Streptococcal Infections Clinical Trial
Official title:
Rapid Strep Testing in Children With Recent Streptococcal Pharyngitis
The purpose of this study is to determine if the rapid antigen detection test for Group A streptococcal pharyngitis diagnosis might yield higher rates of false positive results in patients who have been treated for GAS pharyngitis within 28 days of the test.
Strep pharyngitis, or strep throat, is a common infection afflicting children, aged 2 and
above. Testing for strep pharyngitis consists of a rapid test and/or a throat culture.
However, it has been observed that rapid testing may not be accurate in children with a
recent history of strep pharyngitis. Therefore, this study aims to determine the accuracy of
rapid strep testing in children who are presenting with symptoms of strep throat, who also
have a recent history of and treatment for strep pharyngitis. By demonstrating an inaccuracy
in rapid strep testing in patients with a recent history of strep pharyngitis, unnecessary
testing and antibiotic use may be decreased, thereby reducing costs, overuse of antibiotics,
and antibiotic resistance.
The participants in the study will include 600 children, aged 2 to 20 years old, selected
from a private practice in Northern Virginia who present to the practice with signs or
symptoms suggestive of acute pharyngitis. Subjects are children who are presenting with signs
and symptoms suggestive of acute pharyngitis by the Centor criteria, including sore throat,
fever, abdominal pain and cervical lymphadenitis. Any child with above presenting symptoms
who is to undergo Streptococcus rapid antigen testing will be recruited to participate in the
study.
A letter of consent will be provided to the parents and guardians of the involved child,
stating that the study will be voluntary and confidential, and that all results will be kept
in a safe environment.
Investigators will be testing the difference between two proportions, the false positive rate
in previously treated compared to those not treated.
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