- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01472536
A Study of Exclusion Criteria in a University Population (eX-FLU)
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.
Studieoversikt
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Michigan
-
Ann Arbor, Michigan, Forente stater, 48109
- University of Michigan
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Faktoriell oppgave
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Ingen inngripen: Styre
Ingen inngrep
|
|
Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Laboratory confirmed cases of Influenza
Tidsramme: 10 weeks
|
10 weeks
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Cases of influenza like illness
Tidsramme: 10 weeks
|
10 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Arnold S Monto, MD, University of Michigan
- Hovedetterforsker: Allison E Aiello, PhD, University of Michigan
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1U01CK000185-01 (U.S. NIH-stipend/kontrakt)
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