Short Period Incidence Study of Severe Acute Respiratory Illness

NCT ID: NCT02498587

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 15000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2026-12-31

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.

Conditions

Severe Acute Respiratory Infection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• A history of feverishness or measured fever of ≥ 38 deg C;
• Cough;
• Dyspnoea (shortness of breath) OR Tachypnoea.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

International Severe Acute Respiratory and Emerging Infection Consortium

OTHER

Sponsor Role: collaborator

The International Forum of Acute Care Trialists

UNKNOWN

Sponsor Role: collaborator

Australian and New Zealand Intensive Care Research Centre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Australian and New Zealand Intensive Care Research Centre

Melbourne, Victoria, Australia

Site Status: RECRUITING

Countries

Australia

Central Contacts

Nicole Ng, MBBS

Role: CONTACT

mnhs-sprint.sari@monash.edu

Facility Contacts

Nicole Ng, MBBS

Role: primary

mnhs-sprint.sari@monash.edu

Tony Trapani

Role: backup

tony.trapani@monash.edu

Other Identifiers

ANZIC-RC/SW0002

Identifier Type: -

Identifier Source: org_study_id