Back to resultsA Study to Investigate the Pharmacokinetics, Safety and Tolerability of Voriconazole in Children
Primary Purpose
Neutropenia
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Voriconazole
Sponsored by
About this trial
This is an interventional treatment trial for Neutropenia
Eligibility Criteria
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.
Sites / Locations
Outcomes
Primary Outcome Measures
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00174473
Brief Title
A Study to Investigate the Pharmacokinetics, Safety and Tolerability of Voriconazole in Children
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 Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neutropenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Voriconazole
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Study to Investigate the Pharmacokinetics, Safety and Tolerability of Voriconazole in Children
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