Fluconazole Pharmacokinetics 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.

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Key information

Conditions

Fungal Infection Bacterial Infections and Mycoses Infections Inflammation Mycoses Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

Up to 119 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital of Michigan, Wayne State University, Detroit, Michigan, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Infant born >23 weeks gestational age with postnatal age <120 days
Due to receive fluconazole therapy for clinical care
Permission from attending neonatologist
Informed consent of parent or legal guardian

Treatment and study plan

Primary outcomes

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

PK blood samples obtained over 3 weeks in infants receiving fluconazole as standard of care

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Pediatric Pharmacology Research Units Network

Registry information

Official study title

A Multicenter, Open Label Pharmacokinetic Study of Fluconazole in Infants

Important dates

Study start: 2005
Primary completion: 2007
Study completion: 2007
First posted: Aug 9, 2007
Registry last updated: Jul 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed