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

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ClinicalTrials.gov Identifier: NCT01472536
Recruitment Status : Completed
First Posted : November 16, 2011
Last Update Posted : January 26, 2016
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Allison Aiello, University of Michigan

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Influenza Behavioral: Sequestration Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1400 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized Study of Exclusion Criteria in a University Population
Study Start Date : November 2011
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arms and Interventions
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Arm Intervention/treatment
Experimental: 3-day sequestration
Students will be sequestered within their residence hall room for 3 days following influenza like illness symptoms
 Behavioral: Sequestration
Students will be sequestered within their residence hall room for 3 days following influenza like illness symptoms.
No Intervention: Control
No intervention


Outcome Measures
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Primary Outcome Measures :
  1. Laboratory confirmed cases of Influenza [ Time Frame: 10 weeks ]

Secondary Outcome Measures :
  1. Cases of influenza like illness [ Time Frame: 10 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01472536


Locations
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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Centers for Disease Control and Prevention
Investigators
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Principal Investigator: Allison E Aiello, PhD University of Michigan
Principal Investigator: Arnold S Monto, MD University of Michigan
More Information
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Responsible Party: Allison Aiello, Associate Professor, Epidemiology, University of Michigan
ClinicalTrials.gov Identifier: NCT01472536    
Other Study ID Numbers: 1U01CK000185-01 ( U.S. NIH Grant/Contract )
First Posted: November 16, 2011    Key Record Dates
Last Update Posted: January 26, 2016
Last Verified: January 2016
Keywords provided by Allison Aiello, University of Michigan:
Influenza
Non pharmaceutical intervention
Sequestration
Social network
Additional relevant MeSH terms:
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Influenza, Human
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
 RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases