RecruitingACTRN12625001090404

Effect of Strep A point-of-care testing in reducing antibiotic use in patients with acute sore throat infections

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


Sponsor

Deakin University

Enrollment

360 participants

Start Date

Aug 1, 2025

Study Type

Interventional

Conditions

Summary

Group A Streptococcus Point-of-Care Testing (GAS POCT) service can play an important role in diagnosing bacterial pharyngitis and optimising antibiotic use. This pilot cluster randomised controlled trial assesses the effectiveness of GAS testing in reducing antibiotic use in general practices for new onset acute sore throat/pharyngitis/pharyngotonsillitis infections. The study also underpins the experiences and challenges of GPs while using the GAS testing in routine patient care through post-implementation interviews.


Eligibility

Sex: Both males and femalesMin Age: 4 Yearss

Plain Language Summary

Simplified for easier understanding

Sore throats are one of the most common reasons people visit a GP, and they are also one of the most common reasons antibiotics get prescribed — even though the majority of sore throats are caused by viruses, not bacteria. This study is testing whether using a rapid point-of-care test for Group A Streptococcus (the bacteria that causes strep throat) in GP clinics can help doctors prescribe antibiotics only when they are truly needed. GP clinics will be randomly assigned to either offer the rapid strep test to patients or continue with their usual practice. Researchers will then compare antibiotic prescribing rates between the two groups. Doctors will also be interviewed about their experiences using the test in their daily work. You may be eligible if you are older than 3 years and have come to see a GP with a new sore throat, pharyngitis, or tonsil infection. People who are already taking antibiotics or who are critically unwell and need immediate hospital referral are not eligible for this study.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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 te

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]


Locations(1)

VIC, Australia

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ACTRN12625001090404