NCT00593502已完成4 期
A Double-Blind, Randomized, Placebo-Controlled Study of Early Oseltamivir Treatment of Influenza in Children 1-3 Years of Age
Hospital District of Southwestern Finland1 个研究点 分布在 1 个国家目标入组 409 人开始时间: 2008年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 409
- 试验地点
- 1
- 主要终点
- Percentage of influenza-infected children in whom acute otitis media develops after the start of study medication
研究概览
简要总结
The main purpose of this study is to assess the efficacy of early oseltamivir treatment (started within 24 hours of the onset of influenza symptoms) in preventing the development of acute otitis media as a complication of influenza in children aged 1-3 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 1-3 years
- •Fever = or > 38.0 C and at least one respiratory symptom OR fever = or > 38.0 C and a positive influenza rapid test
排除标准
- •Confirmed infection with any other respiratory virus than influenza.
- •Suspicion of invasive bacterial infection requiring immediate admission to hospital
- •Evidence of a poorly controlled underlying medical condition
- •Known immunosuppression (malignancy, transplant, drugs)
- •Known allergy to oseltamivir or paracetamol
- •Received oseltamivir within 4 weeks
- •Participation in another clinical trial with an investigational drug
研究组 & 干预措施
1
Active Comparator
Oseltamivir
干预措施: oseltamivir (Drug)
2
Placebo Comparator
Placebo
干预措施: placebo (Drug)
结局指标
主要结局
Percentage of influenza-infected children in whom acute otitis media develops after the start of study medication
时间窗: 1-8 days
次要结局
- Time to resolution of fever and other clinical symptoms(1-21 days)
研究者
研究点 (1)
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