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Sponsors and Collaborators: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Pediatric Pharmacology Research Unit (PPRU) |
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Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
ClinicalTrials.gov Identifier: | NCT00514358 |
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.
Condition | Intervention | Phase |
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Fungal Infection |
Drug: Fluconazole |
Phase I |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | A Multicenter, Open Label Pharmacokinetic Study of Fluconazole in Infants |
Study Start Date: | November 2005 |
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
United States, Michigan | |
Children's Hospital of Michigan, Wayne State University | |
Detroit, Michigan, United States, 48201 | |
United States, Pennsylvania | |
The Children's Hospital of Philadelphia | |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, Texas | |
Texas Children's Hospital, Baylor College of Medicine | |
Houston, Texas, United States, 77030 | |
United States, Utah | |
University of Utah | |
Salt Lake City, Utah, United States, 84132 | |
United States, Virginia | |
University of Virginia | |
Charlottesville, Virginia, United States, 22908 |
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 |
Study ID Numbers: | PPRU10826 |
Study First Received: | August 8, 2007 |
Last Updated: | September 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00514358 |
Health Authority: | United States: Federal Government |
Fungal Infection sepsis pharmacokinetics |
Fluconazole Mycoses Sepsis |
Clotrimazole Miconazole Tioconazole |
Anti-Infective Agents Therapeutic Uses Antifungal Agents Infection Pharmacologic Actions |