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

Neutropenia Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00174473
• Other study ID #: A1501037
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 12, 2005
• Last updated: May 9, 2011
• Start date: June 2003
• Est. completion date: August 2005

Study information

• Verified date: May 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 12 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neutropenia

Intervention

Drug:
• Voriconazole

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary objective was to investigate the pharmacokinetics of voriconazole following intravenous (iv) to oral administration in immunocompromised children aged 2 to <12years.
Secondary	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.