Fluconazole Pharmacokinetics in Infants
A Multicenter, Open Label Pharmacokinetic Study of Fluconazole in Infants
1 other identifier
observational
55
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2005
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 8, 2007
CompletedFirst Posted
Study publicly available on registry
August 9, 2007
CompletedJuly 7, 2011
July 1, 2011
1.6 years
August 8, 2007
July 6, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
gestational age
Eligibility Criteria
Premature and term infants less than 90 days of age who are receiving fluconazole as standard of care therapy.
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Children's Hospital of Michigan, Wayne State University
Detroit, Michigan, 48201, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Texas Children's Hospital, Baylor College of Medicine
Houston, Texas, 77030, United States
University of Utah
Salt Lake City, Utah, 84132, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Related Publications (2)
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: 10.1097/INF.0b013e31819f1f50.
PMID: 19593252RESULTWade 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 pharmacokinetics of fluconazole in young infants. Antimicrob Agents Chemother. 2008 Nov;52(11):4043-9. doi: 10.1128/AAC.00569-08. Epub 2008 Sep 22.
PMID: 18809946RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 8, 2007
First Posted
August 9, 2007
Study Start
November 1, 2005
Primary Completion
June 1, 2007
Study Completion
June 1, 2007
Last Updated
July 7, 2011
Record last verified: 2011-07