Pharmacokinetics of Oseltamivir in Newborns and Infants

CompletedOBSERVATIONAL
Enrollment

19

Participants

Timeline

Start Date

January 31, 2011

Primary Completion Date

January 31, 2011

Study Completion Date

January 31, 2011

Conditions
Prematurity of Fetus
Interventions
DRUG

Oseltamivir

Treatment dose was oseltamivir 3 mg/kg/dose by mouth (PO) twice daily. Prophylactic dose was oseltamivir 1 mg/kg/dose PO once daily to infants \< 28 weeks postmenstrual age (PMA), 1 mg/kg/dose PO twice daily to infants 28 - 38 weeks PMA, and 3 mg/kg/dose PO once daily to infants \> 38 weeks PMA. Dosing in infants \< 28 weeks PMA was chosen based on unpublished data from Acosta et al. This data was obtained from phone contact with Dr. Peter Gal, co-author of the study. Dosing in infants 28 - 38 weeks PMA was chosen based on published data from Acosta et al.1 Dosing in infants \> 38 weeks PMA and less than 3 months postnatal age was chosen based on data from Kimberlin et al. Dosing in infants \> 38 weeks PMA and greater than 3 months postnatal age was per the recommendations of the Advisory Committee on Immunization Practices of the United States Department of Health and Human Services.

Trial Locations (1)

63110

St. Louis Children's Hosptial, St Louis

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Genentech, Inc.

INDUSTRY

collaborator

Washington University School of Medicine

OTHER

lead

St. Louis Children's Hospital

OTHER