Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625001090404
Ethics application status
Approved
Date submitted
5/09/2025
Date registered
7/10/2025
Date last updated
7/10/2025
Date data sharing statement initially provided
7/10/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of Strep A point-of-care testing in reducing antibiotic use in patients with acute sore throat infections
Scientific title
Effect of Strep A point-of-care testing in reducing antibiotic use in patients with acute sore throat infections: a pilot pragmatic cluster randomised controlled trial
Secondary ID [1] 315319 0
2025DUCT022
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute sore throat 338795 0
Pharyngitis infection 338891 0
Pharyngotonsillitis 338892 0
Condition category
Condition code
Respiratory 335085 335085 0 0
Other respiratory disorders / diseases
Infection 335297 335297 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Name: Group A Streptococcus point-of-care testing
Description:
-ID NOW™ Strep A 2 is a rapid, instrument-based, molecular in vitro diagnostic test utilizing isothermal nucleic acid amplification technology for the qualitative detection of Streptococcus pyogenes, Group A Streptococcus bacterial nucleic acid in throat swab specimens obtained from patients with signs and symptoms of pharyngitis/sore throat.
-It is comprised of a Sample Receiver, containing elution buffer, a Test Base, comprising two sealed reaction tubes, each containing a lyophilized pellet, a Transfer Cartridge for transfer of the eluted sample to the Test Base, and the ID NOW Instrument. The reaction tubes in the Test Base contain the reagents required for Group A Strep bacterial lysis and the subsequent amplification of the target nucleic acid and an internal control. To perform the assay, the Sample Receiver and Test Base are inserted into the ID NOW Instrument. The sample is added to the Sample Receiver and transferred via the Transfer Cartridge to the Test Base, initiating bacterial lysis and target amplification. Heating, mixing and detection are provided by the instrument, with results automatically reported.
-Either a GP or a nurse will do the test for the eligible patients determined by GPs.
-GP will discuss the test and outcomes with the patients.
-The research team will train GPs and nurses about how to do the testing and share relevant information.
- The duration of the once-off training will be for 30-40 minutes.
- The mode of training will be face-to-face in-person training.
- The training will occur two weeks before intervention commencement.
-The anticipated time to complete a test is about 10 minutes.
-The user manual of the test will be printed and placed near the test machine to follow the steps properly. In case any errors or issues are raised, test users will contact the researcher (Sajal Saha) to ensure adherence to test use.
-The overall duration of the intervention period will be 4 months [ID NOW™ will be available to intervention GPs for four months]
Intervention code [1] 331918 0
Diagnosis / Prognosis
Comparator / control treatment
Control: GP clinics without testing provision will serve as control practices, following usual care. The GPs' care will reflect the care as usually received by patients in daily practice. Upon randomisation, control GP practices will continue with normal care. Patients may or may not be throat swabbed by GPs. This is up to the GP's own decisions. This study does not recommend anything to the control practice GPs related to the diagnosis or treatment of the patients.
Control group
Active

Outcomes
Primary outcome [1] 342717 0
1. Changes in the composite antibiotic prescriptions related to either sore throat/ pharyngitis/pharyngotonsillitis
Timepoint [1] 342717 0
Four months of data will be collected post-randomisation to the intervention or control group
Secondary outcome [1] 451904 0
1. Proportion of patients tested for GAS (rate of service uptake) in the intervention practices
Timepoint [1] 451904 0
Four months of data will be collected post-randomisation to the intervention or control group
Secondary outcome [2] 452168 0
2. Changes in the proportion of patients (sore throat/pharyngitis/pharyngotonsilitis) who received broad-spectrum antibiotics;
Timepoint [2] 452168 0
Four months of data will be collected post-randomisation to the intervention or control group
Secondary outcome [3] 452169 0
3. Changes in the duration of prescribed antibiotic therapy in sore throat/ pharyngitis/pharyngotonsilitis patients.
Timepoint [3] 452169 0
Four months of data will be collected post-randomisation to the intervention or control group
Secondary outcome [4] 452170 0
4. Implementation feasibility and acceptability of the GAS testing.
Timepoint [4] 452170 0
Within four months of post-implementation of the intervention.

Eligibility
Key inclusion criteria
1. Patient age >3 Years
2. Must have sore throat/ pharyngitis or pharyngotonsillitis symptoms as judged by the clinician
Minimum age
4 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Sore throat patients who are already taking antibiotics.
2. Critical patients who need immediate hospital referral.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/08/2025
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
20/02/2026
Actual
Sample size
Target
360
Accrual to date
60
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 319893 0
Charities/Societies/Foundations
Name [1] 319893 0
Shepherd Foundation Grant
Country [1] 319893 0
Australia
Funding source category [2] 319899 0
University
Name [2] 319899 0
Deakin HAtCH Grant
Country [2] 319899 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Country
Australia
Secondary sponsor category [1] 322422 0
None
Name [1] 322422 0
Address [1] 322422 0
Country [1] 322422 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318444 0
Barwon Health HREC
Ethics committee address [1] 318444 0
Ethics committee country [1] 318444 0
Australia
Date submitted for ethics approval [1] 318444 0
19/02/2025
Approval date [1] 318444 0
29/04/2025
Ethics approval number [1] 318444 0
Ethics committee name [2] 318445 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [2] 318445 0
Ethics committee country [2] 318445 0
Australia
Date submitted for ethics approval [2] 318445 0
13/05/2025
Approval date [2] 318445 0
06/06/2025
Ethics approval number [2] 318445 0
2025/HE000597

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

Contacts
Principal investigator
Name 144218 0
Prof Eugene Athan
Address 144218 0
Deakin University, Locked Bag 20000, Geelong, VIC 3220
Country 144218 0
Australia
Phone 144218 0
+61 0416070897
Fax 144218 0
Email 144218 0
[email protected]
Contact person for public queries
Name 144219 0
Sajal Kumar Saha
Address 144219 0
Deakin University, Locked Bag 20000, Geelong, VIC 3220
Country 144219 0
Australia
Phone 144219 0
+61 0416572674
Fax 144219 0
Email 144219 0
[email protected]
Contact person for scientific queries
Name 144220 0
Sajal Kumar Saha
Address 144220 0
Deakin University, Locked Bag 20000, Geelong, VIC 3220
Country 144220 0
Australia
Phone 144220 0
+61 0416572674
Fax 144220 0
Email 144220 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.