An observational study in Strept Throat, sponsored by Kendall Healthcare Group, Ltd.. Status unknown at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-03.
Sponsored by Kendall Healthcare Group, Ltd. · Observational
This is a prospective study seeks to determine how often a rapid antigens test for group A streptococcus is positive in healthy adults
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.
Kendall Healthcare Group, Ltd. is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Healthy volunteers, primarily from subjects known to the investigators.
Exclusion Criteria:
Diagnostic Test: Rapid Antigen Test for Group A Streptococcus
Rapid strep tests will be performed by throat swab of healthy adult volunteers.
% Positive Rapid Antigen Strep Tests
% of positive rapid antigen strep tests amongst all volunteers
Time frame: The throat will be swabbed, and the swab will be immediately analyzed. The results are available after five minutes.
Predictors of Positive Strep Tests
Logistic regression analysis will assess if any of the following are significant predictors of positive strep tests: age, gender, race/ethnicity, chronic medical problems, whether or not the patient has had antibiotics within last month, whether or not they have a history of strep throat, and whether or not they are a medical student or healthcare professional.
Time frame: After enrollment of all subjects, a logistic regression analysis will be performed.
Plan to share: Undecided
This study is status unknown, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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Kendall Healthcare Group, Ltd.