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临床试验/NCT00410176
NCT00410176Unknown不适用

A Randomized, Controlled, Unblinded, Clinical Trial of the Acceptability and Efficacy of Non-Pharmaceutical Methods in Preventing Spread of Influenza Within the Family

Ministry of Health, Israel0 个研究点目标入组 400 人开始时间: 2007年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
400
主要终点
secondary infection of influenza within the family

研究概览

简要总结

The proposed study will evaluate whether the use of non-pharmaceutical methods, such as surgical masks, isolation of patients and personal hygiene, are acceptable and effective in preventing the spread of influenza within the family.This will be achieved by conducting a randomized, controlled, unblinded, clinical trial. Family members of an index case with influenza like illness, will be randomly allocated to two groups. In the intervention group, family members will receive comprehensive guidance about sanitation and hygiene, as well as surgical masks to wear whenever in close contact (3 feet / 1 meter) with the index case. In addition, they will be asked to isolate the index case as much as possible. In the control group, family members will receive only standard guidance about sanitation and hygiene relevant for reducing the transmission of influenza. The primary end-point of the study will be secondary infection of influenza of at least one of the family members in order to asses the efficacy of the interventions. In addition, the compliance to those interventions will be evaluated.

The study hypothesis is that use of non-pharmaceutical methods will be acceptable and will reduce the secondary infection rate among them by 50%.

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

性别
All
接受健康志愿者

入选标准

  • Family members of an index case with influenza-like illness (ILI) during the first two days of his illness.
  • No limitations will be given regarding the number of family members.

排除标准

  • Presence of another household member with ILI during the previous two weeks.

结局指标

主要结局

secondary infection of influenza within the family

次要结局

  • compliance of non-pharmaceutical interventions

研究者

发起方
Ministry of Health, Israel
申办方类型
Other Gov

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