A PHARMACOKINETIC/PHARMACODYNAMIC AND SAFETY EVALUATION OF OSELTAMIVIR (TAMIFLU)

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This study is a prospective, age-stratified pharmacokinetic/pharmacodynamic and safety evaluation of oseltamivir therapy in children less than 24 months of age with confirmed influenza infection, conducted in multiple centers across the U.S. PK data will lead to a more precise dosing recommendation for this population. Between 48 and 108 infants (hospitalized and outpatient) will be enrolled into one of five age cohorts. At study onset, Cohort II and III will be enrolled simultaneously. Cohorts IV and V will be enrolled sequentially by decreasing age groups, predicated upon the pharmacokinetic and safety data from the preceding cohort. The oldest cohort (Cohort I), which falls under the marketed indication for oseltamivir treatment, may be enrolled at any time during the study. Dosing of oseltamivir for subjects enrolling in Cohort I will be 30 mg orally twice daily for 5 days which is the current recommended dose. Subjects in Cohorts II-V will receive 3 mg/kg/dose (dose not to exceed 30mg bid) administered orally twice daily for five days. The dose may be adjusted prior to opening Cohort IV or V based on the dose required to achieve the target oseltamivir carboxylate AUC12 range in the previous cohort.