A Multiple-Dose Study To Evaluate The Pharmacokinetics And Safety Of Voriconazole In Immunocompromised Adolescents

Pfizer

Status and phase: Completed; Phase 2

Conditions: Pharmacokinetics

Treatments: Drug: Voriconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00556998

A1501081

Details and patient eligibility

About

This study is designed to collect additional pharmacokinetic and safety data of voriconazole in immunocompromised adolescents receiving intravenous and oral voriconazole. This will help establish voriconazole dosing recommendations for adolescents.

Enrollment: 26 patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects who are expected to develop neutropenia following chemotherapy.
• Subjects who require treatment for the prevention of systemic fungal infection.

Exclusion criteria

• Subjects with a history of severe intolerance of azole antifungal agents.
• Subjects with documented bacterial or viral infection at the time of study entry who are not responding to appropriate treatment against the infection.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

1

Experimental group

Treatment:

Drug: Voriconazole