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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Mycoses

Intervention / Treatment
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* Drug: Posaconazole


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Posaconazole (assigned by physician in normal practice)<br>Treatment of invasive fungal infection. Prophylaxis of invasive fungal infection. | Drug: Posaconazole<br>* 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.<br>* Other names: NOXAFIL®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Reporting Adverse Drug Reactions. | 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. | Before starting treatment with posaconazole, during treatment, and until 100 days after treatment. |