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Clinical Trials/NCT06473506
NCT06473506Active, not recruitingNot Applicable

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

The Hospital for Sick Children4 sites in 1 country200 target enrollmentStarted: June 10, 2024Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
200
Locations
4
Primary Endpoint
Rate and sensitivity of GAS detection
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
0 Years to 18 Years (Child, Adult)
Sex
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

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

Arms & Interventions

Saliva collection

Other

Self-collected saliva sample

Intervention: Saliva collection (Diagnostic Test)

Outcomes

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)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Aaron Campigotto

Division Head Microbiology

The Hospital for Sick Children

Study Sites (4)

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