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

History of Changes

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
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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	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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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 ]

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2. Secondary:

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

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3. Secondary:

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

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4. Secondary:

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

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5. Secondary:

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

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6. Secondary:

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

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7. Secondary:

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

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Principal Investigator (PI) agrees not to publish or publicly present any interim results of the Protocol study without the prior written consent of the Sponsor. PI further agrees to provide to the Sponsor thirty (30) days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the Protocol study. The sponsor shall have editorial rights with respect to publications, abstracts, slides, and manuscripts.

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

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