Fluconazole Pharmacokinetics in Infants

Completed

Conditions studied: Fungal Infection

In brief

The purpose of this study is to determine the pharmacokinetics of fluconazole in infants and evaluate the dose exposure relationship of current fluconazole dosing in infants who are receiving fluconazole for the prevention or treatment of systemic fungal infections.

Key facts

Study ID

NCT00514358

Run by

Children's Hospital of Philadelphia

People needed

55

Starts

2005-11-01

Expected to finish

2007-06-01

Last updated by the study team

2011-07-07

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Infant born >23 weeks gestational age with postnatal age <120 days
• Due to receive fluconazole therapy for clinical care
• Permission from attending neonatologist
• Informed consent of parent or legal guardian

Where it is running

• Children's Hospital of Michigan, Wayne State University — Detroit, Michigan, United States
• The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Texas Children's Hospital, Baylor College of Medicine — Houston, Texas, United States
• University of Utah — Salt Lake City, Utah, United States
• University of Virginia — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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