Group A Streptococcal InfectionsNCT06473506
Group A Streptococcus Saliva Study
A study testing Saliva collection in people with Group A Streptococcal Infections, run by The Hospital for Sick Children at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Group A Streptococcal Infections
- What is being tested?
- Saliva collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesCanada
- Study dates
- 10 Jun 2024to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- < 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
Who cannot join
- Parent/guardian and/or patient unable to consent or assent
- Unable to provide a saliva sample
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Monica Caldeira-Kulbakas
Toronto, Ontario, M5G1X8
The Hospital for Sick Children
Toronto, Ontario
About this study
Official title: Exploring the Use of Saliva for the Detection of Group A Streptococcus
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
- Being tested
- Saliva collection
- Medical subject headings
- Streptococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saliva collectionDiagnostic test
Self-collected saliva sample with molecular testing performed. Results are compared to rapid antigen testing, bacterial throat culture and bacterial throat molecular testing
| Study group | Role | What they receive |
|---|---|---|
| Saliva collection | Other | Self-collected saliva sample Receives: Diagnostic Test: Saliva collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Within 24 hours of collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start10 Jun 2024
- Primary completion28 Feb 2025
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Group A Streptococcal InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aaron Campigotto, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06473506
- Sponsor's protocol ID
- 1000081444
- Status last verified
- Apr 2026
- First submitted
- 17 Jun 2024
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Use of Saliva for the Detection of Group A Streptococcus
- ClinicalTrials.gov ID
- NCT06473506
- Acronym / sponsor ID
- 1000081444
- Conditions
- Group A Streptococcal Infections
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 25 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Saliva collection | Other | Diagnostic Test: Saliva collectionSelf-collected saliva sample |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- < 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
Key exclusion criteria (2 listed)
- Parent/guardian and/or patient unable to consent or assent
- Unable to provide a saliva sample
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saliva collectionSelf-collected saliva sample with molecular testing performed. Results are compared to rapid antigen testing, bacterial throat culture and bacterial throat molecular testing | Diagnostic test | Saliva collection |
Primary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: No
Related trials for Group A Streptococcal Infections
Not yet recruitingObservational study
A Multicenter Evaluation of SalivIQ™ Strep A for Detecting Group A Streptococcus From Saliva and Throat Swabs in Patients With Acute Pharyngitis
Streptococcal Pharyngitis, Group A Streptococcal Infection
Not yet recruitingPhase 1
Stopping Strep Throat With Antibodies in Healthy Adults.
Streptococcal Pharyngitis
RecruitingPhase 3
Lot-to-lot Consistency Study of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From 2 Months of Age
Pneumococcal Immunization, Healthy Volunteers
Not yet recruitingPhase 4
Short Versus Standard Amoxicillin for Pediatric Strep Throat
Group A Streptococcal (GAS) Pharyngitis
Active, not recruiting
Evaluation of Efficacy of Antibacterial Activity of Licorice, Clove, and Chlorohexidine Mouthwashes on Salivary Streptococcus Mutans in a Group of Egyptian Children.
Dental Caries, Streptococcal Infections
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saliva collection in people with Group A Streptococcal Infections, run by The Hospital for Sick Children at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate and sensitivity of GAS detection (time frame: Within 24 hours of collection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.