NCT00726609

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 214 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Mycoses

Interventions

Type	Name	Description
DRUG	Posaconazole	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.

Timeline

• Start date: 2006-01-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2008-08-01
• Last updated: 2015-03-05
• Results posted: 2009-09-22