Short Period Incidence Study of Severe Acute Respiratory Illness
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15,000
- 试验地点
- 1
- 主要终点
- Barriers to data submission
研究概览
简要总结
This is a multi-centre, prospective, short period incidence observational study of patients in participating hospitals and intensive care units (ICUs) with SARI. The study period will occur, in both Northern and Southern hemispheric winters. The study period will comprise a 5 to 7-day cohort study in which patients meeting a SARI case-definition, who are newly admitted to the hospitals / ICUs at participating sites, will be included in the study. The study will be conducted in 20 to 40-hospital/ ICU-based research networks globally. All clinical information and sample data will only be recorded if taken as part of the routine clinical practice at each site and only fully anonymised and de-identified data will be submitted centrally.
The primary aim of this study is to establishing a research response capability for a future epidemic / pandemic through a global SARI observational study. The secondary aim of this study is to investigate the descriptive epidemiology and microbiology profiles of patients with SARI. The tertiary aim of this study is to assess the Ethics, Administrative, Regulatory and Logistic (EARL) barriers to conducting pandemic research on a global level.
详细描述
Severe acute respiratory infection (SARI) continues to be of major relevance to public health worldwide. In the last 10 years there have been multiple SARI outbreaks around the world. The 2009 H1N1 pandemic was estimated to result in more than 200,000 respiratory deaths globally. The World Health Organization (WHO) defines SARI as an acute respiratory infection of recent onset (within 10 days) requiring hospitalisation, manifested by fever (≥38oC) or a history of fever and cough. There is international consensus that it is important to undertake observational studies of patients with SARI as an essential component of pandemic and epidemic research preparedness.
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
- 否
入选标准
- •A history of feverishness or measured fever of ≥ 38 deg C;
- •Dyspnoea (shortness of breath) OR Tachypnoea.
排除标准
- •No exclusion criteria
结局指标
主要结局
Barriers to data submission
时间窗: 90 days
Survey post SPRINT-SARI study period on barriers to data completion
Number of participating sites
时间窗: one week
The number of sites able to participate and submit data for central analysis
Data Completeness
时间窗: 90 days
The completeness of submitted data
次要结局
- Incidence of Intensive Care Unit Admission(90 days)
- Incidence of SARI(one week)
- Length of Hospital Stay(90 days)
- Length of Intensive Care Unit Admission(90 days)
- SARI Microbiology(90 days)
- Symptoms at admission(90 days)