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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00811642
First Posted: December 19, 2008
Last Update Posted: April 7, 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):
Merck Sharp & Dohme Corp.
Results First Submitted: March 31, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Fungal Infection
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
No text entered.

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 
Overall Participants Analyzed 
[Units: Participants]
 62 
Age 
[Units: Years]
Mean (Standard Deviation)
 40.41  (14.752) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      34  54.8% 
Male      28  45.2% 
Region of Enrollment 
[Units: Participants]
 
China   62 


  Outcome Measures
  Show All Outcome Measures

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


  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.
e-mail: ClinicalTrialsDisclosure@merck.com


Publications of Results:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00811642     History of Changes
Other Study ID Numbers: P05551
First Submitted: December 18, 2008
First Posted: December 19, 2008
Results First Submitted: March 31, 2011
Results First Posted: April 29, 2011
Last Update Posted: April 7, 2017