This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.AbstractHypothesis: We hypothesize that more in depth pharmacokinetic analysis of fluconazole in infacnts receiving this drug will lead to both better understanding of adequate and safe fluconazole dosing in neonates, and also yield insight into how drug metabolism is affected by gestation age, postnatal age, kidney function, sugery, and concomitant medications.
Specific Aims : 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.Background And Significance: 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 (NICUs) has contributed not only to iimproved 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 fungal colonization and systemic infection; however, we do not have sufficient pharmacokinetic information in nonates. In this study, we will perform a classic pharmacokinetic study in neonates receiving fluconazole. Fluconazole levels will be measured using a liquid chromatography/tandem mass spectroscopy (LC/MS/MS) assay from very small quantities of blook 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.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000188-44
Application #
7717688
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2007-12-01
Project End
2008-11-30
Budget Start
2007-12-01
Budget End
2008-11-30
Support Year
44
Fiscal Year
2008
Total Cost
$33
Indirect Cost
Name
Baylor College of Medicine
Department
Pediatrics
Type
Schools of Medicine
DUNS #
051113330
City
Houston
State
TX
Country
United States
Zip Code
77030
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