Group A Streptococcus Saliva Study

NCT06473506 | Active Not Recruiting

• 1 other identifier: 1000081444
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Group A Streptococcal Infections

Outcome Measures

Primary Outcomes (1)

• Rate and sensitivity of GAS detection

  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)

  Within 24 hours of collection

Study Arms (1)

Saliva collection

OTHER

Self-collected saliva sample

Diagnostic Test: Saliva collection

Interventions

Saliva collection DIAGNOSTIC_TEST

Self-collected saliva sample with molecular testing performed. Results are compared to rapid antigen testing, bacterial throat culture and bacterial throat molecular testing

Saliva collection

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \< 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

You may not qualify if:

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

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (2)

Monica Caldeira-Kulbakas

Toronto, Ontario, M5G1X8, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Streptococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Head Microbiology

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: June 25, 2024
• Study Start: June 10, 2024
• Primary Completion: February 28, 2025
• Study Completion: April 30, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)