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

NCT ID: NCT00726609

Last Updated: 2015-03-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 214 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2008-07-31

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® (posaconazole) in the treatment of invasive fungal disease.

Detailed 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.

Conditions

Mycoses

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Posaconazole (assigned by physician in normal practice)

• Treatment of invasive fungal infection.
• Prophylaxis of invasive fungal infection.

Posaconazole

Intervention Type: DRUG

The usual dose of NOXAFIL® is 400 mg twice daily (10 mL) at meals or with 240 mL of a food supplement. For patients unable to take meals or food supplements, NOXAFIL® is administered at a dose of 200 mg (5 mL) four times daily.

Interventions

Posaconazole

The usual dose of NOXAFIL® is 400 mg twice daily (10 mL) at meals or with 240 mL of a food supplement. For patients unable to take meals or food supplements, NOXAFIL® is administered at a dose of 200 mg (5 mL) four times daily.

Intervention Type: DRUG

Other Intervention Names

SCH 56592; NOXAFIL®

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

P04641

Identifier Type: -

Identifier Source: org_study_id