CClinicalTrials.gg
Active, not recruitingNCT06473506Updated May 7, 2026

Group A Streptococcus Saliva Study

An interventional study of Saliva collection in Group A Streptococcal Infections, sponsored by The Hospital for Sick Children. Active, not recruiting at 2 sites in Canada. Open to participants aged 0 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-05-07.

Sponsored by The Hospital for Sick Children · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Not applicable
Ages
0 Years to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Group A Streptococcal Infections
03

In context

Streptococcal Infections

155 studies on the registry are indexed under Streptococcal Infections; 15 are open to participants now.

This study's planned enrollment of 200 is below the median of 250 across 105 interventional studies indexed under Streptococcal Infections.

Browse Streptococcal Infections studies →

Lead sponsor

The Hospital for Sick Children is the lead sponsor of 568 studies on the registry; 81 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Years to 18 Years
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • Parent/guardian and/or patient unable to consent or assent
  • Unable to provide a saliva sample
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Other
    Saliva collection

    Self-collected saliva sample

    Diagnostic Test: Saliva collection

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

06

What researchers measure

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)

    Time frame: Within 24 hours of collection

07

Study locations

2 sites
  • Monica Caldeira-Kulbakas
    Toronto, Ontario M5G1X8, Canada
  • The Hospital for Sick Children
    Toronto, Ontario, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06473506
Lead sponsor
The Hospital for Sick Children
Responsible party
Aaron Campigotto (Division Head Microbiology, The Hospital for Sick Children) — Principal investigator
First posted
Jun 25, 2024
Start date
Jun 10, 2024
Primary completion
Feb 28, 2025
Completion
Aug 31, 2026 (estimated)
Last update
May 7, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion