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

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00174473
• Collaborator: (none)
• Enrollment: 49
• Duration (Months): 26

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Neutropenia	Drug: Voriconazole	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 49 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-label, Intravenous to Oral Switch, Multiple Dose Multi-Centre Study to Investigate the Pharmacokinetics, Safety and Tolerability of Voriconazole in Hospitalized Children Aged 2 to 12 Years Who Require Treatment for the Prevention of Systemic Fungal Infections.
• Study Start Date: Jun 1, 2003
• Actual Study Completion Date: Aug 1, 2005

Outcome Measures

Primary Outcome Measures

1. 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

1. 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. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 12 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00174473
• Other Study ID Numbers: A1501037
• First Posted: Sep 15, 2005
• Last Update Posted: May 10, 2011
• Last Verified: May 1, 2011

• Additional relevant MeSH terms: Neutropenia; Voriconazole

Study Results

No Results Posted as of May 10, 2011