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

August 8, 2007
July 6, 2011
November 2005
June 2007   (final data collection date for primary outcome measure)
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
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Complete list of historical versions of study NCT00514358 on ClinicalTrials.gov Archive Site
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Fluconazole Pharmacokinetics in Infants
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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

Fungal Infection
Not Provided
gestational age

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
June 2007
June 2007   (final data collection date for primary outcome measure)

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
Both
up to 119 Days
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00514358
PPRU10826
Yes
Kelly Wade, MD PhD, Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Pediatric Pharmacology Research Units Network
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
Children's Hospital of Philadelphia
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP