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
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1400 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
Experimental: 3-day sequestration
Students will be sequestered within their residence hall room for 3 days following influenza like illness symptoms
Students will be sequestered within their residence hall room for 3 days following influenza like illness symptoms.
No Intervention: Control
- Laboratory confirmed cases of Influenza [ Time Frame: 10 weeks ]
- Cases of influenza like illness [ Time Frame: 10 weeks ]
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
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Allison E Aiello, PhD||University of Michigan|
|Principal Investigator:||Arnold S Monto, MD||University of Michigan|