Pharmacokinetic study of voriconazole in immunocompromised children aged 2 to <12 years

• Conditions: Invasive fungal infections; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2012-001133-14-Outside-EU/EEA
• Lead Sponsor: Pfizer Inc. 235 East 42nd Street, New York, NY 10017

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-06
• Last Update Posted: 20 March 2012

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

•Male or female from 2 to <12 years of age.
•Require treatment for the prevention of systemic fungal infection.
•Expected to develop neutropenia (ANC <500 cells/µL) lasting more than 10 days following chemotherapy.
•Anticipated to live for more than 3 months.

Are the trial subjects under 18? yes
Number of subjects for this age range: 40
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Evidence of any clinically significant liver or renal function or other abnormalities such as cardiac arrhythmia, hypokalemia, hypomagnesemia or hypocalcemia.
•Documented bacterial or viral infection not responding to appropriate treatment.
•Hypersensitivity to or severe intolerance of azole antifungal agents.
•Receiving other azoles or drugs that is are prohibited in the voriconazole label or associated.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified