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

Mycoses Clinical Trial

Official title:

Post-marketing Surveillance (PMS) Management of Invasive Mycosis With Posaconazole

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00726609
• Other study ID #: P04641
• Status: Completed
• Phase: N/A
• First received: July 30, 2008
• Last updated: February 16, 2015
• Start date: January 2006
• Est. completion date: July 2008

Study information

• Verified date: February 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Mycoses

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Reporting Adverse Drug Reactions.	The severity of an Adverse Drug Reaction is determined on the basis of the following definitions: Mild: The abnormality, symptom or event is noticed but well tolerated.; Moderate: Symptoms impair normal activities and may require intervention.; Severe: Clinical status is significantly impaired, normal activity is no longer possible, intervention is required.	Before starting treatment with posaconazole, during treatment, and until 100 days after treatment.	Yes