A Quantitative and Comparative Study for the Detection of Group A β-Hemolytic Streptococci in Patient Throat Gargle
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Comparative: Method sensitivity to investigate method effectiveness.
研究概览
简要总结
The objective of this study is to investigate the use of patient throat gargle as an alternative to throat swabbing for the diagnosis of pharyngitis caused by Group A β-Hemolytic Streptococcus (GABHS) infection, also known as strep throat.
详细描述
The aim of this study is to procure a detailed quantitative and qualitative analysis of GABHS present in patient throat gargle and to compare various culturing techniques and immunoassay methods for efficient and effective GABHS detection from gargle fluid. During the course of this clinical trial, the following specimen samples will be collected from each participating patient: the patient will first be asked to gargle 10-15 mL of sterile saline to obtain a gargle sample, and then the patient will be subjected to two routine standard throat swabs. These specimen samples will be properly discarded after processing and analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older.
- •Suspected of suffering from GABHS pharyngitis.
- •Able to communicate with study personnel (English or Hebrew).
- •Able to understand oral and written information about the study.
- •Willing to provide written informed consent to participate in the study.
排除标准
- •Not capable of gargling 10-15 mL fluid.
- •Diagnosed or self-reported pregnancy.
- •History of dementia, cognitive impairment, or psychiatric or mental disorders.
结局指标
主要结局
Comparative: Method sensitivity to investigate method effectiveness.
时间窗: Through study completion, about 9 months
Compare sensitivity of each gargle fluid GABHS detection method.
Comparative: Method specificity to investigate method effectiveness.
时间窗: Through study completion, about 9 months
Compare specificity of each gargle fluid GABHS detection method.
次要结局
- Quantitative: Average GABHS in gargle.(Through study completion, about 9 months)
- Quantitative: Minimum GABHS in gargle.(Through study completion, about 9 months)