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Group A Streptococcus Saliva Study

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06473506
Enrollment
200
Registered
2024-06-25
Start date
2024-06-10
Completion date
2026-08-31
Last updated
2026-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Group A Streptococcal Infections

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.

Interventions

DIAGNOSTIC_TESTSaliva collection

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

Sponsors

The Hospital for Sick Children
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
0 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Rate and sensitivity of GAS detectionWithin 24 hours of collectioncompare 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)

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 8, 2026