InfluenzaeX-FLUNCT01472536
A Study of Exclusion Criteria in a University Population
A study testing Sequestration in people with Influenza, run by University of Michigan at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Sequestration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,400 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Non-residence in selected Residence Halls
- Unwillingness to participate in voluntary sequestration protocol and complete online surveys
- Already study employee
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Study of Exclusion Criteria in a University Population
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.
- Conditions
- Influenza
- Being tested
- Sequestration
- Keywords
- Influenza, Non pharmaceutical intervention, Sequestration, Social network
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SequestrationBehavioural
Students will be sequestered within their residence hall room for 3 days following influenza like illness symptoms.
| Study group | Role | What they receive |
|---|---|---|
| 3-day sequestration | Experimental | Students will be sequestered within their residence hall room for 3 days following influenza like illness symptoms Receives: Behavioral: Sequestration |
| Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laboratory confirmed cases of Influenza
Measured: 10 weeks
Secondary outcomes (1)
Cases of influenza like illness
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Allison Aiello, University of Michigan
- Investigators
- Allison E Aiello, PhD, Principal investigator, University of MichiganArnold S Monto, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01472536
- Sponsor's protocol ID
- 1U01CK000185-01
- Acronym
- eX-FLU
- Status last verified
- Jan 2016
- First submitted
- 11 Nov 2011
- Last updated
- 26 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of Exclusion Criteria in a University Population
- ClinicalTrials.gov ID
- NCT01472536
- Acronym / sponsor ID
- eX-FLU / 1U01CK000185-01
- Conditions
- Influenza
- Keywords
- Influenza, Non pharmaceutical intervention, Sequestration, Social network
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,400 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Nov 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 16 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3-day sequestration | Experimental | Behavioral: SequestrationStudents will be sequestered within their residence hall room for 3 days following influenza like illness symptoms |
| Control | No intervention | –No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Non-residence in selected Residence Halls
- Unwillingness to participate in voluntary sequestration protocol and complete online surveys
- Already study employee
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SequestrationStudents will be sequestered within their residence hall room for 3 days following influenza like illness symptoms. | Behavioural | 3-day sequestration |
Primary outcome
Laboratory confirmed cases of Influenza
Time frame: 10 weeks
1 secondary outcome
Cases of influenza like illness
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allison E Aiello, PhD principal investigator
University of Michigan
Arnold S Monto, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sequestration in people with Influenza, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Laboratory confirmed cases of Influenza (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2016.