Group A Streptococcus Saliva Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Group A Streptococcal Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Streptococcal Infections

Age range

0 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Monica Caldeira-Kulbakas, Toronto, Ontario, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

Rate and sensitivity of GAS detection

Time frame: 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)

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

Exploring the Use of Saliva for the Detection of Group A Streptococcus

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2026
First posted: Jun 25, 2024
Registry last updated: May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting