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

NCT00726609 | Completed Results

• 1 other identifier: P04641
• Study Type: observational
• Target: 214
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Mycoses

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Posaconazole (assigned by physician in normal practice)

* Treatment of invasive fungal infection. * Prophylaxis of invasive fungal infection.

Drug: Posaconazole

Interventions

Posaconazole 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.

Also known as: SCH 56592, NOXAFIL®

Posaconazole (assigned by physician in normal practice)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects with invasive fungal infection refractory to first-line treatment or unable to tolerate it were selected at hospitals in Germany. Following the enlargement of the marketing authorization for posaconazole, subjects at risk for invasive fungal infection were also enrolled.

You may qualify if:

• 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.

You may not qualify if:

• Comedication of the participant with ergotamine, dihydroergotamine, terfenadine, astemizole, cisapride, pimozide, halofantrine, or chinidine.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Mycoses

Interventions

posaconazole

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2008
• First Posted: August 1, 2008
• Study Start: January 1, 2006
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: March 5, 2015
• Results First Posted: September 22, 2009

Record last verified: 2015-02