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

Merck Sharp & Dohme (MSD)

Status: Completed

Conditions: Mycoses

Treatments: Drug: Posaconazole

Study type: Observational

Funder types: Industry

Identifiers

NCT00726609

P04641

Details and patient eligibility

About

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.

Full 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.

Enrollment: 214 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

214 participants in 1 patient group

Posaconazole (assigned by physician in normal practice)

Description:

* Treatment of invasive fungal infection. * Prophylaxis of invasive fungal infection.

Treatment:

Drug: Posaconazole