A Semi-Quantitative and Comparative Study for the Detection of Group A β-Hemolytic Streptococci in Oral Samples
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- quantify and compare the amount of GABHS
研究概览
简要总结
This prospective, sample collection study will assess different oral and/or nasal sample types collected from patients suspected of suffering from GABHS pharyngitis to conduct research and development on innovative GABHS detection methods specific for each sample type.
详细描述
Study candidates are patients age 3 and older with complaints of sore throat and are suspected of suffering from GABHS pharyngitis. Patients who consent and are found eligible will be enrolled in the study. Subjects will be tested according to the conventional standard of care in addition to providing extra specimen samples for the study.
After each patient has been tested according to conventional SOC and has enrolled in the study, up to ten oral and/or nasal specimen samples will be collected . Study participation is complete once all specimen samples are collected.
Most or all collected samples will be qualitatively tested and may also be quantitatively and/or semi-quantitatively tested for the presence of GABHS. Some collected samples may additionally or alternatively be tested for other respiratory infections as well. (such as SARS-CoV-2, influenza, etc.)
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient, either male or female, is age 3 years or older;
- •Patient is suspected of suffering from GABHS pharyngitis, and is prescribed a throat culture by conventional SOC;
- •Patient or legal guardian is able to communicate with study personnel;
- •Patient or legal guardian is able to understand oral and written information regarding the nature of the study and is willing to provide written informed consent.
排除标准
- •Patients presently on antibiotics prescribed by a physician for treatment or prevention of GAS infection or has taken antibiotics within the past 3 days ( unless patient only first started taking antibiotics within the past 24 hour)
- •Patients who took mouth rinse or taking oral treatment for mouth sores within 3 hours of study
结局指标
主要结局
quantify and compare the amount of GABHS
时间窗: Study participation ( 1 day participation)
quantify the amount of GABHS contained in different oral and/or nasal sample types collected from patients who have been diagnosed with GABHS pharyngitis
compare the amount of GABHS in different oral and/or nasal samlpes
时间窗: Study participation ( 1 day participation)
Compare the amount of GABHS contained in different oral and/or nasal sample types collected from patients who have been diagnosed with GABHS pharyngitis
次要结局
- assess the efficacy of potential GABHS detection methods specifically designed for each oral and/or nasal sample type(Study participation ( 1 day participation))