- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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-
Michigan
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Ann Arbor, Michigan, Estados Unidos, 48109
- University of Michigan
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación factorial
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Sin intervención: Control
Sin intervención
|
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Laboratory confirmed cases of Influenza
Periodo de tiempo: 10 weeks
|
10 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Cases of influenza like illness
Periodo de tiempo: 10 weeks
|
10 weeks
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Arnold S Monto, MD, University of Michigan
- Investigador principal: Allison E Aiello, PhD, University of Michigan
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 1U01CK000185-01 (Subvención/contrato del NIH de EE. UU.)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .