A Prospective Study to Examine the Effectiveness and Safety of Neuraminidase Inhibitors in Index Cases With Presumed Pandemic Influenza (PIPET A)
A Prospective Study to Examine the Effectiveness and Safety of Neuraminidase Inhibitors in Index Cases With Presumed Pandemic Influenza Infection
Descripción general del estudio
Estado
Condiciones
Descripción detallada
The aim of this study is to describe treatment outcomes in patients infected with pandemic influenza (the most likely case being a version of the influenza A H5N1 virus) including overall survival, the incidence and duration of hospitalization, the resolution of protocol specified symptoms, the incidence and the severity of treatment limiting side effects in treated patients. This study will also describe the sequelae of influenza in infected patients including transmission to other persons, associations between baseline data and treatment outcomes and drug resistance. A repository of biological samples will also be created to examine virological and immunological concepts relating to pandemic influenza.
It is an open label prospective cohort study. Patients presenting at study sites with the recognised clinical case definition for pandemic influenza (to be distributed by State and Commonwealth Departments of Health when first clinical case occurs) will be eligible to be enrolled on the study. Informed consent to participate in the study will be sought including parental/guardian consent for minors and presumed consent for adults who are incapacitated (consistent with NHMRC requirements).
Tipo de estudio
Contactos y Ubicaciones
Ubicaciones de estudio
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New South Wales
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Sydney, New South Wales, Australia, 2145
- Westmead Hospital
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Sydney, New South Wales, Australia, 2010
- St Vincent's Hospital
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Sydney, New South Wales, Australia, 2031
- Prince of Wales Hospital
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Queensland
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Brisbane, Queensland, Australia, 4000
- Royal Brisbane Hospital
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South Australia
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Adelaide, South Australia, Australia, 5000
- Royal Adelaide Hospital
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Adelaide, South Australia, Australia, 5000
- Flinders Medical Centre
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Victoria
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Melbourne, Victoria, Australia, 3004
- The Alfred Hospital
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Western Australia
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Perth, Western Australia, Australia, 6000
- Royal Perth Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Clinical diagnosis of pandemic influenza (consistent with the applicable clinical case definition)
- Provision of written informed consent or equivalent
- Intention to commence treatment with a neuraminidase inhibitor
Exclusion Criteria:
- none
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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PIPET A
Patients presenting at study sites with the recognised clinical case definition for pandemic influenza (to be distributed by State and Commonwealth Departments of Health when first clinical case occurs) will be eligible to be enrolled on the study.
Informed consent to participate in the study will be sought including parental/guardian consent for minors and presumed consent for adults who are incapacitated (consistent with NHMRC requirements).
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Mortality
Periodo de tiempo: One month
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One month
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Dominic Dwyer, FRACP, FRCPA, MD, Westmead Hospital
Fechas de registro del estudio
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
- PIPET A
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