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
研究概览
地位
条件
详细说明
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).
研究类型
联系人和位置
学习地点
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New South Wales
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Sydney、New South Wales、澳大利亚、2145
- Westmead Hospital
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Sydney、New South Wales、澳大利亚、2010
- St Vincent's Hospital
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Sydney、New South Wales、澳大利亚、2031
- Prince of Wales Hospital
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Queensland
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Brisbane、Queensland、澳大利亚、4000
- Royal Brisbane Hospital
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South Australia
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Adelaide、South Australia、澳大利亚、5000
- Royal Adelaide Hospital
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Adelaide、South Australia、澳大利亚、5000
- Flinders Medical Centre
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Victoria
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Melbourne、Victoria、澳大利亚、3004
- The Alfred Hospital
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Western Australia
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Perth、Western Australia、澳大利亚、6000
- Royal Perth Hospital
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
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
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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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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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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Mortality
大体时间:One month
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One month
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合作者和调查者
调查人员
- 首席研究员:Dominic Dwyer, FRACP, FRCPA, MD、Westmead Hospital
研究记录日期
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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