Short Period Incidence Study of Severe Acute Respiratory Illness — SPRINT-SARI  

Severe Acute Respiratory Infection Clinical Trial

Official title: Short Period Incidence Study of Severe Acute Respiratory Illness

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Respiratory Tract Infections
• Severe Acute Respiratory Infection

• NCT number: NCT02498587
• Study type: Observational
• Source: Australian and New Zealand Intensive Care Research Centre
• Contact: Maya George, PhD
• Phone: 450974042
• Email: Maya.George@monash.edu
• Status: Recruiting
• Start date: January 2016
• Completion date: December 2024