Posaconazole Treatment of Invasive Fungal Infection (IFI) (P05551) (COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00811642
First received: December 18, 2008
Last updated: March 31, 2011
Last verified: March 2011
Results First Received: March 31, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
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
No text entered.

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 400 mg twice a day (BID) oral suspension for 12 weeks

Participant Flow:   Overall Study
    Posaconazole  
STARTED     62 [1]
COMPLETED     47 [2]
NOT COMPLETED     15  
Adverse Event                 3  
Protocol Violation                 1  
Death                 2  
Withdrawal by Subject                 7  
Cumulative use of antifungal agent                 2  
[1] 63 participants were screened and enrolled; 62 participants from Safety Set (SS) started study drug.
[2] The Per Protocol Set (PPS) includes the 47 participants who completed the study per protocol.



  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.
No text entered.

Reporting Groups
  Description
Posaconazole 400 mg twice a day (BID) oral suspension for 12 weeks

Baseline Measures
    Posaconazole  
Number of Participants  
[units: participants]
  62  
Age  
[units: years]
Mean ± Standard Deviation
  40.41  ± 14.752  
Gender  
[units: participants]
 
Female     34  
Male     28  
Region of Enrollment  
[units: participants]
 
China     62  



  Outcome Measures
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1.  Primary:   Number of Participants Who Had Clinical Response at 12 Weeks With Posaconazole Treatment   [ Time Frame: Treatment week 12 ]

2.  Secondary:   Number of Participants Who Had Clinical Response at 4 Weeks With Posaconazole Treatment   [ Time Frame: Treatment week 4 ]

3.  Secondary:   Number of Participants Who Had Clinical Response at 8 Weeks With Posaconazole Treatment   [ Time Frame: Treatment week 8 ]

4.  Secondary:   Number of Participants With Pathogenic Fungal Eradication at 4 Weeks With Posaconazole Treatment   [ Time Frame: Treatment week 4 ]

5.  Secondary:   Number of Participants With Pathogenic Fungal Eradication at 8 Weeks With Posaconazole Treatment   [ Time Frame: Treatment week 8 ]

6.  Secondary:   Number of Participants With Pathogenic Fungal Eradication at 12 Weeks With Posaconazole Treatment   [ Time Frame: Treatment week 12 ]

7.  Secondary:   Number of Participant Survivors at Week 14 of Post-Posaconazole Treatment Follow-up   [ Time Frame: Follow-up week 14 ]


  Serious Adverse Events


  Other Adverse Events


  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: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00811642     History of Changes
Other Study ID Numbers: P05551
Study First Received: December 18, 2008
Results First Received: March 31, 2011
Last Updated: March 31, 2011
Health Authority: China: Food and Drug Administration