N/A
Completed N=214
Post-marketing Surveillance Study of Invasive Mycosis With Posaconazole (Study P04641)
Mycoses
Source: ClinicalTrials.gov NCT00726609 ↗
Enrolled (actual)
214
Serious AEs
15.4%
Results posted
Sep 2009
Primary outcomePrimary: Number of Participants Reporting Adverse Drug Reactions. — 52; 30; 21; 1 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reporting Adverse Drug Reactions. |
52; 30; 21; 1 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00726609). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.