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A 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
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neutropenia

Eligibility Criteria

2 Years - 12 Years (Child)All SexesDoes not accept 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.

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

    First Posted
    September 12, 2005
    Last Updated
    May 9, 2011
    Sponsor
    Pfizer
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    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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