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

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Posaconazole

Criteria

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.