Short Period Incidence Study of Severe Acute Respiratory Illness

Recruiting

• Conditions: Severe Acute Respiratory Infection

• Registration Number: NCT02498587
• Lead Sponsor: Australian and New Zealand Intensive Care Research Centre

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.

Study Timeline

• Study First Submitted: 2015-03-26
• Study First Submitted QC: 2015-07-13
• Study First Posted: 2015-07-15
• Study Start: 2016-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-07
• Last Update Posted: 2024-08-09
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
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
Symptoms at admission	90 days	Impact of different SARI case definitions on cohort

Trial Locations

Locations (1)

Australian and New Zealand Intensive Care Research Centre; 🇦🇺 Melbourne, Victoria, Australia