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
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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).
Studietyp
Kontakter och platser
Studieorter
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New South Wales
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Sydney, New South Wales, Australien, 2145
- Westmead Hospital
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Sydney, New South Wales, Australien, 2010
- St Vincent's Hospital
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Sydney, New South Wales, Australien, 2031
- Prince of Wales Hospital
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Queensland
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Brisbane, Queensland, Australien, 4000
- Royal Brisbane Hospital
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South Australia
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Adelaide, South Australia, Australien, 5000
- Royal Adelaide Hospital
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Adelaide, South Australia, Australien, 5000
- Flinders Medical Centre
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Victoria
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Melbourne, Victoria, Australien, 3004
- The Alfred Hospital
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Western Australia
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Perth, Western Australia, Australien, 6000
- Royal Perth Hospital
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Mortality
Tidsram: One month
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One month
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Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Dominic Dwyer, FRACP, FRCPA, MD, Westmead Hospital
Studieavstämningsdatum
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- PIPET A
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