Group A Streptococcus Saliva Study

Not Applicable

Active, not recruiting

• Conditions: Group A Streptococcal Infections
• Interventions: Diagnostic Test: Saliva collection

• Registration Number: NCT06473506
• Lead Sponsor: The Hospital for Sick Children

Brief Summary

This study is being done to evaluate whether saliva can be used to diagnose GAS infection and also to compare different testing methods in the microbiology lab. The saliva sample testing will be compared to the throat swab testing to see if saliva testing works as well. The lab will also try different testing methods to see if a faster type of testing (e.g. molecular testing) works as well as the regular method, which takes 48 hours to get results.

This is important because throat swabs can be challenging to collect in some children, and saliva is often much easier and more acceptable by children to collect. This could improve our ability to accurately diagnose and treat GAS infections.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-10
• Study First Submitted: 2024-06-17
• Study First Submitted QC: 2024-06-24
• Study First Posted: 2024-06-25
• Primary Completion: 2025-02-28
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-15
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• < 19 years of age
• Have provided a sample for GAS testing (bacterial throat swab or POCT rapid antigen test) at the discretion of the clinical team
• Able to provide a saliva sample

Exclusion Criteria

• Parent/guardian and/or patient unable to consent or assent
• Unable to provide a saliva sample

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Saliva collection	Saliva collection	Self-collected saliva sample

Primary Outcome Measures

Name	Time	Method
Rate and sensitivity of GAS detection	Within 24 hours of collection	compare the rate and sensitivity of GAS detection by throat bacterial culture, throat molecular detection and saliva molecular detection according to a semi-quantitative value (quantified growth on bacterial culture or CT value for molecular assays)

Trial Locations

Locations (2)

Monica Caldeira-Kulbakas; 🇨🇦 Toronto, Ontario, Canada

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada