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临床试验/NCT00833885
NCT00833885已完成不适用

Tolerability and Measurability of the Efficacy of Non Pharmaceutical Measures to Prevent Seasonal Influenza

Robert Koch Institut2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2009年1月1日最近更新:
适应症

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

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

研究者

发起方
Robert Koch Institut
申办方类型
Other Gov

研究点 (2)

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