NCT00412555已完成4 期
An Open-label Multi-center Trial of Oseltamivir for the Seasonal Prophylaxis of Influenza in Children.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 52
- 主要终点
- AEs, laboratory parameters, vital signs.
研究概览
简要总结
This study will evaluate the safety of Tamiflu, when used for the prevention of influenza in children during the flu season. Children who would benefit from influenza prophylaxis when influenza is circulating in the community will receive treatment with Tamiflu syrup (or capsules) 30mg-75mg once daily (dependent on body weight) for 6 weeks. Safety data and influenza symptoms will be recorded throughout the study. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •males or females, 1-12 years of age;
- •candidate for seasonal prophylaxis;
- •negative rapid diagnostic test for influenza at baseline.
排除标准
- •symptoms suggestive of influenza-like illness;
- •positive rapid diagnostic test for influenza;
- •antiviral treatment for influenza in 2 weeks prior to randomization.
研究组 & 干预措施
1
Experimental
干预措施: oseltamivir [Tamiflu] (Drug)
结局指标
主要结局
AEs, laboratory parameters, vital signs.
时间窗: Throughout study
Percentage of patients with laboratory confirmed clinical influenza
时间窗: Throughout study
次要结局
- Percentage of subjects with asymptomatic influenza; percentage with an influenza-like illness.(Throughout study)
研究者
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