary efficacy variable.



  Outcome Measures
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1.  Primary:   Number of Participants With Proven or Probable Diagnosis of Invasive Fungal Infection (IFI) During the Treatment Period   [ Time Frame: Up to 12 Weeks (84 days) plus 7 days ]
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2.  Secondary:   Number of Participants With Proven or Probable Diagnosis of IFI Within 100 Days From Randomization   [ Time Frame: From randomization date to Day 100 ]
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3.  Secondary:   Time From Randomization to the First Onset of Proven or Probable IFI   [ Time Frame: From randomization date to Day 100 ]
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4.  Secondary:   Time From Randomization to Administration of First Systemic Antifungal Intravenous (IV) Therapy   [ Time Frame: Up to 12 weeks (84 days) ]
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5.  Secondary:   Number of Participants With Clinical Failure During Treatment   [ Time Frame: Up to 12 weeks (84 days) ]
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6.  Secondary:   Number of Participants in Whom All-cause Mortality Occurred Within 100 Days From Randomization   [ Time Frame: Randomization date to Day 100 ]
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7.  Secondary:   Number of Participants in Whom Mortality is Unlikely, Possibly, and Probably Related to Fungal Infection Occurred Within 100 Days From Randomization   [ Time Frame: From randomization date to Day 100 ]
  Show Outcome Measure 7


  Serious Adverse Events
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  Other Adverse Events
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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.


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
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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: Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00811928     History of Changes
Other Study ID Numbers: P05387
Study First Received: December 18, 2008
Results First Received: May 26, 2011
Last Updated: September 16, 2011
Health Authority: China: Food and Drug Administration