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A Study of Exclusion Criteria in a University Population (eX-FLU)

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University of Michigan

Status

Completed

Conditions

Influenza

Treatments

Behavioral: Sequestration

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT01472536
1U01CK000185-01

Details and patient eligibility

About

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.

Enrollment

1,400 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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.

Exclusion criteria

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

1,400 participants in 2 patient groups

3-day sequestration
Experimental group
Description:
Students will be sequestered within their residence hall room for 3 days following influenza like illness symptoms
Treatment:
Behavioral: Sequestration
Control
No Intervention group
Description:
No intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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