Rapid Strep Testing in Children With Recent Streptococcal Pharyngitis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Rapid Strep Testing in Children With Recent Streptococcal Pharyngitis

Conditions
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Streptococcal Infections

Intervention / Treatment
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* Diagnostic Test: Rapid strep antigen detection test
* Diagnostic Test: throat culture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 2-20 years old Current signs and symptoms suggestive of acute pharyngitis, including sore throat, fever, abdominal pain and cervical lymphadenitis. Exclusion Criteria: Potential subjects who have been treated with less than 10 days of antibiotic therapy Patients who report non-compliance with previous antibiotic therapy Patients who have already been included in the study and children with evidence of GAS carrier status

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1 / Study Group<br>Subjects presenting with signs or symptoms of acute pharyngitis, with a history of culture-proven GAS infection and subsequent 10-day antibiotic treatment within the preceding 28 days. Subjects will have a rapid strep antigen detection test and a throat culture to determine presence of strep. | Diagnostic Test: Rapid strep antigen detection test<br>* Pharyngeal swab for rapid antigen detection of streptococcus<br>* Other names: rapid strep;Diagnostic Test: throat culture<br>* Pharyngeal swab for culture for bacteria (specifically streptococcus) presence<br>|
| Group 2 / Control Group<br>Subjects presenting with signs or symptoms of acute pharyngitis, without a recent history of GAS infection. Subjects will have a rapid strep antigen detection test and a throat culture to determine presence of strep. | Diagnostic Test: Rapid strep antigen detection test<br>* Pharyngeal swab for rapid antigen detection of streptococcus<br>* Other names: rapid strep;Diagnostic Test: throat culture<br>* Pharyngeal swab for culture for bacteria (specifically streptococcus) presence<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of false positives and false negatives in rapid antigen testing compared to throat culture | The primary objective is to use rapid antigen test results to compare the sensitivity and specificity of rapid antigen testing in children with symptoms of pharyngitis with and without a recent history of Group A streptococcus pharyngitis. | 48-72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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streptococcal infections, rapid strep testing, rapid antigen detection test