Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001222639
Ethics application status
Approved
Date submitted
1/11/2023
Date registered
28/11/2023
Date last updated
28/11/2023
Date data sharing statement initially provided
28/11/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Bacterial evolution during golden staph infections
Scientific title
Bacterial Adaptation during Invasive Staphylococcus aureus infections
Secondary ID [1] 310883 0
None
Universal Trial Number (UTN)
Trial acronym
BARISTA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Staphylococcus aureus infections 331930 0
Sepsis 331932 0
Bone and joint infections 331933 0
Infective endocarditis 331934 0
Condition category
Condition code
Infection 328661 328661 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Invasive S. aureus infection (at least 1 sterile sample with growth of S. aureus [e.g. blood, valve, bone]) admitted at Austin and Royal Melbourne Hospitals in Melbourne, Victoria
Following samples are collected:
1. At enrolment and during the initial admission:
- all clinical samples with growth of S. aureus: blood cultures, tissue biopsies (e.g. bone, muscle), body liquids (e.g. joint fluid), pus from abscesses. These samples are already collected for clinical reasons, no additional intervention required
- a nasal swab (collected by a registered nurse)
- a 9 ml blood sample at enrolment, after 3 days and after 7 days (collected by a registered nurse)
2. At follow-up at 6 and 12 months after enrolment:
- nasal swab (self collection)
3. At infection recurrence within 12 months:
- all clinical samples with growth of S. aureus: blood cultures, tissue biopsies (e.g. bone, muscle), body liquids (e.g. joint fluid), pus from abscesses. These samples are already collected for clinical reasons, no additional intervention required
- a nasal swab (collected by a registered nurse)
- a 9 ml blood sample at enrolment, after 3 days and after 7 days (collected by a registered nurse)
Intervention code [1] 327303 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336457 0
Any adaptative changes, defined as point mutations, chromosoma structural changes acquired withih the host overt the course of the infection with S. aureus
Timepoint [1] 336457 0
One year post enrolment
Primary outcome [2] 336458 0
Bacterial diversity within clinical samples (i.e genetic heterogeneity of the S. aureus population)
Timepoint [2] 336458 0
At time of enrolment, at 6 and 12 months follow-up and at infection recurrence
Secondary outcome [1] 428476 0
Treatment failure (mortality at 30 days, persistent bacteraemia > 7 days or recurrence within a year)
Timepoint [1] 428476 0
One year post enrolment

Eligibility
Key inclusion criteria
• Age greater or equal to 18 years
• Admitted to a participating centre
• Invasive S. aureus infection (at least 1 sterile sample with growth of S. aureus [e.g. blood, valve, bone])
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Polymicrobial infection at time of inclusion
• Treating team deems enrolment in the study is not in the best interest of the patient
• Death is deemed to be imminent and inevitable within the next 48 hours

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/05/2021
Date of last participant enrolment
Anticipated
31/12/2024
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
200
Accrual to date
32
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 25799 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [2] 25800 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 41624 0
3084 - Heidelberg
Recruitment postcode(s) [2] 41625 0
3050 - Parkville

Funding & Sponsors
Funding source category [1] 315142 0
University
Name [1] 315142 0
University of Melbourne
Country [1] 315142 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Grattan Street, Parkville, Victoria, 3010
Country
Australia
Secondary sponsor category [1] 317162 0
None
Name [1] 317162 0
Address [1] 317162 0
Country [1] 317162 0
Other collaborator category [1] 282864 0
Other Collaborative groups
Name [1] 282864 0
SNAP trial steering committee (principal investigators: Prof. Steve Tong and Prof. Josh Davis)
Address [1] 282864 0
Doherty Institute, 792 Elizabeth Street, Melbourne, VIC 3000
Country [1] 282864 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314080 0
Austin Health Human Research Ethics committee
Ethics committee address [1] 314080 0
Ethics committee country [1] 314080 0
Australia
Date submitted for ethics approval [1] 314080 0
26/02/2021
Approval date [1] 314080 0
03/03/2021
Ethics approval number [1] 314080 0
HREC/64786/Austin-2020

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130338 0
Prof Ben Howden
Address 130338 0
The Doherty Institute, 792 Elizabeth Street, Melbourne VIC 3000
Country 130338 0
Australia
Phone 130338 0
+61 3 8344 5701
Fax 130338 0
Email 130338 0
[email protected]
Contact person for public queries
Name 130339 0
Stefano Giulieri
Address 130339 0
The Doherty Institute, 792 Elizabeth Street, Melbourne VIC 3000
Country 130339 0
Australia
Phone 130339 0
+61 3 8344 5701
Fax 130339 0
Email 130339 0
[email protected]
Contact person for scientific queries
Name 130340 0
Stefano Giulieri
Address 130340 0
The Doherty Institute, 792 Elizabeth Street, Melbourne VIC 3000
Country 130340 0
Australia
Phone 130340 0
+61 3 8344 5701
Fax 130340 0
Email 130340 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Clinical data
Bacterial genomes
When will data be available (start and end dates)?
Data available as soon as manuscript published (2026). No end date.
Available to whom?
In public repositories or a supplementary data
Available for what types of analyses?
Genomic analyses
How or where can data be obtained?
From public repositories or a supplementary data. Contact coordinator Stefano Giulieri, [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.