A Comparison of Available Rapid Streptococcus A Tests in Community Clinics in Israel: Accuracy, Ease of Use and Acceptability.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7,000
- 试验地点
- 1
- 主要终点
- sensitivity of RST specificity of RST
研究概览
简要总结
There is a large over-use of antibiotics in family medicine, especially in upper respiratory tract infections.
This study is designed to determine if the use of rapid Streptococcal tests in primary care clinics can lower the rate of antibiotic use while not missing bacterial infections.
详细描述
Pharyngitis is a clinical diagnosis which requires antibiotic treatment only if caused by group A Streptococcus (GAS).
However, it is impossible to identify by clinical signs alone those patients whose symptoms are caused by this pathogen.
Diagnosis demands a throat culture, which requires at least 24 hours to rule in infection and 48 hours to rule it out.
Rapid Streptococcal tests (RST) based on antigen identification have been in use for over 10 years. These allow determination of the presence of GAS within 10 minutes using tests designed for point of care use.
While the specificity of these tests is generally reported as high (90-95%), the sensitivity is quoted at between 60% and 90% , depending on author affiliation, place of testing and type of test.
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
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •sore throat
- •at least two Centor criteria:
- •fever > 38 deg C or history of fever
- •enlarged cervical lymph nodes
- •tonsillar exudate
- •lack of cough
- •age 3-14 years
排除标准
- •antibiotic treatment in preceding 7 days
- •no informed consent
结局指标
主要结局
sensitivity of RST specificity of RST
时间窗: 3-4 months
次要结局
- ease of use effect on antibacterial prescribing(3-4 months)