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

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.

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00174473

Enrollment

Registered

2005-09-15

Start date

2003-06-30

Completion date

2005-08-31

Last updated

2011-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neutropenia

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

Interventions

DRUGVoriconazole

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

2 Years to 12 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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.	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026