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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02498587
Registration number
NCT02498587
Ethics application status
Date submitted
26/03/2015
Date registered
15/07/2015
Titles & IDs
Public title
Short Period Incidence Study of Severe Acute Respiratory Illness
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Scientific title
Short Period Incidence Study of Severe Acute Respiratory Illness
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Secondary ID [1]
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ANZIC-RC/SW0002
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Universal Trial Number (UTN)
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Trial acronym
SPRINT-SARI
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Severe Acute Respiratory Infection
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Infection
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Other infectious diseases
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Infection
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0
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Studies of infection and infectious agents
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of participating sites
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Assessment method [1]
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The number of sites able to participate and submit data for central analysis
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Timepoint [1]
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one week
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Primary outcome [2]
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Data Completeness
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Assessment method [2]
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The completeness of submitted data
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Timepoint [2]
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90 days
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Primary outcome [3]
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Barriers to data submission
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Assessment method [3]
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Survey post SPRINT-SARI study period on barriers to data completion
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Timepoint [3]
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90 days
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Secondary outcome [1]
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Incidence of SARI
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Assessment method [1]
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Number of participants during the study period at all sites
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Timepoint [1]
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one week
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Secondary outcome [2]
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Length of Hospital Stay
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Assessment method [2]
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Length of stay of SARI patients by co-morbidities and risk factors
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Timepoint [2]
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90 days
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Secondary outcome [3]
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Symptoms at admission
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Assessment method [3]
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Impact of different SARI case definitions on cohort
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Timepoint [3]
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90 days
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Secondary outcome [4]
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Incidence of Intensive Care Unit Admission
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Assessment method [4]
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Rate of ICU admission in SARI cohorts and international variation
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Timepoint [4]
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90 days
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Secondary outcome [5]
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Length of Intensive Care Unit Admission
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Assessment method [5]
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Length of stay for participants admitted to an ICU during SARI hospital admission
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Timepoint [5]
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90 days
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Secondary outcome [6]
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SARI Microbiology
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Assessment method [6]
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Microbiological SARI diagnosis of participants (if known) during hospital admission
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Timepoint [6]
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90 days
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Eligibility
Key inclusion criteria
* A history of feverishness or measured fever of = 38 deg C;
* Cough;
* Dyspnoea (shortness of breath) OR Tachypnoea.
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
• No exclusion criteria
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2026
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Actual
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Sample size
Target
15000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Australian and New Zealand Intensive Care Research Centre - Melbourne
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Australian and New Zealand Intensive Care Research Centre
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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International Severe Acute Respiratory and Emerging Infection Consortium
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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The International Forum of Acute Care Trialists
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT02498587
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Nicole Ng, MBBS
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Address
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Country
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Phone
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02498587