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

This study has been completed.

Study NCT00726609 Information provided by Schering-Plough

First Received on July 30, 2008. Last Updated on January 14, 2010 History of Changes

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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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. ]

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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 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.

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: Head Clinical Trials Registry & Results Disclosure Group
Organization: Schering-Plough
e-mail: ClinicalTrialsDisclosure@spcorp.com

No publications provided

Responsible Party:	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
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:	January 14, 2010
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices