Pharmacokinetic Study of Fluconazole in Premature Infants | NCT01683760 | Trialant
CompletedInterventionalPhase 2Updated Nov 19, 2014
Pharmacokinetic Study of Fluconazole in Premature Infants
ClinicalTrials.gov ID
NCT01683760
Lead Sponsor
Seoul National University HospitalOTHER
Overall Status
Completed
Study Type
Interventional
Phase
Phase 2
Enrollment
80Actual
Last Update Posted
Nov 19, 2014Estimated
Start Date
Sep 2012
Primary Completion Date
Oct 2014Actual
Completion Date
Oct 2014Actual
Brief Summary
The purpose of this study is to investigate the pharmacokinetics of fluconazole which is used as prophylaxis of invasive fungal infection in premature infants.
Very Low Birth Weight Infant
Fluconazole
Ages Eligible for Study
Child (0-17)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
very low birth weight infant (birth weight < 1,500 g) who were admitted to the NICU before day 3 of life
Informed consent from the parents
Exclusion Criteria:
Major congenital anomaly
Expired within 72 hours of life
Liver failure (AST or ALT levels with three times the upper limit of the range of normal values or higher)
Proven congenital or intrauterine fungal infection