A Study of Exclusion Criteria in a University Population (eX-FLU)
Primary Purpose
Influenza
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sequestration
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring Influenza, Non pharmaceutical intervention, Sequestration, Social network
Eligibility 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
Sites / Locations
- University of Michigan
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
3-day sequestration
Control
Arm Description
Students will be sequestered within their residence hall room for 3 days following influenza like illness symptoms
No intervention
Outcomes
Primary Outcome Measures
Laboratory confirmed cases of Influenza
Secondary Outcome Measures
Cases of influenza like illness
Full Information
NCT ID
NCT01472536
First Posted
November 11, 2011
Last Updated
January 24, 2016
Sponsor
University of Michigan
Collaborators
Centers for Disease Control and Prevention
1. Study Identification
Unique Protocol Identification Number
NCT01472536
Brief Title
A Study of Exclusion Criteria in a University Population
Acronym
eX-FLU
Official Title
A Randomized Study of Exclusion Criteria in a University Population
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Centers for Disease Control and Prevention
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza, Non pharmaceutical intervention, Sequestration, Social network
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1400 (Actual)
8. Arms, Groups, and Interventions
Arm Title
3-day sequestration
Arm Type
Experimental
Arm Description
Students will be sequestered within their residence hall room for 3 days following influenza like illness symptoms
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Behavioral
Intervention Name(s)
Sequestration
Intervention Description
Students will be sequestered within their residence hall room for 3 days following influenza like illness symptoms.
Primary Outcome Measure Information:
Title
Laboratory confirmed cases of Influenza
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Cases of influenza like illness
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allison E Aiello, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Arnold S Monto, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of Exclusion Criteria in a University Population
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