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Fluconazole Pharmacokinetics in Infants
This study has been completed.
Sponsors and Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Pediatric Pharmacology Research Unit (PPRU)
Information provided by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00514358
  Purpose

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.


Condition Intervention Phase
Fungal Infection
Drug: Fluconazole
Phase I

MedlinePlus related topics: Fungal Infections Molds
Drug Information available for: Fluconazole
U.S. FDA Resources
Study Type: Observational
Study Design: Prospective
Official Title: A Multicenter, Open Label Pharmacokinetic Study of Fluconazole in Infants

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • 1. To develop a population model of fluconazole drug disposition in premature infants who are receiving fluconazole for treatment or prophylaxis against systemic fungal infections.
  • 2. To determine if current dosing provides for adequate and safe fluconazole exposure.

Study Start Date: November 2005
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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00514358

Locations
United States, Michigan
Children's Hospital of Michigan, Wayne State University
Detroit, Michigan, United States, 48201
United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Texas Children's Hospital, Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
Pediatric Pharmacology Research Unit (PPRU)
Investigators
Principal Investigator: Kelly C. Wade, M.D., Ph.D. Children's Hospital of Philadelphia
Principal Investigator: Peter C Adamson, M.D. Children's Hospital of Philadelphia
Principal Investigator: Jeffery Barrett, Ph.D. Children's Hospital of Philadelphia
  More Information

Pediatric Pharmacology Research Unit Web site  This link exits the ClinicalTrials.gov site

Study ID Numbers: PPRU10826
Study First Received: August 8, 2007
Last Updated: September 25, 2008
ClinicalTrials.gov Identifier: NCT00514358  
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Fungal
Infection
sepsis
pharmacokinetics

Study placed in the following topic categories:
Fluconazole
Mycoses
Sepsis
Clotrimazole
Miconazole
Tioconazole

Additional relevant MeSH terms:
Anti-Infective Agents
Therapeutic Uses
Antifungal Agents
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009