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

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这项研究是在美国多个中心进行的奥司他韦治疗确诊为流感感染的24个月以下儿童的前瞻性、年龄分层的药代动力学/药效学和安全性评估。这项研究将为这一人群提供更准确的剂量建议。 48至108名婴儿(住院和门诊)将被纳入五个年龄组中的一个。在研究开始时，第二组和第三组将同时入选。第四组和第五组将根据前一组的药代动力学和安全性数据，按年龄递减顺序登记。属于奥司他韦治疗市场适应症的年龄最大的队列(队列I)，可以在研究期间的任何时间进行登记。 参加第一组试验的受试者口服奥司他韦的剂量为30毫克，每天两次，连续服用5天，这是目前的推荐剂量。II-V组的受试者将接受3毫克/公斤/剂量(剂量不超过30毫克，2次/日)的口服，每天两次，连续五天。在开启第四组或第五组之前，可根据在前一组中达到目标奥司他韦AUC12范围所需的剂量来调整剂量。

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.