Status:
COMPLETED
Post-marketing Surveillance Study of Invasive Mycosis With Posaconazole (Study P04641)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Mycoses
Eligibility:
All Genders
18+ years
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® (posacon...
Detailed Description
Data regarding demographics, underlying disease, prior fungal infection, prior antifungal medication, invasive fungal infection signs \& symptoms, concomitant medication, posaconazole use, tolerabilit...
Eligibility Criteria
Inclusion
- 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
- Comedication of the participant with ergotamine, dihydroergotamine, terfenadine, astemizole, cisapride, pimozide, halofantrine, or chinidine.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
214 Patients enrolled
Trial Details
Trial ID
NCT00726609
Start Date
January 1 2006
End Date
July 1 2008
Last Update
March 5 2015
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