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临床试验/NCT01472536
NCT01472536已完成不适用

A Randomized Study of Exclusion Criteria in a University Population

University of Michigan2 个研究点 分布在 1 个国家目标入组 1,400 人开始时间: 2011年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,400
试验地点
2
主要终点
Laboratory confirmed cases of Influenza

研究概览

简要总结

Much of community transmission of seasonal and pandemic influenza occurs in younger individuals, because of their susceptibility and their social interaction patterns.Universities are places where transmission of influenza is facilitated because of the age of individuals involved, their close contact with each other, and low vaccination coverage. Staying home when you are sick (i.e., voluntary sequestration) has been identified as one of the most efficient ways to reduce influenza transmission, but there are still insufficient data on the effects of social distancing to be able to make recommendations for future pandemics or even outbreaks of seasonal influenza.

The investigators are conducting a study on the effect of voluntary sequestration during illness on the transmission of influenza among social networks in University residence housing units at the University of Michigan. The sequestration interventions will be carried out during a period of influenza transmission that is defined by surveillance conducted at the University Health Service. Data will be collected on use of the interventions and the occurrence of influenza and other illnesses. In all selected residence halls, specimens will be collected when illness meeting a case definition for influenza-like illness occurs.

This study in a university population will evaluate the acceptability and magnitude of effect that can be expected from such an intervention, and determine the number of days that sequestration should be practiced.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Live in a participating residence hall at the time of enrollment
  • Be at least 18 years of age
  • Be willing to report social habits and illness information electronically on a weekly basis
  • Be willing to have a throat swab specimen collected if you have signs of illness during the influenza season
  • Be willing to nominate close social contacts living in eligible residence halls for participation in the study
  • Be willing to participate in a 3-day sequestration protocol as randomly assigned.

排除标准

  • Non-residence in selected Residence Halls
  • Unwillingness to participate in voluntary sequestration protocol and complete online surveys
  • Already study employee

结局指标

主要结局

Laboratory confirmed cases of Influenza

时间窗: 10 weeks

次要结局

  • Cases of influenza like illness(10 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Allison Aiello

Associate Professor, Epidemiology

University of Michigan

研究点 (2)

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