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SPRINT-SARI

ANZICS CTG Supported Study

SPRINT-SARI

Short period incidence study of severe acute respiratory infection

Study 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 (1-3). 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 (4-7). 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 (8, 9). Due to the severity and communicable nature of SARI – as demonstrated though the 2009 H1N1 pandemic, compounded with annual incidence of SARI during seasonal influenza epidemics – it is clear that investigation of SARI can provide large scale benefits to improve public health. Rapidly obtaining accurate information on the epidemiology of SARI and providing information on how these patients are currently diagnosed and treated is essential. 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.

Management Committee

Alexandre Demoule; Alistair Nichol; Allen Cheng; Behzad Nadjm; Beth Riviello; Calum Semple; Colin McArthur; Daniele Poole; David Paterson; Dean Everett; Djillali Annane; Evangelos Giamarellos-Bourboulis; Fernando Bozza; Flavia Riberiro Machado; Florence Komurian-Pradel; Gail Carson; Genevieve O’Neill; J. Perren Cobb; Jake Dunning; Jean-Daniel Chiche

Jin-Won Huh; John Marshall; Jordi Rello; Juilett Otieno; Julia Guillebaud; Norosoa Razanazatovo; Karen Green; Kathryn Maitland; Kathy Rowan; Kenneth Bailllie

Laura Merson; Li Yang Hsu; Michael Christian; Miia Valkonen

Moritoki Egi; Nahoko Shindo; Peter Horby; Rachael Parke

Raul Pardinaz-Solis; Rob Fowler; Sebastián Ugarte Ubiergo

Srinivas Murthy; Steven Webb; Tim Uyeki; Toni Gordan; Yaseen Arabi; and Zhancheng Gao

Administering Institution

ANZIC Research Centre, Monash University

Collaborators

International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC)
The Platform for European Preparedness Against (Re-)emerging Epidemics (PREPARE)
The International Forum for Acute Care Trialists (InFACT)
European Society of Intensive Care Medicine.

Participating Research Networks:

Asian Critical Care Trials Group;  Australian and New Zealand Intensive Care Society Critical Trials Group; Australian Society for Infectious Diseases Clinical Research Network; Brazilian Research in Intensive Care Network; Centers for Disease Control and prevention; the Community-Acquired Pneumonia in Unidad de Cuidados Intensivos 3; Canadian Critical Care Trials Group; European Society of Intensive Care Medicine; The Influenza Complications Alert Network (FluCAN); Global Approach to Biology in Response to Infectious Epidemics in Low-income Countries; Gruppo italiano per la Valutazione degli interventi in Terapia; Hellenic Sepsis Study Group; Irish Critical Care Trials Group; Intensive Care National Audit and Research Centre; Intensive Care Society; Institut Pasteur; KEMRI Clinical Trials Facility/Emergency Care Research Group; The Mexican Emerging Infectious Diseases Clinical Research Network; Latin American Critical  Care Trials Investigators’ Network; North African Network for ICM Research; Oxford University Clinical Research Unit; Research Network on Respiratory Failure and Artificial Ventilation; Scandinavian Critical Care Trials Group; Sino-International Severe Community-Acquired Pneumonia Consortium; Singapore Infectious Diseases Network; The Toronto Invasive Bacterial Diseases Network; TRIal Group for Global Evaluation and Research in Sepsis uk; United States Critical Illness and Injury Trials Group Program for Emergency Preparedness; and world Health Organisation

Project Status as of June 2019

The SPRINT-SARI study is currently undergoing a change in management as we re-work it into SPRINT-SARI 2.0. For long-term sustainability of this study, it will be moving to the University of Oxford (managed by ISARIC). SPRINT-SARI’s data server (REDCap currently managed at Monash University) has been successfully transferred to the University of Oxford, managed by ISARIC. The Chief Investigator has been changed from Professor Steven Webb (Monash University, Australia) to Dr Srinivas Murthy (University of British Columbia, Canada). Ethics Approval has been sought for this project amendment and current (and new sites) will now sign up to the Oxford data server in order to start data collection.

SPRINT-SARI 2.0 is currently underway with a focus on ICU registry integration with the study in countries with the appropriate infrastructure, starting with Australia and New Zealand Intensive Care Registry. Discussions are currently underway on what are the key data parameters which need to be collected. For pandemic severity assessments, the goal will be to determine the optimal metric for communicating the seriousness of potential outbreaks, i.e. to determine the optimal severity-of-illness metric for ill patients that can inform pandemic severity assessment programs.  The aim would also be to pilot data collection at selected SPRINT-SARI sites, and to create a reporting infrastructure. In order to assess inter-pandemic epidemiology, an accurate representation of the denominator of patients affected is crucial. For this, we aim to determine optimal strategies for participating sites to collect annual, aggregated SARI incidence data within their ICU, acknowledging that diverse strategies will be ultimately be needed for diverse settings; and to create and disseminate a site-level CRF to more accurately capture ICU and hospital capacities, as well as relevant populations served.

Reference

CTG1516-01
NCT02498587 (https://clinicaltrials.gov/ct2/show/NCT02498587)

Contact

Steve Webb (email)