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

Completed

• Conditions: Mycoses
• Interventions: Drug: Posaconazole

• Registration Number: NCT00726609
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief 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.

Study Timeline

• Study Start: 2006-01
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Study First Submitted: 2008-07-30
• Study First Submitted QC: 2008-07-31
• Study First Posted: 2008-08-01
• Results First Submitted: 2009-08-13
• Results First Submitted QC: 2009-08-13
• Results First Posted: 2009-09-22
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-16
• Last Update Posted: 2015-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 214

Inclusion Criteria

Adult subjects with:

• Invasive aspergillosis refractory to, or intolerant of, amphotericin B or itraconazole,
• Fusariosis refractory to, or intolerant of, amphotericin B,
• Chromoblastomycosis and mycetoma refractory to, or intolerant of, itraconazole,
• Coccidiomycosis refractory to, or intolerant of, amphotericin B, itraconazole or fluconazole.
• Subjects receiving remission-induction chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk for developing invasive fungal infections.
• Hematopoietic stem-cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for Graft-versus-host disease and who are at high risk for developing invasive fungal infections.

Exclusion Criteria

• Comedication of the participant with ergotamine, dihydroergotamine, terfenadine, astemizole, cisapride, pimozide, halofantrine, or chinidine.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Posaconazole (assigned by physician in normal practice)	Posaconazole	* Treatment of invasive fungal infection. * Prophylaxis of invasive fungal infection.

Primary Outcome Measures

Name	Time	Method
Number of Participants Reporting Adverse Drug Reactions.	Before starting treatment with posaconazole, during treatment, and until 100 days after treatment.	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.