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 7, 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

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

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

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

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