Exploring the Use of Saliva for the Detection of Group A Streptococcus
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Rate and sensitivity of GAS detection
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •< 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
排除标准
- •Parent/guardian and/or patient unable to consent or assent
- •Unable to provide a saliva sample
结局指标
主要结局
Rate and sensitivity of GAS detection
时间窗: 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)
次要结局
未报告次要终点
研究者
Aaron Campigotto
Division Head Microbiology
The Hospital for Sick Children