Short Period Incidence Study of Severe Acute Respiratory Illness

Study Overview
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Brief Summary
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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
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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.

Official Title
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Short Period Incidence Study of Severe Acute Respiratory Illness

Conditions
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Severe Acute Respiratory Infection

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A history of feverishness or measured fever of ≥ 38 deg C; Cough; Dyspnoea (shortness of breath) OR Tachypnoea. Exclusion Criteria: • No exclusion criteria
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participating sites | The number of sites able to participate and submit data for central analysis | one week | 
| Data Completeness | The completeness of submitted data | 90 days | 
| Barriers to data submission | Survey post SPRINT-SARI study period on barriers to data completion | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of SARI | Number of participants during the study period at all sites | one week | 
| Length of Hospital Stay | Length of stay of SARI patients by co-morbidities and risk factors | 90 days | 
| Symptoms at admission | Impact of different SARI case definitions on cohort | 90 days | 
| Incidence of Intensive Care Unit Admission | Rate of ICU admission in SARI cohorts and international variation | 90 days | 
| Length of Intensive Care Unit Admission | Length of stay for participants admitted to an ICU during SARI hospital admission | 90 days | 
| SARI Microbiology | Microbiological SARI diagnosis of participants (if known) during hospital admission | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Severe Acute Respiratory Infection