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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02498587
Recruitment Status : Recruiting
First Posted : July 15, 2015
Last Update Posted : August 29, 2018
Sponsor:
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

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.

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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 : October 2020
Estimated Study Completion Date : December 2022



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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02498587


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

Locations
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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
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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    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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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:
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Respiratory Tract Infections
Infection
Respiratory Tract Diseases