Short PeRiod IncideNce sTudy of Severe Acute Respiratory Infection

SPRINT-SARI is an international, multi-centre, prospective, short period incidence observational study of patients in participating hospitals and intensive care units (ICUs) with severe acute respiratory infection (SARI).

About SPRINT-SARI

Aim: The primary aim of this study is to establish 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.

Rationale: 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 (≥38°C) 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.

SPRINT-SARI Ethical, Administrative, Regulatory and Logistic barriers (EARL)  
This sub-study (SPRINT-SARI-EARL) aims to follow and describe the application of SPRINT–SARI for all applicable EARL approvals in each participating region / nation. We will describe the experience of the researcher submitting the applications and the differing responses received and timelines of the committees (i.e. ethics committees) to a single protocol used in SPRINT-SARI that may create barriers to the rapid deployment of future observational studies and clinical trials in the event of a pandemic.


Contact
: For further information about this study, please email the SPRINT-SARI Project Manager

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This study is supported by ISARIC, InFACT and PREPARE

Resources
Study Protocol
Expression of Interest letter for networks
Case Report Form
Frequently Asked Questions

Ethical Administrative Regulatory and Logistics (EARL) Protocol 
EARL Expression of Interest letter
IRB/Ethics Master Guide (i.e. a draft of an IRB/Ethics application for sites/networks to adapt to meet local requirements)