Pharmacokinetics of Oseltamivir in Newborns and Infants

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.

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Key information

Conditions

Prematurity of Fetus Female Urogenital Diseases and Pregnancy Complications Infections Influenza, Human Obstetric Labor Complications Obstetric Labor, Premature Orthomyxoviridae Infections Pregnancy Complications Premature Birth RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Urogenital Diseases Virus Diseases

Age range

Up to 6 month

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Louis Children's Hosptial

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

oseltamivir

Drug

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 28 weeks PMA was chosen based on unpublished data from Acosta et al.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.

Primary outcomes

Oseltamivir pharmacokinetics in neonates and infants

Time frame: Two sample points, one 0-3 hours (baseline) and one 3-24 hours post dose

Pharmacokinetic parameters calculated for individual subjects will include apparent distribution volume and elimination half-life of oseltamivir (OST) and OST carboxylate (CBX). Area under the plasma concentration versus time curve (AUC) of OST and OST CBX will be determined using the trapezoidal method. A population pharmacokinetic model will be generated based on pooled pharmacokinetic data (2-compartment model for OST and 1-compartment model for OST CBX) utilizing maximum likelihood estimation. A weight-based dosing table will be generated to provide AUC exposures comparable to adults.

Secondary outcomes

Oseltamivir target level attainment

Time frame: Two sample points, one 0-3 hours (baseline) and one 3-24 hours post dose

OST target level attainment of the currently recommended dosing regimen in neonates and infants will be calculated. Currently recommended doses were utilized for all neonates and infants in our cohort. The target level attainment in this cohort will be calculated.

Sponsors and collaborators

Lead sponsor

St. Louis Children's Hospital

Other

Collaborators

Genentech, Inc.
Washington University School of Medicine

Registry information

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2011
First posted: Jul 6, 2011
Registry last updated: Jul 6, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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