Group A Streptococcus Saliva Study

N/AActive Not RecruitingNCT06473506

The Hospital for Sick Children200 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

200

Conditions

Group A Streptococcal Infections

Interventions

Eligibility

Sex: ALLMin age: 0 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Monica Caldeira-Kulbakas

Toronto, Ontario, Canada

The Hospital for Sick Children

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

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