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

Mycoses Clinical Trial

Official title:
Post-marketing Surveillance (PMS) Management of Invasive Mycosis With Posaconazole

Clinical Trial Summary

The purpose of this postmarketing surveillance study is to collect an extensive body of data in a large patient population in every day life to investigate the safety and efficacy of NOXAFIL® (posaconazole) in the treatment of invasive fungal disease.

Clinical Trial Description

Data regarding demographics, underlying disease, prior fungal infection, prior antifungal medication, invasive fungal infection signs & symptoms, concomitant medication, posaconazole use, tolerability, safety and therapy outcome will be collected on abstracted electronic Case Report Forms.

This surveillance study was originally limited to subjects receiving posaconazole as salvage antifungal therapy as indicated. A subgroup of subjects at risk for invasive fungal infection was included for prophylactic treatment following the enlargement of the marketing authorization for NOXAFIL® (posaconazole) during the course of the study. These participants only contributed data for the assessment of safety. ;

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00726609
Study type Observational
Source Merck Sharp & Dohme Corp.
Contact
Status Completed
Phase N/A
Start date January 2006
Completion date July 2008
View Details
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