Fungal Infection Clinical Trial
Official title:
A Multicenter, Open Label Pharmacokinetic Study of Fluconazole in Infants
Verified date | July 2011 |
Source | Children's Hospital of Philadelphia |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Observational |
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.
Status | Completed |
Enrollment | 55 |
Est. completion date | June 2007 |
Est. primary completion date | June 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 119 Days |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | University of Virginia | Charlottesville | Virginia |
United States | Children's Hospital of Michigan, Wayne State University | Detroit | Michigan |
United States | Texas Children's Hospital, Baylor College of Medicine | Houston | Texas |
United States | The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
United States | University of Utah | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital of Philadelphia | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Pediatric Pharmacology Research Units Network |
United States,
Wade KC, Benjamin DK Jr, Kaufman DA, Ward RM, Smith PB, Jayaraman B, Adamson PC, Gastonguay MR, Barrett JS. Fluconazole dosing for the prevention or treatment of invasive candidiasis in young infants. Pediatr Infect Dis J. 2009 Aug;28(8):717-23. doi: 10.1 — View Citation
Wade KC, Wu D, Kaufman DA, Ward RM, Benjamin DK Jr, Sullivan JE, Ramey N, Jayaraman B, Hoppu K, Adamson PC, Gastonguay MR, Barrett JS; National Institute of Child Health and Development Pediatric Pharmacology Research Unit Network. Population pharmacokine — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | PK blood samples obtained over 3 weeks in infants receiving fluconazole as standard of care | 3 weeks | No |
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