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

Phase 1

Completed

• Conditions: Neutropenia

• Registration Number: NCT00174473
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-06
• Study Completion: 2005-08
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-15
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-09
• Last Update Posted: 2011-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.