A Study to Investigate the Pharmacokinetics, Safety and Tolerability of Voriconazole in Children

Pfizer49 enrolled

Overview

This is a study to investigate the pharmacokinetics, safety and tolerability of several doses of voriconazole, intravenous and oral suspension formulations, in children

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neutropenia

Interventions

VoriconazoleDRUG

Eligibility

Sex: ALLMin age: 2 YearsMax age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Children who require a systemic antifungal agent for the prevention of systemic fungal infection Exclusion Criteria: * Children who are receiving medications which cannot be taken concomitantly with voriconazole.

Outcomes

Primary Outcomes

The primary objective was to investigate the pharmacokinetics of voriconazole following intravenous (iv) to oral administration in immunocompromised children aged 2 to <12years.

Secondary Outcomes

The secondary objective was to evaluate the safety and tolerability of multiple dose administration of voriconazole in immunocompromised children requiring treatment for the prevention of systemic fungal infection.

Data from ClinicalTrials.gov

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