Tolerability and Measurability of the Efficacy of Non Pharmaceutical Measures to Prevent Seasonal Influenza
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Secondary infection with influenza of the household members who are healthy at the start of the study
研究概览
简要总结
With this study the investigators will try to assess the tolerability and measurability of the efficacy of non pharmaceutical measures to prevent seasonal influenza in individual households. Households with an identified index case of influenza will be randomised into one of three intervention arms: 1. group, where the household will receive general information about transmission of influenza virus and means to prevent it (Controls); 2. group, which will receive surgical masks and be asked to wear them whenever they are in close contact with the index case or other persons of the household that became ill during the observation period; 3. group, which will be given and asked to wear surgical masks as well as to execute intensified hand hygiene.
In addition to assessing the secondary attack rate as our primary outcome measure, the investigators will also try to evaluate compliance to those interventions by questionnaires.
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
- None
入排标准
- 年龄范围
- 2 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •influenza like illness symptoms
- •positive rapid test for influenza
- •inclusion within 48h of symptom onset
- •inclusion of at least 3 members of a household (including index case)
排除标准
- •severe illness
- •other cases of similar symptoms within 14 days before onset of symptoms in index patient
- •severe asthma or COPD
- •pregnancy of index
结局指标
主要结局
Secondary infection with influenza of the household members who are healthy at the start of the study
次要结局
未报告次要终点
