Fluconazole Pharmacokinetics in Infants
Information source: National Institute of Child Health and Human Development (NICHD)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Fungal Infection
Intervention: Fluconazole (Drug)
Phase: Phase 1
Status: Active, not recruiting
Sponsored by: National Institute of Child Health and Human Development (NICHD) Official(s) and/or principal investigator(s):
Kelly C. Wade, M.D., Ph.D., Principal Investigator, Affiliation: Children's Hospital of Philadelphia
Peter C Adamson, M.D., Principal Investigator, Affiliation: Children's Hospital of Philadelphia
Jeffery Barrett, Ph.D., Principal Investigator, Affiliation: Children's Hospital of Philadelphia
Summary
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.
Clinical Details
Official title: A Multicenter, Open Label Pharmacokinetic Study of Fluconazole in Infants
Study design: Screening, Longitudinal, Defined Population, Prospective Study
Detailed description:
Systemic fungal infections in neonates are associated with high morbidity and mortality. The
increasing use of intravenous central catheters, parenteral nutrition, and antibiotics in
neonatal intensive care units has contributed not only to improved survival but also to the
increasing incidence of fungal sepsis particularly in preterm infants. Decreasing fungal
colonization can decrease the risk of systemic fungal infection. Fluconazole is a potent
antifungal agent in the triazole family. Fluconazole has been shown to reduce the risk of
fungal colonization and systemic infection however we do not have sufficient pharmacokinetic
information in neonates to support dosing guidelines. In this study, we will perform a
population pharmacokinetic study in neonates receiving fluconazole as standard of care.
Fluconazole levels will be measured using a liquid chromatography/tandem mass spectroscopy
(LC/MS/MS) assay from very small quantities of blood appropriate for neonates.
Pharmacokinetic data obtained in this study will support appropriate dosing of fluconazole in
neonates and provide information regarding drug metabolism in neonates.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Infant born >23 weeks gestational age with postnatal age <120 days
2. Due to receive fluconazole therapy for clinical care
3. Permission from attending neonatologist
4. Informed consent of parent or legal guardian
Locations and Contacts
Children's Hospital of Michigan, Wayne State University, Detroit, Michigan 48201, United States
The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 19104, United States
Texas Children's Hospital, Baylor College of Medicine, Houston, Texas 77030, United States
University of Utah, Salt Lake City, Utah 84132, United States
University of Virginia, Charlottesville, Virginia 22908, United States
Additional Information
Pediatric Pharmacology Research Unit Web site
Starting date: November 2005
Last updated: August 8, 2007
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