ChiCTR-IOR-15006823尚未招募不适用
奧司他韋(「特敏福」)在患上嚴重流行性感冒病人的藥效學及藥力學
Health and Medical Research Fund (Project reference no: CUHK-Portfolio-A13) of Food and Health Bureau of the Hong Kong Special Administrative Region Government1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 1990年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- rate of viral clearance over the period of treatment defined as the rate of PCR negativity (i.e. below detection limits) and culture negativity at each of the specimen sites (upper and lower respiratory tract) 5 days after commencement of treatment protocol.
研究概览
简要总结
奧司他韋(「特敏福」)在患上嚴重流行性感冒病人的藥效學及藥力學
研究设计
- 研究类型
- 干预性研究
- 主要目的
- 随机平行对照
- 盲法
- Single
入排标准
- 年龄范围
- 18 至 —（—）
- 性别
- All
入选标准
- •Adult patients suffering from influenza requiring mechanical ventilation who require oseltamivir therapy
排除标准
- •Pregnant patients and patients with renal failure requiring renal replacement therapy at presentation
研究组 & 干预措施
Two groups
Oseltamivir 150mg twice daily compared with Oseltamivir 225mg twice daily for minimum duration of 10 days
结局指标
主要结局
rate of viral clearance over the period of treatment defined as the rate of PCR negativity (i.e. below detection limits) and culture negativity at each of the specimen sites (upper and lower respiratory tract) 5 days after commencement of treatment protocol.
次要结局
- longitudinal viral concentration change in the upper respiratory tract (nasopharyngeal and tracheal samples) from day 0 to day 7 and from lower respiratory tract (BAL samples) between day 3 to day 5 and day 8 to day 10 of oseltamivir treatment.
- serial change of respiratory physiological and mechanical parameters (including but not limited to oxygen requirement, lung compliance, Positive End Expiratory Pressure (PEEP) requirement, radiological involvement, and composite severity score),
- duration of mechanical ventilator support
- ICU length of stay
- hospital length of stay
- 30 days mortality
研究者
研究点 (1)
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