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: Prospective

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.

Intervention(s) in this Clinical Trial

• Drug: Fluconazole

Primary 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.

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: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Institute of Child Health and Human Development (NICHD)

Overall Clinical Trial Officials and Contacts

Kelly C. Wade, M.D., Ph.D. Principal Investigator Children's Hospital of Philadelphia  

Information obtained from ClinicalTrials.gov on October 10, 2008

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

Pediatric Pharmacology Research Unit Web site