Short Period Incidence Study of Severe Acute Respiratory Illness

Severe Acute Respiratory Infection Clinical Trial

— SPRINT-SARI  

Official title:

Short Period Incidence Study of Severe Acute Respiratory Illness

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02498587
• Other study ID #: ANZIC-RC/SW0002
• Status: Recruiting
• Start date: January 2016
• Est. completion date: December 2024

Study information

• Verified date: August 2018
• Source: Australian and New Zealand Intensive Care Research Centre
• Contact: Maya George, PhD
• Phone: 450974042
• Email: Maya.George[@]monash.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Tract Infections
• Severe Acute Respiratory Infection

Locations

Country	Name	City	State
Australia	Australian and New Zealand Intensive Care Research Centre	Melbourne	Victoria

Sponsors (3)

Lead Sponsor	Collaborator
Australian and New Zealand Intensive Care Research Centre	International Severe Acute Respiratory and Emerging Infection Consortium, The International Forum of Acute Care Trialists

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Global Ethical Approval requirements	Survey post SPRINT-SARI study period of ethical approval requirements in participating countries	90 days
Other	Time requirements for obtaining Ethical approval	Survey post SPRINT-SARI study period of time required to obtain ethical approval for SPRINT-SARI at participating sites	90 days
Primary	Number of participating sites	The number of sites able to participate and submit data for central analysis	one week
Primary	Data Completeness	The completeness of submitted data	90 days
Primary	Barriers to data submission	Survey post SPRINT-SARI study period on barriers to data completion	90 days
Secondary	Incidence of SARI	Number of participants during the study period at all sites	one week
Secondary	Length of Hospital Stay	Length of stay of SARI patients by co-morbidities and risk factors	90 days
Secondary	Symptoms at admission	Impact of different SARI case definitions on cohort	90 days
Secondary	Incidence of Intensive Care Unit Admission	Rate of ICU admission in SARI cohorts and international variation	90 days
Secondary	Length of Intensive Care Unit Admission	Length of stay for participants admitted to an ICU during SARI hospital admission	90 days
Secondary	SARI Microbiology	Microbiological SARI diagnosis of participants (if known) during hospital admission	90 days