A Prospective Study to Examine the Effectiveness and Safety of Neuraminidase Inhibitors in Volunteers Who Receive Long-term Prophylaxis Against Pandemic Influenza: PIPET B
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 8
- 主要终点
- The primary measure used in this study will be the incidence of symptomatic pandemic influenza in patients receiving prophylaxis.
研究概览
简要总结
This aim of this project is to evaluate the efficacy of neuraminidase inhibitors as prophylaxis against pandemic influenza infection in patients who are prescribed a long term course in the context of a place of employment or profession. The study is observational only. The primary measure used in this study will be the incidence of symptomatic pandemic influenza in patients receiving prophylaxis. Seroconversion to pandemic influenza, the incidence of adverse events and the relative effectiveness of oseltamivir and zanamivir prophylaxis will also be examined. This project will commence upon pandemic influenza being declared in Australia, Hong Kong or Singapore. Data will be analysed as quickly as possible to help inform the continued use of neuraminidase inhibitor therapy as a cornerstone of the public health agency response to pandemic influenza.
详细描述
The aim of this study is to
- Describe the incidence of symptomatic pandemic influenza infection in participants receiving neuraminidase inhibitor prophylaxis in the context of a place of employment or a profession
- Describe the incidence of seroconversion to pandemic influenza
- Describe the incidence of adverse events in volunteers taking long term antiviral prophylaxis
- Compare the effectiveness of oseltamivir and zanamivir prophylaxis
The study is an open label prospective cohort study. Participants in this study will be health care and other essential workers receiving long term neuraminidase inhibitor prophylaxis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of written informed consent
- •Intention to commence, or already commenced prophylaxis with a neuraminidase inhibitor in the context of a place of employment or profession
- •It is anticipated that participants in this study who are subsequently clinically diagnosed with pandemic influenza will be enrolled in the Index Case protocol (PIPET-A) with follow-up as specified.
排除标准
- 未提供
结局指标
主要结局
The primary measure used in this study will be the incidence of symptomatic pandemic influenza in patients receiving prophylaxis.
时间窗: One month
次要结局
- Seroconversion to pandemic influenza, the incidence of adverse events and the relative effectiveness of oseltamivir and zanamivir prophylaxis will also be examined.(One month)