Influenza Clinical Trial
— eX-FLUOfficial title:
A Randomized Study of Exclusion Criteria in a University Population
Verified date | January 2016 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1400 |
Est. completion date | August 2013 |
Est. primary completion date | August 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan | Centers for Disease Control and Prevention |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Laboratory confirmed cases of Influenza | 10 weeks | No | |
Secondary | Cases of influenza like illness | 10 weeks | No |
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