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

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.

Study Overview

• Status: Recruiting
• Conditions: Severe Acute Respiratory Infection

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 Type: Observational
• Enrollment (Estimated): 15000

Contacts and Locations

• Study Contact: Name: Nicole Ng, MBBS; Email: mnhs-sprint.sari@monash.edu

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Recruiting
      • Australian and New Zealand Intensive Care Research Centre
      • Principal Investigator: Alexandre Demoule
      • Principal Investigator: Colin McArthur
      • Contact: Nicole Ng, MBBS; Email: mnhs-sprint.sari@monash.edu
      • Contact: Tony Trapani; Email: tony.trapani@monash.edu
      • Principal Investigator: Steven Webb
      • Principal Investigator: J.Perren Cobb
      • Principal Investigator: Rob Fowler
      • Principal Investigator: Srinivas Murthy
      • Principal Investigator: Alistair Nichol
      • Principal Investigator: Rachael Parke
      • Principal Investigator: Eoin West
      • Principal Investigator: Woni-il Choi
      • Principal Investigator: Calum Semple
      • Principal Investigator: Beth Riviello
      • Principal Investigator: Florence Pradel
      • Principal Investigator: Julia Guillebaud
      • Principal Investigator: Behzad Nadjm
      • Principal Investigator: Evangelos Giamerellos
      • Principal Investigator: Mia Valkonein
      • Principal Investigator: Annane Djillali
      • Principal Investigator: Santiago Perez
      • Principal Investigator: Allen Cheng
      • Principal Investigator: Daniele Poole
      • Principal Investigator: Dean Everett
      • Principal Investigator: Djillali ANNANE
      • Principal Investigator: Gail Carson
      • Principal Investigator: Jake Dunning
      • Principal Investigator: Jordi Rello
      • Principal Investigator: Juilett Otieno
      • Principal Investigator: Karen Green
      • Principal Investigator: Kathryn Maitland
      • Principal Investigator: Kathy Rowan
      • Principal Investigator: Kenneth Bailllie
      • Principal Investigator: Michael Christian
      • Principal Investigator: Tim Uyeki
      • Principal Investigator: Yaseen Arabi
      • Principal Investigator: T.Eoin West
      • Principal Investigator: Won-il Choi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients newly admitted to participating hospitals, of any age, presenting with SARI during the study period. Patients will be eligible for the study if the patient meets the case definition for SARI.

A suspected or proven acute respiratory infection requiring new inpatient admission with onset within the past 14 days. With one or more of the inclusion criteria.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of SARI	Number of participants during the study period at all sites	one week
Length of Hospital Stay	Length of stay of SARI patients by co-morbidities and risk factors	90 days
Symptoms at admission	Impact of different SARI case definitions on cohort	90 days
Incidence of Intensive Care Unit Admission	Rate of ICU admission in SARI cohorts and international variation	90 days
Length of Intensive Care Unit Admission	Length of stay for participants admitted to an ICU during SARI hospital admission	90 days
SARI Microbiology	Microbiological SARI diagnosis of participants (if known) during hospital admission	90 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global Ethical Approval requirements	Survey post SPRINT-SARI study period of ethical approval requirements in participating countries	90 days
Time requirements for obtaining Ethical approval	Survey post SPRINT-SARI study period of time required to obtain ethical approval for SPRINT-SARI at participating sites	90 days

Collaborators and Investigators

• Sponsor: Australian and New Zealand Intensive Care Research Centre
• Collaborators: International Severe Acute Respiratory and Emerging Infection Consortium; The International Forum of Acute Care Trialists

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: March 26, 2015
• First Submitted That Met QC Criteria: July 13, 2015
• First Posted (Estimated): July 15, 2015

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: August 7, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Severe Acute Respiratory Infection
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Respiratory Tract Infections
• Other Study ID Numbers: ANZIC-RC/SW0002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No