A Study of Exclusion Criteria in a University Population

Influenza Clinical Trial

— eX-FLU  

Official title:

A Randomized Study of Exclusion Criteria in a University Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01472536
• Other study ID #: 1U01CK000185-01
• Status: Completed
• Phase: N/A
• First received: November 11, 2011
• Last updated: January 24, 2016
• Start date: November 2011
• Est. completion date: August 2013

Study information

• 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

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza

Intervention

Behavioral:
• Sequestration
Students will be sequestered within their residence hall room for 3 days following influenza like illness symptoms.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

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