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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02498587




Registration number
NCT02498587
Ethics application status
Date submitted
26/03/2015
Date registered
15/07/2015
Date last updated
29/08/2018

Titles & IDs
Public title
Short Period Incidence Study of Severe Acute Respiratory Illness
Scientific title
Short Period Incidence Study of Severe Acute Respiratory Illness
Secondary ID [1] 0 0
ANZIC-RC/SW0002
Universal Trial Number (UTN)
Trial acronym
SPRINT-SARI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Severe Acute Respiratory Infection 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participating sites - The number of sites able to participate and submit data for central analysis
Timepoint [1] 0 0
one week
Primary outcome [2] 0 0
Data Completeness - The completeness of submitted data
Timepoint [2] 0 0
90 days
Primary outcome [3] 0 0
Barriers to data submission - Survey post SPRINT-SARI study period on barriers to data completion
Timepoint [3] 0 0
90 days
Secondary outcome [1] 0 0
Incidence of SARI - Number of participants during the study period at all sites
Timepoint [1] 0 0
one week
Secondary outcome [2] 0 0
Length of Hospital Stay - Length of stay of SARI patients by co-morbidities and risk factors
Timepoint [2] 0 0
90 days
Secondary outcome [3] 0 0
Symptoms at admission - Impact of different SARI case definitions on cohort
Timepoint [3] 0 0
90 days
Secondary outcome [4] 0 0
Incidence of Intensive Care Unit Admission - Rate of ICU admission in SARI cohorts and international variation
Timepoint [4] 0 0
90 days
Secondary outcome [5] 0 0
Length of Intensive Care Unit Admission - Length of stay for participants admitted to an ICU during SARI hospital admission
Timepoint [5] 0 0
90 days
Secondary outcome [6] 0 0
SARI Microbiology - Microbiological SARI diagnosis of participants (if known) during hospital admission
Timepoint [6] 0 0
90 days

Eligibility
Key inclusion criteria
- A history of feverishness or measured fever of = 38 deg C;

- Cough;

- Dyspnoea (shortness of breath) OR Tachypnoea.
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• No exclusion criteria

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Australian and New Zealand Intensive Care Research Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Australian and New Zealand Intensive Care Research Centre
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
International Severe Acute Respiratory and Emerging Infection Consortium
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
The International Forum of Acute Care Trialists
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT02498587
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Maya George, PhD
Address 0 0
Country 0 0
Phone 0 0
450974042
Fax 0 0
Email 0 0
Maya.George@monash.edu
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02498587