N/A N=214

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

Mycoses

Bottom Line

View on ClinicalTrials.gov: NCT00726609 ↗

Enrolled (actual)

214

Serious AEs

15.4%

Results posted

Sep 2009

Primary outcome: Primary: Number of Participants Reporting Adverse Drug Reactions. — 52; 30; 21; 1 Participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Posaconazole (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Merck Sharp & Dohme LLC
Primary completion: Jul 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Reporting Adverse Drug Reactions.	52; 30; 21; 1	—

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.

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.

View full record on ClinicalTrials.gov →

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.