Severe Acute Respiratory Infection
Conditions
Keywords
Severe Acute Respiratory Infection
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.
Interventions
None listed
Sponsors
International Severe Acute Respiratory and Emerging Infection Consortium
The International Forum of Acute Care Trialists
Australian and New Zealand Intensive Care Research Centre
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* A history of feverishness or measured fever of ≥ 38 deg C; * Cough; * Dyspnoea (shortness of breath) OR Tachypnoea.
Exclusion criteria
• No
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Barriers to data submission | 90 days | Survey post SPRINT-SARI study period on barriers to data completion |
| Data Completeness | 90 days | The completeness of submitted data |
| Number of participating sites | one week | The number of sites able to participate and submit data for central analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptoms at admission | 90 days | Impact of different SARI case definitions on cohort |
| Length of Intensive Care Unit Admission | 90 days | Length of stay for participants admitted to an ICU during SARI hospital admission |
| SARI Microbiology | 90 days | Microbiological SARI diagnosis of participants (if known) during hospital admission |
| Incidence of Intensive Care Unit Admission | 90 days | Rate of ICU admission in SARI cohorts and international variation |
| Incidence of SARI | one week | Number of participants during the study period at all sites |
| Length of Hospital Stay | 90 days | Length of stay of SARI patients by co-morbidities and risk factors |
Other
| Measure | Time frame | Description |
|---|---|---|
| Global Ethical Approval requirements | 90 days | Survey post SPRINT-SARI study period of ethical approval requirements in participating countries |
| Time requirements for obtaining Ethical approval | 90 days | Survey post SPRINT-SARI study period of time required to obtain ethical approval for SPRINT-SARI at participating sites |
Countries
Australia
Contacts
Primary ContactNicole Ng, MBBS
Outcome results
None listed