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Pharmacokinetics of Oseltamivir in Newborns and Infants

Information source: St. Louis Children's Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prematurity of Fetus

Intervention: Oseltamivir (Drug)

Phase: N/A

Status: Completed

Sponsored by: St. Louis Children's Hospital


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.

Clinical Details

Official title: Pharmacokinetics of Oseltamivir in Newborns and Infants

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Oseltamivir pharmacokinetics in neonates and infants

Secondary outcome: Oseltamivir target level attainment


Minimum age: N/A. Maximum age: 6 Months. Gender(s): Both.


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.

Locations and Contacts

St. Louis Children's Hosptial, St. Louis, Missouri 63110, United States
Additional Information

Related publications:

Acosta EP, Jester P, Gal P, Wimmer J, Wade J, Whitley RJ, Kimberlin DW; National Institute of Allergy and Infectious Diseases Collaborative Antiviral Study Group. Oseltamivir dosing for influenza infection in premature neonates. J Infect Dis. 2010 Aug 15;202(4):563-6. doi: 10.1086/654930.

Fiore AE, Fry A, Shay D, Gubareva L, Bresee JS, Uyeki TM; Centers for Disease Control and Prevention (CDC). Antiviral agents for the treatment and chemoprophylaxis of influenza --- recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2011 Jan 21;60(1):1-24.

Starting date: January 2011
Last updated: July 5, 2011

Page last updated: August 23, 2015

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