Pharmacokinetics of Oseltamivir in Newborns and Infants

Completed

• Conditions: Prematurity of Fetus
• Interventions: Drug: Oseltamivir

• Registration Number: NCT01388439
• Lead Sponsor: St. Louis Children's Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2011-06
• Study First Submitted: 2011-06-24
• Study First Submitted QC: 2011-07-05
• Last Update Submitted: 2011-07-05
• Study First Posted: 2011-07-06
• Last Update Posted: 2011-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Oseltamivir exposure	Oseltamivir	One infant in the Neonatal Intensive Care Unit (NICU) at St. Louis Children's Hospital experienced respiratory decompensation and tested positive for influenza virus type A by fluorescent antibody stain performed on a nasopharyngeal swab. This infant received treatment doses of oseltamivir. Subsequently, 27 other infants received oseltamivir prophylaxis for exposure to influenza virus type A. Exposed infants were those who shared a primary medical team, nursing care, respiratory therapist, physical therapist, or occupational therapist with the influenza A positive infant. Prophylaxis was deemed necessary by the attending neonatologist after consultation with the Infectious Diseases Division of the Department of Pediatrics at the Washington University School of Medicine.

Primary Outcome Measures

Name	Time	Method
Oseltamivir pharmacokinetics in neonates and infants	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 Outcome Measures

Name	Time	Method
Oseltamivir target level attainment	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.

Trial Locations

Locations (1)

St. Louis Children's Hosptial; 🇺🇸 St. Louis, Missouri, United States