Streptococcal Infections Clinical Trial
Official title:
Rapid Strep Testing in Children With Recent Streptococcal Pharyngitis
NCT number | NCT03055728 |
Other study ID # | 2013-0388 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 9, 2013 |
Est. completion date | January 16, 2018 |
Verified date | June 2018 |
Source | Georgetown University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 600 |
Est. completion date | January 16, 2018 |
Est. primary completion date | January 16, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 20 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Northern Virginia Pediatrics | Falls Church | Virginia |
Lead Sponsor | Collaborator |
---|---|
Georgetown University |
United States,
Edmonson MB, Farwell KR. Relationship between the clinical likelihood of group a streptococcal pharyngitis and the sensitivity of a rapid antigen-detection test in a pediatric practice. Pediatrics. 2005 Feb;115(2):280-5. — View Citation
Leung AK, Newman R, Kumar A, Davies HD. Rapid antigen detection testing in diagnosing group A beta-hemolytic streptococcal pharyngitis. Expert Rev Mol Diagn. 2006 Sep;6(5):761-6. Review. — View Citation
Llor C, Calviño O, Hernández S, Crispi S, Pérez-Bauer M, Fernández Y, Martínez T, Gómez FF, Cots JM. Repetition of the rapid antigen test in initially negative supposed streptococcal pharyngitis is not necessary in adults. Int J Clin Pract. 2009 Sep;63(9):1340-4. doi: 10.1111/j.1742-1241.2009.02048.x. — View Citation
McIsaac WJ, White D, Tannenbaum D, Low DE. A clinical score to reduce unnecessary antibiotic use in patients with sore throat. CMAJ. 1998 Jan 13;158(1):75-83. — View Citation
Sheeler RD, Houston MS, Radke S, Dale JC, Adamson SC. Accuracy of rapid strep testing in patients who have had recent streptococcal pharyngitis. J Am Board Fam Pract. 2002 Jul-Aug;15(4):261-5. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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