Short Period Incidence Study of Severe Acute Respiratory Illness
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Severe Acute Respiratory Infection
- Sponsor
- Australian and New Zealand Intensive Care Research Centre
- Enrollment
- 15000
- Locations
- 1
- Primary Endpoint
- Barriers to data submission
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •A history of feverishness or measured fever of ≥ 38 deg C;
- •Dyspnoea (shortness of breath) OR Tachypnoea.
Exclusion Criteria
- •No exclusion criteria
Outcomes
Primary Outcomes
Barriers to data submission
Time Frame: 90 days
Survey post SPRINT-SARI study period on barriers to data completion
Number of participating sites
Time Frame: one week
The number of sites able to participate and submit data for central analysis
Data Completeness
Time Frame: 90 days
The completeness of submitted data
Secondary Outcomes
- 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)