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NCT Number: NCT02498587

Short Period Incidence Study of Severe Acute Respiratory Illness

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.

Recruiting

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Key information

Conditions

Severe Acute Respiratory Infection

Sex eligibility

All sexes

Study type

Observational

Primary location

Australian and New Zealand Intensive Care Research Centre

Melbourne, Victoria, 3004, Australia

Location status: Recruiting

Location contact

Alexandre Demoule

PRINCIPAL_INVESTIGATOR

Alistair Nichol

PRINCIPAL_INVESTIGATOR

Allen Cheng

PRINCIPAL_INVESTIGATOR

Annane Djillali

PRINCIPAL_INVESTIGATOR

Behzad Nadjm

PRINCIPAL_INVESTIGATOR

Beth Riviello

PRINCIPAL_INVESTIGATOR

Calum Semple

PRINCIPAL_INVESTIGATOR

Colin McArthur

PRINCIPAL_INVESTIGATOR

Daniele Poole

PRINCIPAL_INVESTIGATOR

Dean Everett

PRINCIPAL_INVESTIGATOR

Djillali Annane

PRINCIPAL_INVESTIGATOR

Eoin West

PRINCIPAL_INVESTIGATOR

Evangelos Giamerellos

PRINCIPAL_INVESTIGATOR

Florence Pradel

PRINCIPAL_INVESTIGATOR

Gail Carson

PRINCIPAL_INVESTIGATOR

J.Perren Cobb

PRINCIPAL_INVESTIGATOR

Jake Dunning

PRINCIPAL_INVESTIGATOR

Jordi Rello

PRINCIPAL_INVESTIGATOR

Juilett Otieno

PRINCIPAL_INVESTIGATOR

Julia Guillebaud

PRINCIPAL_INVESTIGATOR

Karen Green

PRINCIPAL_INVESTIGATOR

Kathryn Maitland

PRINCIPAL_INVESTIGATOR

Kathy Rowan

PRINCIPAL_INVESTIGATOR

Kenneth Bailllie

PRINCIPAL_INVESTIGATOR

Mia Valkonein

PRINCIPAL_INVESTIGATOR

Michael Christian

PRINCIPAL_INVESTIGATOR

Nicole Ng, MBBS

CONTACT

[email protected]

Rachael Parke

PRINCIPAL_INVESTIGATOR

Rob Fowler

PRINCIPAL_INVESTIGATOR

Santiago Perez

PRINCIPAL_INVESTIGATOR

Srinivas Murthy

PRINCIPAL_INVESTIGATOR

Steven Webb

PRINCIPAL_INVESTIGATOR

T.Eoin West

PRINCIPAL_INVESTIGATOR

Tim Uyeki

PRINCIPAL_INVESTIGATOR

Tony Trapani

CONTACT

[email protected]

Won-il Choi

PRINCIPAL_INVESTIGATOR

Woni-il Choi

PRINCIPAL_INVESTIGATOR

Yaseen Arabi

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Nicole Ng, MBBS

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Australian and New Zealand Intensive Care Research Centre

Other

Collaborators

  • International Severe Acute Respiratory and Emerging Infection Consortium
  • The International Forum of Acute Care Trialists

Registry information

Acronym: SPRINT-SARI

Important dates

Study start
2016
Primary completion
2026
Study completion
2026
First posted
Jul 15, 2015
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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