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临床试验/NCT04256694
NCT04256694Unknown不适用

Rapid Antigen Test Results for Group A Streptococcus in Healthy Adults

Kendall Healthcare Group, Ltd.1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年2月5日最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
% Positive Rapid Antigen Strep Tests

研究概览

简要总结

This is a prospective study seeks to determine how often a rapid antigens test for group A streptococcus is positive in healthy adults

详细描述

The Unites States recommends the use of rapid antigen tests, but a number of other countries do not, citing a high prevalence of streptococcal carriers and only moderate sensitivity of rapid antigen tests [1]. Indeed, to fully understand when rapid antigen tests should be used, we need to know the streptococcal carrier rate for adults in the United States. Although there is a fair amount of data in this regard for children [2,3], the only study to report this value for adults was from over 20 years ago and was from Sweden [4]. That studied reported a Group A Streptococcus (GAS) carrier rate of 2.4-3.7% in healthy adults.

Given how many patients seek medical care for sore throats that may potentially be streptococcal pharyngitis, the investigators believe more data about the GAS carrier rate and the rate of false positive rapid antigen tests is necessary. Thus, the investigators propose a prospective study to evaluate the rate of positive rapid antigen tests in healthy adult patients in our community.

The investigators will perform rapid antigen tests for GAS on healthy adult subjects without any symptoms. Consenting patients will fill out a brief data collection form about their medical history, and an investigator will perform a rapid antigen throat swab to assess for GAS. The results of the rapid antigen test will be recorded, and a logistic regression analysis will be performed to determine if certain factors within the subject's medical history are predictive of positive rapid strep tests.

研究设计

研究类型
Observational
观察模型
Cohort
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

入选标准

  • Any person at least 18 years old

排除标准

  • prisoners
  • currently taking antibiotics
  • any acute symptoms

结局指标

主要结局

% Positive Rapid Antigen Strep Tests

时间窗: The throat will be swabbed, and the swab will be immediately analyzed. The results are available after five minutes.

% of positive rapid antigen strep tests amongst all volunteers

次要结局

  • Predictors of Positive Strep Tests(After enrollment of all subjects, a logistic regression analysis will be performed.)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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