About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
A history of feverishness or measured fever of ≥ 38 deg C;
Cough;
Dyspnoea (shortness of breath) OR Tachypnoea.
Disqualifiers
None
Trial population
All patients newly admitted to participating hospitals, of any age, presenting with SARI during the study period. Patients will be eligible for the study if the patient meets the case definition for SARI. A suspected or proven acute respiratory infection requiring new inpatient admission with onset within the past 14 days. With one or more of the inclusion criteria.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Number of participating sites
The number of sites able to participate and submit data for central analysis
Data Completeness
The completeness of submitted data
Barriers to data submission
Survey post SPRINT-SARI study period on barriers to data completion
Secondary outcomes
Incidence of SARI
Number of participants during the study period at all sites
Length of Hospital Stay
Length of stay of SARI patients by co-morbidities and risk factors
Symptoms at admission
Impact of different SARI case definitions on cohort
Incidence of Intensive Care Unit Admission
Rate of ICU admission in SARI cohorts and international variation
Other outcomes
Global Ethical Approval requirements
Survey post SPRINT-SARI study period of ethical approval requirements in participating countries
Time requirements for obtaining Ethical approval
Survey post SPRINT-SARI study period of time required to obtain ethical approval for SPRINT-SARI at participating sites
Sponsors and contacts
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Australian and New Zealand Intensive Care Research Centre
Lead sponsor
International Severe Acute Respiratory and Emerging Infection Consortium
Collaborator
The International Forum of Acute Care Trialists
Collaborator