Postmarketing Surveillance Study on the Labeled Use of Oral Posaconazole 40 mg/mL Suspension (Study P04641)

Condition(s) targeted: Mycoses

Intervention: Posaconazole (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Schering-Plough

Overall contact:
SP Clinical Trial Registry Call Center, Phone: 1-888-772-8734

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 efficacy and safety of NOXAFIL® (posaconazole) in the treatment of invasive fungal disease.

Official title: Postmarketing Surveillance Study on the Labeled Use of NOXAFIL® 40 mg/mL Suspension for Oral Use

Study design: Case-Only, Prospective

Primary outcome: Safety: Adverse Reactions occurring during therapy.

Secondary outcome: Efficacy: therapy outcome Usage of posaconazole in clinical practice.

Detailed description: Data regarding demographics, underlying disease, prior fungal infection, prior antifungal medication, IFI signs & symptoms, concomitant medication, posaconazole use, tolerability, safety and therapy outcome is collected on abstracted eCRFs. This surveillance is limited to patients receiving posaconazole as salvage antifungal therapy as indicated.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Adult subjects with invasive aspergillosis, fusariosis, chromoblastomycosis, mycetoma

or coccidiomycosis resistant to, or intolerant of, treatment with amphotericin B, itraconazole or fluconazole.

Resistance to treatment is defined as progression of infection or no response after at least 7 days of an effective antifungal treatment administered at therapeutic doses.

Exclusion Criteria:

- N/A. The treating physician decides upon the use of posaconazole according to label.

SP Clinical Trial Registry Call Center, Phone: 1-888-772-8734

Coordinating Location, Munich, Germany; Recruiting

Starting date: November 2005
Ending date: October 2008
Last updated: July 31, 2008