Post-marketing Surveillance Study of Invasive Mycosis With Posaconazole (Study P04641)
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Post-marketing Surveillance (PMS) Management of Invasive Mycosis With Posaconazole|
- Number of Participants Reporting Adverse Drug Reactions. [ Time Frame: Before starting treatment with posaconazole, during treatment, and until 100 days after treatment. ] [ Designated as safety issue: Yes ]
The severity of an Adverse Drug Reaction is determined on the basis of the following definitions:
Mild: The abnormality, symptom or event is noticed but well tolerated.
Moderate: Symptoms impair normal activities and may require intervention.
Severe: Clinical status is significantly impaired, normal activity is no longer possible, intervention is required.
|Study Start Date:||January 2006|
|Study Completion Date:||July 2008|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
Posaconazole (assigned by physician in normal practice)
The usual dose of NOXAFIL® is 400 mg twice daily (10 mL) at meals or with 240 mL of a food supplement. For patients unable to take meals or food supplements, NOXAFIL® is administered at a dose of 200 mg (5 mL) four times daily.
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.