To Evaluate the Incidence of Acute Otitis Media in Children in Five East European Countries
24 de julio de 2014 actualizado por: GlaxoSmithKline
To Evaluate Incidence of Acute Otitis Media in Children Aged < 6 Years in Five East European Countries
The aim of this study is to provide baseline acute otitis media data in East European countries.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Each subject's involvement in this study will include a retrospective and prospective part.
Tipo de estudio
De observación
Inscripción (Actual)
2258
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Ljubljana, Eslovenia, 1000
- GSK Investigational Site
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Ljubljana, Eslovenia, 1210
- GSK Investigational Site
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Maribor, Eslovenia, 2000
- GSK Investigational Site
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Maribor, Eslovenia
- GSK Investigational Site
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Ptuj, Eslovenia, 2250
- GSK Investigational Site
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Ruše, Eslovenia, 2342
- GSK Investigational Site
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Tallinn, Estonia, 10621
- GSK Investigational Site
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Vilnius, Lituania, LT-07156
- GSK Investigational Site
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Vilnius, Lituania, LT-04318
- GSK Investigational Site
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Vilnius, Lituania, LT-03147
- GSK Investigational Site
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Bydgoszcz, Polonia, 85-796
- GSK Investigational Site
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Debica, Polonia, 39-200
- GSK Investigational Site
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Katowice, Polonia, 40-018
- GSK Investigational Site
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Kielce, Polonia, 25-711
- GSK Investigational Site
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Leczna, Polonia, 21-010
- GSK Investigational Site
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Siemianowice Slaskie, Polonia, 41-103
- GSK Investigational Site
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Tarnow, Polonia, 33-100
- GSK Investigational Site
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Warszawa, Polonia, 01-809
- GSK Investigational Site
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Wejherowo, Polonia, 84-200
- GSK Investigational Site
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Wola, Polonia, 43-225
- GSK Investigational Site
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Bacau, Rumania, 600316
- GSK Investigational Site
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Brasov, Rumania, 500260
- GSK Investigational Site
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Bucharest, Rumania, 051821
- GSK Investigational Site
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Craiova, Rumania, 200128
- GSK Investigational Site
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Galati, Rumania, 800394
- GSK Investigational Site
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
No mayor que 6 años (Niño)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
Subjects aged < 6 years who are registered in primary care clinics of any of the participating countries (Estonia, Lithuania, Poland, Romania and Slovenia) will be enrolled in this study.
Descripción
Inclusion Criteria:
- Subjects who the investigator believes that parent(s)/ legally acceptable representative(s) can and will comply with the requirements of the protocol.
- A male or female subject aged < 6 years at the time of enrolment.
- The investigator has access to the medical records that contain the medical history of the subjects for one year prior to enrolment (for subjects aged 1 to < 6 years) or from birth (for subjects aged < 1 year).
- Written informed consent obtained from either both parents/ LARs or from one parent/ LAR of the subject with the declaration of cooperation for one year after enrolment.
Exclusion Criteria:
- Acute otitis media episode at the time of enrolment.
- Upper respiratory tract infection at the time of enrolment.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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Cohort A
Subjects aged < 6 years who are registered in primary care clinics of any of the participating countries (Estonia, Lithuania, Poland, Romania and Slovenia).
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For the retrospective part of the study, the parent(s)/ legally acceptable representative(s) of the subjects will be interviewed to collect information on factors potentially related to risk for middle ear diseases.
The medical records of the subjects will also be reviewed and all acute otitis media related problems that occurred during the last year prior to enrolment (for subjects aged 1 to < 6 years) or since birth (for subjects aged < 1 year) will be recorded in the electronic case report form.
For the prospective part of the study, the enrolled subjects will be followed up for a period of 1 year starting from the consent date, during which the parent(s)/ legally acceptable representative(s) will be asked to bring the subject for a visit each time they notice symptoms of acute otitis media or respiratory tract infection in the subject.
In case AOM is diagnosed by the investigator, detailed information on the signs, symptoms, severity, course and treatment will be recorded.
The parent(s)/ legally acceptable representative(s) of the subjects will also be required to fill up a parental quality of life questionnaire and an Otitis Media-6 children's quality of life questionnaire.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Occurrence of acute otitis media in subjects aged < 6 years as diagnosed by a family physician and documented in medical records - retrospective part of the study
Periodo de tiempo: Retrospective data for 12 months prior to study entry for subjects aged > 1 year or for the entire period since birth for subjects aged < 1 year
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Retrospective data for 12 months prior to study entry for subjects aged > 1 year or for the entire period since birth for subjects aged < 1 year
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Occurrence of acute otitis media in subjects aged < 6 years as diagnosed by the physician or specialist - prospective part of the study
Periodo de tiempo: Prospective data for 12 months after study entry
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Prospective data for 12 months after study entry
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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Prevalence of otitis media with effusion among acute otitis media cases aged < 6 years in the four consecutive seasons of the year
Periodo de tiempo: Prospective data for 12 months after study entry
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Prospective data for 12 months after study entry
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Occurrence of suspected acute otitis media as reported by the parent(s)/ legally acceptable representative(s) (and not diagnosed by any physician) during the bi-monthly follow-up
Periodo de tiempo: Prospective data for 12 months after study entry
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Prospective data for 12 months after study entry
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Occurrence of recurrent acute otitis media
Periodo de tiempo: Retrospective data for 12 months prior to study entry for subjects aged > 1 year or for the entire period since birth for subjects aged < 1 year and prospective data for 12 months after study entry
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Retrospective data for 12 months prior to study entry for subjects aged > 1 year or for the entire period since birth for subjects aged < 1 year and prospective data for 12 months after study entry
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Occurrence of acute otitis media treatment failures
Periodo de tiempo: Prospective data for 12 months after study entry
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Prospective data for 12 months after study entry
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Assessment of the impact of acute otitis media on the quality of life of the subject and family by the parental quality of life questionnaire and the Otitis Media-6 children's quality of life questionnaire
Periodo de tiempo: Prospective data for 12 months after study entry
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Prospective data for 12 months after study entry
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Direct medical, direct non-medical costs and indirect medical costs of one incident of acute otitis media
Periodo de tiempo: Prospective data for 12 months after study entry
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Prospective data for 12 months after study entry
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Occurrence of acute otitis media as diagnosed by the study physician or any other doctor
Periodo de tiempo: Prospective data for 12 months after study entry
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Prospective data for 12 months after study entry
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Use of antimicrobial therapy and other forms of treatment for acute otitis media, diagnostic procedures
Periodo de tiempo: Prospective data for 12 months after study entry
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Prospective data for 12 months after study entry
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de junio de 2011
Finalización primaria (Actual)
1 de diciembre de 2012
Finalización del estudio (Actual)
1 de diciembre de 2012
Fechas de registro del estudio
Enviado por primera vez
31 de mayo de 2011
Primero enviado que cumplió con los criterios de control de calidad
1 de junio de 2011
Publicado por primera vez (Estimar)
3 de junio de 2011
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
28 de julio de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
24 de julio de 2014
Última verificación
1 de mayo de 2014
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 115356
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