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

• ClinicalTrials.gov Identifier: NCT02498587
• Recruitment Status: Recruiting
• First Posted: July 15, 2015
• Last Update Posted: February 8, 2023
• 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
• Information provided by (Responsible Party): Australian and New Zealand Intensive Care Research Centre

Study Description

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.

Condition or disease
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 Design

• Study Type: Observational
• Estimated Enrollment: 1000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Short Period Incidence Study of Severe Acute Respiratory Illness
• Actual Study Start Date: January 2016
• Estimated Primary Completion Date: November 2024
• Estimated Study Completion Date: December 2024

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Number of participating sites [ Time Frame: one week ]
   The number of sites able to participate and submit data for central analysis
2. Data Completeness [ Time Frame: 90 days ]
   The completeness of submitted data
3. Barriers to data submission [ Time Frame: 90 days ]
   Survey post SPRINT-SARI study period on barriers to data completion

Secondary Outcome Measures :

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

Other Outcome Measures:

1. Global Ethical Approval requirements [ Time Frame: 90 days ]
   Survey post SPRINT-SARI study period of ethical approval requirements in participating countries
2. Time requirements for obtaining Ethical approval [ Time Frame: 90 days ]
   Survey post SPRINT-SARI study period of time required to obtain ethical approval for SPRINT-SARI at participating sites

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• 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.

Criteria

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

Contacts and Locations

Contacts

Contact: Maya George, PhD; 450974042; Maya.George@monash.edu

Locations

Australia, Victoria

Australian and New Zealand Intensive Care Research Centre; Recruiting

Melbourne, Victoria, Australia, 3004

Contact: Maya George, PhD +61 3 99030217 mnhs-sprint.sari@monash.edu

Contact: Lynne Murray +61 3 99030347 lynne.murray@monash.edu

Principal Investigator: Steven Webb

Principal Investigator: J.Perren Cobb

Principal Investigator: Rob Fowler

Principal Investigator: Colin McArthur

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: Alexandre Demoule

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

Sponsors and Collaborators

Australian and New Zealand Intensive Care Research Centre

International Severe Acute Respiratory and Emerging Infection Consortium

The International Forum of Acute Care Trialists

More Information

• Responsible Party: Australian and New Zealand Intensive Care Research Centre
• ClinicalTrials.gov Identifier: NCT02498587
• Other Study ID Numbers: ANZIC-RC/SW0002
• First Posted: July 15, 2015
• Last Update Posted: February 8, 2023
• Last Verified: August 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Australian and New Zealand Intensive Care Research Centre:

Severe Acute Respiratory Infection

Additional relevant MeSH terms:

Respiratory Tract Infections; Infections; Respiratory Tract Diseases