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临床试验/NCT02494219
NCT02494219已完成不适用

Comparison of Immunochromatographic Test for Rapid Detection of Group A Streptococcal Antigen With Culture in Pediatric Patients

Hamad Medical Corporation2 个研究点 分布在 1 个国家目标入组 906 人开始时间: 2008年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
906
试验地点
2
主要终点
The ratio of true negative rapid immunochromatographic strep test when compared throat culture

研究概览

简要总结

Comparison of Immunochromatographic Test for rapid detection of group A streptococcal antigen with culture in Pediatric patients.

详细描述

Throat swabbing by two port germ Amines agar (copan) swabs,then the swabs were randomly labeled as swab A and swab B.Swab A was processed for rapid streptococcal test and swab B was processed for culture in Colombia blood agar.All patients were followed up after 48-72 hours with the final culture results that ultimately determined the need to continue or discontinue treatment.

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
1 Year 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • All patients presenting with the possible diagnosis of Bacterial pharyngitis,between 1-14 years of age.

排除标准

  • Patients who received antibiotics within two weeks from presentation

结局指标

主要结局

The ratio of true negative rapid immunochromatographic strep test when compared throat culture

时间窗: upto 48 hours

次要结局

  • The ratio of true positive rapid immunochromatographic strep test when compared to throat culture(upto 48hours)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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