A Multiple-Dose Study To Evaluate The Pharmacokinetics And Safety Of Voriconazole In Immunocompromised Adolescents - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00556998

Purpose

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.

Condition	Intervention	Phase
Fungal Infection	Drug: Voriconazole	Phase I Phase II

MedlinePlus related topics: Fungal Infections Molds

Drug Information available for: Voriconazole

U.S. FDA Resources

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

Further study details as provided by Pfizer:

Primary Outcome Measures:

Pharmacokinetic parameters of voriconazole in adolescents compared to historical adult data. [ Time Frame: 14 to 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety and tolerability of voriconazole in adolescents [ Time Frame: 14 to 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	25
Study Start Date:	June 2008
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Voriconazole Voriconazole will be used for prophylaxis purpose

Eligibility

Ages Eligible for Study:	12 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00556998

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Locations

United States, Arizona
Pfizer Investigational Site	Recruiting
Phoenix, Arizona, United States, 85016
United States, Illinois
Pfizer Investigational Site	Recruiting
Chicago, Illinois, United States, 60637
United States, Louisiana
Pfizer Investigational Site	Recruiting
New Orleans, Louisiana, United States, 70118
United States, Massachusetts
Pfizer Investigational Site	Recruiting
Boston, Massachusetts, United States, 02111
United States, North Carolina
Pfizer Investigational Site	Recruiting
Durham, North Carolina, United States, 27705
United States, Ohio
Pfizer Investigational Site	Recruiting
Cleveland, Ohio, United States, 44106
United States, Oregon
Pfizer Investigational Site	Recruiting
Portland, Oregon, United States, 97239
United States, Tennessee
Pfizer Investigational Site	Recruiting
Nashville, Tennessee, United States, 37232
Pfizer Investigational Site	Recruiting
Nashville, Tennessee, United States, 37232-2195
United States, Texas
Pfizer Investigational Site	Recruiting
Fort Worth, Texas, United States, 76104-2796
Pfizer Investigational Site	Recruiting
Houston, Texas, United States, 77030

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A1501081
Study First Received:	November 9, 2007
Last Updated:	December 18, 2008
ClinicalTrials.gov Identifier:	NCT00556998
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

pharmacokinetics and safety data of voriconazole in immunocompromised adolescents

Study placed in the following topic categories:

Mycoses
Clotrimazole
Miconazole
Voriconazole
Tioconazole

Additional relevant MeSH terms:

Anti-Infective Agents
Communicable Diseases
Therapeutic Uses

Antifungal Agents
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009