Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000383460p
Ethics application status
Submitted, not yet approved
Date submitted
14/04/2025
Date registered
30/04/2025
Date last updated
30/04/2025
Date data sharing statement initially provided
30/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
SToPPING Acute Rheumatic Fever (ARF) skin Trial
Scientific title
Evaluating the effect of Skin infection Testing at the Point of care on Incidence of Group A Strep infections & ARF
Secondary ID [1] 313883 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Group A Streptococcus (GAS) infection 336629 0
Acute Rheumatic Fever (ARF) 337106 0
Rheumatic Heart Disease (RHD) 337107 0
Condition category
Condition code
Skin 333092 333092 0 0
Other skin conditions
Inflammatory and Immune System 333093 333093 0 0
Other inflammatory or immune system disorders
Public Health 333590 333590 0 0
Health service research
Cardiovascular 333591 333591 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention in this study will be the utilisation of the Roche Diagnostics cobas Liat Strep A Point of Care Test (PoCT) for GAS (Group A Streptococcus) infection for diagnosis of impetigo and other skin infections. Trained health service staff at designated regional/remote Australian health clinic sites will take a swab of the patient's skin sore with a long cotton bud like testing stick which is transferred to a liquid amies media collection tube. Liquid from the collection tube is transferred to the cobas Liat Strep A test tube for testing on the cobas Liat machine for detection of GAS infection. This result takes approximately 15 minutes. The result from the test will not inform the clinical treatment of patients, and clinicians will treat as per standard of care clinical guidelines. The result from the swab will be recorded in study case report forms and may be recorded in the clinics patient management system should they wish to. The skin swab will then be sent to a laboratory for comparison testing using the standard microbial culture.
Intervention code [1] 330488 0
Early detection / Screening
Intervention code [2] 330489 0
Diagnosis / Prognosis
Intervention code [3] 330532 0
Prevention
Comparator / control treatment
The sensitivity and specificity of the Roche cobas Liat Strep A PoCT for Group A Streptococcus infection for diagnosis of impetigo lesions in a field (regional or remote) setting will be compared to a microbial culture reference laboratory standard.
Control group
Active

Outcomes
Primary outcome [1] 340631 0
The sensitivity of the Roche cobas Liat Strep A PoCT for Group A Streptococcus infection for diagnosis of skin lesions compared to a reference laboratory standard.
Timepoint [1] 340631 0
Completion of the trial
Primary outcome [2] 341170 0
The specificity of the Roche cobas Liat Strep A PoCT for Group A Streptococcus infection for diagnosis of skin lesions compared to a reference laboratory standard.
Timepoint [2] 341170 0
Completion of the trial
Secondary outcome [1] 444658 0
Monitor overall rates of clinic presentations due to skin infection issues in 0 to 18-year-olds during the study period.
Timepoint [1] 444658 0
Collected at regular intervals throughout the trial.
Secondary outcome [2] 444659 0
Monitoring of rates of antibiotic prescription for skin infections and other conditions.
Timepoint [2] 444659 0
Collected at regular intervals throughout the trial.
Secondary outcome [3] 444660 0
Investigating the cost effectiveness of the integration of the PoCT into clinical practice in an ARF/RHD endemic region.
Timepoint [3] 444660 0
Completion of the trial
Secondary outcome [4] 444661 0
Operational/clinical acceptability of the PoCT to health service staff in regional and remote community settings.
Timepoint [4] 444661 0
Completion of the trial

Eligibility
Key inclusion criteria
1. Aged 0-< /=18 years
2. Parent or guardian willing and able to provide informed consent
3. Patients presenting to clinic with impetigo or other skin issue that has not been diagnosed or treated in the preceding 14 days
4. Patients with impetigo or other skin issue identified during routine clinical examination and have not been diagnosed or received treatment for skin issues in the preceding 14 days
Minimum age
0 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Aged > 18 years
2. Diagnosed or treated for impetigo or other skin issue in the preceding 14 days
3. Cannot provide informed consent

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Cobas Liat point of care test results will be compared to the current reference laboratory gold standard of microbial culture.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Descriptive statistics will be used to analyse and summarise quantitative secondary outcomes. Comparisons between cohort characteristics will be performed using one-way analysis of variance (ANOVA) or appropriate non-parametric tests for continuous variables. Differences between categorical variables with be assessed by chi-square tests, or other techniques as appropriate. In all cases, the level of significance is taken as p<0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2025
Actual
Date of last participant enrolment
Anticipated
6/07/2026
Actual
Date of last data collection
Anticipated
6/07/2026
Actual
Sample size
Target
365
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 318353 0
Government body
Name [1] 318353 0
CSIRO Health and Biosecurity
Country [1] 318353 0
Australia
Funding source category [2] 318371 0
Charities/Societies/Foundations
Name [2] 318371 0
Snow Family Foundation
Country [2] 318371 0
Australia
Funding source category [3] 318775 0
Commercial sector/Industry
Name [3] 318775 0
Roche Diagnostics - in kind contribution of devices and testing kits
Country [3] 318775 0
Australia
Primary sponsor type
Government body
Name
CSIRO Health and Biosecurity
Address
Country
Australia
Secondary sponsor category [1] 321006 0
None
Name [1] 321006 0
Address [1] 321006 0
Country [1] 321006 0
Other collaborator category [1] 283453 0
Commercial sector/Industry
Name [1] 283453 0
Roche Diagnostics Australia Pty Limited
Address [1] 283453 0
Country [1] 283453 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316984 0
Cairns and Hinterland Hospital and Health Service HREC
Ethics committee address [1] 316984 0
Ethics committee country [1] 316984 0
Australia
Date submitted for ethics approval [1] 316984 0
17/04/2025
Approval date [1] 316984 0
Ethics approval number [1] 316984 0
Ethics committee name [2] 317340 0
CSIRO Health and Medical Human Research Ethics Committee
Ethics committee address [2] 317340 0
Ethics committee country [2] 317340 0
Australia
Date submitted for ethics approval [2] 317340 0
19/05/2025
Approval date [2] 317340 0
Ethics approval number [2] 317340 0

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

Contacts
Principal investigator
Name 139654 0
Prof Raymond Mahoney
Address 139654 0
CSIRO, Australian eHealth Research Centre, 296 Herston Rd, Herston QLD 4006
Country 139654 0
Australia
Phone 139654 0
+61 0401141397
Fax 139654 0
Email 139654 0
[email protected]
Contact person for public queries
Name 139655 0
Raymond Mahoney
Address 139655 0
CSIRO, Australian eHealth Research Centre, 296 Herston Rd, Herston QLD 4006
Country 139655 0
Australia
Phone 139655 0
+61 0401141397
Fax 139655 0
Email 139655 0
[email protected]
Contact person for scientific queries
Name 139656 0
Hannah Law
Address 139656 0
CSIRO, Australian eHealth Research Centre, 296 Herston Rd, Herston QLD 4006
Country 139656 0
Australia
Phone 139656 0
+61 0429366433
Fax 139656 0
Email 139656 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Individual raw line by line data will not be shared.



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.