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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 : February 7, 2023
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

Tracking Information
First Submitted Date March 26, 2015
First Posted Date July 15, 2015
Last Update Posted Date February 7, 2023
Actual Study Start Date January 2016
Estimated Primary Completion Date November 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 13, 2015)
  • Number of participating sites [ Time Frame: one week ]
    The number of sites able to participate and submit data for central analysis
  • Data Completeness [ Time Frame: 90 days ]
    The completeness of submitted data
  • Barriers to data submission [ Time Frame: 90 days ]
    Survey post SPRINT-SARI study period on barriers to data completion
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 13, 2015)
  • Incidence of SARI [ Time Frame: one week ]
    Number of participants during the study period at all sites
  • Length of Hospital Stay [ Time Frame: 90 days ]
    Length of stay of SARI patients by co-morbidities and risk factors
  • Symptoms at admission [ Time Frame: 90 days ]
    Impact of different SARI case definitions on cohort
  • Incidence of Intensive Care Unit Admission [ Time Frame: 90 days ]
    Rate of ICU admission in SARI cohorts and international variation
  • Length of Intensive Care Unit Admission [ Time Frame: 90 days ]
    Length of stay for participants admitted to an ICU during SARI hospital admission
  • SARI Microbiology [ Time Frame: 90 days ]
    Microbiological SARI diagnosis of participants (if known) during hospital admission
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 13, 2015)
  • Global Ethical Approval requirements [ Time Frame: 90 days ]
    Survey post SPRINT-SARI study period of ethical approval requirements in participating countries
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Short Period Incidence Study of Severe Acute Respiratory Illness
Official Title Short Period Incidence Study of Severe Acute Respiratory Illness
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.

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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.

Condition Severe Acute Respiratory Infection
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 13, 2015)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2024
Estimated Primary Completion Date November 2024   (Final data collection date for primary outcome measure)
Eligibility 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

Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Maya George, PhD 450974042 Maya.George@monash.edu
Listed Location Countries Australia
Removed Location Countries  
 
Administrative Information
NCT Number NCT02498587
Other Study ID Numbers ANZIC-RC/SW0002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Current Responsible Party Australian and New Zealand Intensive Care Research Centre
Original Responsible Party Same as current
Current Study Sponsor Australian and New Zealand Intensive Care Research Centre
Original Study Sponsor Same as current
Collaborators
  • International Severe Acute Respiratory and Emerging Infection Consortium
  • The International Forum of Acute Care Trialists
Investigators Not Provided
PRS Account Australian and New Zealand Intensive Care Research Centre
Verification Date August 2018