Official Title: “An Open-Label, Intravenous To Oral Switch, Multiple Dose Study To Evaluate The Pharmacokinetics, Safety And Tolerability Of Voriconazole In Immunocompromised Adolescents Aged 12 To <17 Years Who Are At High Risk For Systemic Fungal Infection”

This study is designed to collect additional pharmacokinetic and safety data of voriconazole in immunocompromised adolescents receiving intravenous and oral voriconazole. This will help establish voriconazole dosing recommendations for adolescents.

Study Type: Interventional

Study Design: Prevention, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study

Study Primary Completion Date: September 2009

Intervention(s) in this Clinical Trial

• Drug: Voriconazole
  • Voriconazole will be used for prophylaxis purpose

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1

Primary Measures

• Pharmacokinetic parameters of voriconazole in adolescents compared to historical adult data.
  • Time Frame: 14 to 30 days
    Safety Issue?: No

Secondary Measures

• Safety and tolerability of voriconazole in adolescents
  • Time Frame: 14 to 30 days
    Safety Issue?: Yes

Inclusion Criteria:

• Subjects who are expected to develop neutropenia following chemotherapy.
• Subjects who require treatment for the prevention of systemic fungal infection.

Exclusion Criteria:

• Subjects with a history of severe intolerance of azole antifungal agents.
• Subjects with documented bacterial or viral infection at the time of study entry who are not responding to appropriate treatment against the infection.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: 17 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Overall Contact: Pfizer CT.gov Call Center 1-800-718-1021 

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00556998

Study ID Number: A1501081

ClinicalTrials.gov Identifier: NCT00556998

Health Authority: United States: Food and Drug Administration

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