Short Period Incidence Study of Severe Acute Respiratory Illness

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorAustralian and New Zealand Intensive Care Research Centre

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Number of participating sites

The number of sites able to participate and submit data for central analysis

Time frame
one week
2

Data Completeness

The completeness of submitted data

Time frame
90 days
3

Barriers to data submission

Survey post SPRINT-SARI study period on barriers to data completion

Time frame
90 days

Secondary outcomes

1

Incidence of SARI

Number of participants during the study period at all sites

Time frame
one week
2

Length of Hospital Stay

Length of stay of SARI patients by co-morbidities and risk factors

Time frame
90 days
3

Symptoms at admission

Impact of different SARI case definitions on cohort

Time frame
90 days
4

Incidence of Intensive Care Unit Admission

Rate of ICU admission in SARI cohorts and international variation

Time frame
90 days

Other outcomes

1

Global Ethical Approval requirements

Survey post SPRINT-SARI study period of ethical approval requirements in participating countries

Time frame
90 days
2

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

Time frame
90 days

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