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

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目及 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者的研究机构。 这项研究是一项前瞻性、年龄分层的药代动力学/药效学和安全性评估，在美国多个中心对确诊流感感染的24个月以下儿童进行奥司他韦治疗。PK数据将为这一人群提供更精确的剂量建议。 48至108名婴儿（住院和门诊）将入组5个年龄组之一。 研究开始时，队列II和III将同时入组。根据前一队列的药代动力学和安全性数据，按年龄组降序入组队列IV和V。最早的队列（队列I），其福尔斯属于奥司他韦治疗的上市适应症，可在研究期间的任何时间入组。 入组队列I的受试者的奥司他韦剂量为30 mg，口服，每日两次，持续5天，这是目前推荐的剂量。队列II-V中的受试者将接受3 mg/kg/剂（剂量不超过30 mg bid）口服给药，每日两次，持续5天。 在开放队列IV或V之前，可根据前一队列中达到目标奥司他韦羧酸盐AUC 12范围所需的剂量调整剂量。

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.