Fluconazole Pharmacokinetics in Infants
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...
Brief Summary
Official Title: “A Multicenter, Open Label Pharmacokinetic Study of Fluconazole in Infants”
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.
- Study Type: Observational
- Study Design: Observational Model: Cohort, Time Perspective: Prospective
- Study Primary Completion Date: June 2007
Detailed Clinical Trial 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.
Arms, Groups and Cohorts in this Clinical Trial
- : gestational age
Outcome Measures for this Clinical Trial
Primary Measures
- To develop a population PK model of fluconazole drug disposition in premature infants who are receiving fluconazole for treatment or prophylaxis against systemic fungal infections.
- Time Frame: 3 weeks
Safety Issue?: No
- Time Frame: 3 weeks
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: N/A
Maximum Age for this Clinical Trial: 119 Days
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Children's Hospital of Philadelphia Other
Overall Clinical Trial Officials and Contacts
Kelly C. Wade, M.D., Ph.D. Principal Investigator Children's Hospital of Philadelphia
Related Publications
Citations Reporting Results
Wade KC, Benjamin DK Jr, Kaufman DA, Ward RM, Smith PB, Jayaraman B, Adamson PC, Gastonguay MR, Barrett JS. Fluconazole dosing for the prevention or treatment of invasive candidiasis in young infants. Pediatr Infect Dis J. 2009 Aug;28(8):717-23.
Wade KC, Wu D, Kaufman DA, Ward RM, Benjamin DK Jr, Sullivan JE, Ramey N, Jayaraman B, Hoppu K, Adamson PC, Gastonguay MR, Barrett JS; National Institute of Child Health and Development Pediatric Pharmacology Research Unit Network. Population pharmacokinetics of fluconazole in young infants. Antimicrob Agents Chemother. 2008 Nov;52(11):4043-9. Epub 2008 Sep 22.
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00514358
Study ID Number: PPRU10826
ClinicalTrials.gov Identifier: NCT00514358
Health Authority: United States: Federal Government
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00514358
