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NCT00514358 Clinical Trial

Fluconazole Pharmacokinetics in Infants

Fungal Infection Clinical Trial

Official title:
A Multicenter, Open Label Pharmacokinetic Study of Fluconazole in Infants

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00514358
Other study ID # PPRU10826
Secondary ID
Status Completed
Phase Phase 1
First received August 8, 2007
Last updated July 6, 2011
Start date November 2005
Est. completion date June 2007

Study information
Verified date July 2011
Source Children's Hospital of Philadelphia
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 55
Est. completion date June 2007
Est. primary completion date June 2007
Accepts healthy volunteers No
Gender Both
Age group N/A to 119 Days
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Sponsors (3)
Lead Sponsor Collaborator
Children's Hospital of Philadelphia Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Pediatric Pharmacology Research Units Network

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. doi: 10.1 — View Citation

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 pharmacokine — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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. PK blood samples obtained over 3 weeks in infants receiving fluconazole as standard of care 3 weeks No
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