Accurate and robust collection of baseline data plays a critical role in the creation of a safe and effective vaccine.
That’s why our Sore Throat Study is seeking to establish baseline epidemiology of Strep A pharyngeal infection (sore throats caused by bacteria). It’s a first vital step toward a vaccine clinical trial, but we can’t do it without the help of GPs and our community.
Our study aims to determine the incidence rates of bacterial sore throats in our community. Rates will be based on culture positive serologically proven Strep A infections.
The study will run in Perth and Melbourne. We’re aiming to recruit a total of 1050 healthy children, aged three to 14 years, to participate.
I’m a GP and interested in taking part. What do I need to know?
We welcome your participation. GPs who take part in the study will be asked to invite families who attend their practice with at least one child aged between three and 14 years. Recruitment materials will be provided by the research team.
Once enrolled, participants will present to their GP clinic when they experience a sore throat. You’ll also be asked to complete a GP “trigger visit” when a study participant presents with any signs or symptoms of a sore throat. This involves:
- Collecting clinical information about the child’s episode of sore throat.
- Using Point of Care testing machines to rapidly and accurately diagnose the child’s sore throat.
- Collecting biospecimens (throat swabs and blood samples) from the child during a sore throat episode.
GPs and practice nurses are also invited to be actively involved in these activities.
How do point of care test machines work?
The point of care testing device will play a major role in the Sore Throat Study. We will provide GPs with the Abbott ID NOW™ device which detects a gene highly specific for Strep A. This device works by using a throat swab collected from a participant during a GP trigger visit.
Positive results are detected in approximately two minutes and negative results in six minutes.
Rapid results will help guide the GP to prescribe the best treatment for sore throat management.
Are there any patients who aren’t eligible to participate?
Yes. Exclusion criteria include children outside the age range or those who are immune compromised, have a serious medical condition or have an inability to tolerate a throat swab.
Why join us?
The study offers a unique opportunity to participate in research and contribute to Strep A vaccine development. This study is being conducted in collaboration with general practices, and offers GPs:
- The opportunity to engage in medical research and join as Associate Investigators.
- Remuneration for GPs and practices.
- Access to a point of care testing device.
- High levels of support from the research team.
- Royal Australian College of General Practitioners’ (RACGP) Continuing Professional Development (CPD) points.