Short Period Incidence Study of Severe Acute Respiratory Illness

NCT02498587 | Recruiting DMC

• 1 other identifier: ANZIC-RC/SW0002
• Study Type: observational
• Target: 15,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Acute Respiratory Infection

Keywords

Severe Acute Respiratory Infection

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Incidence of SARI

  one week

• Length of Hospital Stay

  90 days

• Symptoms at admission

  90 days

• Incidence of Intensive Care Unit Admission

  90 days

• Length of Intensive Care Unit Admission

  90 days

Other Outcomes (2)

• Global Ethical Approval requirements

  90 days

• Time requirements for obtaining Ethical approval

  90 days

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• A history of feverishness or measured fever of ≥ 38 deg C;
• Cough;
• Dyspnoea (shortness of breath) OR Tachypnoea.

Sponsors & Collaborators

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

Study Sites (1)

Australian and New Zealand Intensive Care Research Centre

Melbourne, Victoria, 3004, Australia

RECRUITING

Central Study Contacts

Nicole Ng, MBBS

CONTACT

mnhs-sprint.sari@monash.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2015
• First Posted: July 15, 2015
• Study Start: January 1, 2016
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share

Locations

AU (1)