Pharmacokinetics of Oseltamivir in Newborns and Infants

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Oseltamivir dosing in infants < 3 months of age is based on a single pharmacokinetic study in 20 infants from a single center. This dataset is limited by a lack of robustness, because only 1 sample was collected from each participant. The investigators obtained two blood samples each from infants receiving oseltamivir after obtaining informed consent from the infant's parents. The investigators propose to analyze the blood samples to determine the amount of oseltamivir in the infant's blood. Measurement of these values will increase the understanding of the absorption and elimination of oseltamivir in preterm and term infants, and improve our ability to provide the correct doses to this high risk population.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Louis Children's Hospital
• Collaborators: Genentech, Inc.; Washington University School of Medicine
• Treatments: Oseltamivir

Criteria

Inclusion Criteria:

• All neonates and infants in the NICU at St. Louis Children's Hospital who received oseltamivir for treatment of or exposure to influenza virus type A were considered eligible for this study.