Fluconazole Pharmacokinetics in Infants

This study has been completed.
Sponsor:
Collaborators:
Pediatric Pharmacology Research Units Network
Information provided by:
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT00514358
First received: August 8, 2007
Last updated: July 6, 2011
Last verified: July 2011
  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 Phase
Fungal Infection
Phase 1

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multicenter, Open Label Pharmacokinetic Study of Fluconazole in Infants

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome 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 ] [ Designated as safety issue: No ]
    PK blood samples obtained over 3 weeks in infants receiving fluconazole as standard of care


Enrollment: 55
Study Start Date: November 2005
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
gestational age

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

Ages Eligible for Study:   up to 119 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Premature and term infants less than 90 days of age who are receiving fluconazole as standard of care therapy.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Children's Hospital of Philadelphia
Pediatric Pharmacology Research Units Network
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

Additional Information:
Publications:
Responsible Party: Kelly Wade, MD PhD, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00514358     History of Changes
Other Study ID Numbers: PPRU10826
Study First Received: August 8, 2007
Last Updated: July 6, 2011
Health Authority: United States: Federal Government

Keywords provided by Children's Hospital of Philadelphia:
Fungal
Infection
sepsis
pharmacokinetics

Additional relevant MeSH terms:
Infection
Mycoses
Fluconazole
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014