Fluconazole Pharmacokinetics in Infants

A Multicenter, Open Label Pharmacokinetic Study of Fluconazole in Infants

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00514358

Enrollment

Registered

2007-08-09

Start date

2005-11-30

Completion date

2007-06-30

Last updated

2011-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fungal Infection

Keywords

Fungal, Infection, sepsis, pharmacokinetics

Brief summary

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 119 Days

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.	3 weeks	PK blood samples obtained over 3 weeks in infants receiving fluconazole as standard of care

Countries

United States

Outcome results