Clinical trial NCT03055728: Rapid Strep Testing in Children With Recent Streptococcal Pharyngitis
Official title: Rapid Strep Testing in Children With Recent Streptococcal Pharyngitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Streptococcal Infections
Keywords: streptococcal infections
rapid strep testing
rapid antigen detection test
Lead sponsor: Georgetown University
Sponsor class: OTHER
First posted: 2017-02-16
Enrollment: 600
Sex: ALL
Minimum age (years): 2
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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 will be excluded.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of false positives and false negatives in rapid antigen testing compared to throat culture
timeFrame: 48-72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Falls Church
country: United States
facility: Northern Virginia Pediatrics
state: Virginia
Study officials:
affiliation: Georgetown University Hospital
name: Amin Barakat, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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. doi: 10.1542/peds.2004-0907.
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.
citation: Llor C, Calvino O, Hernandez S, Crispi S, Perez-Bauer M, Fernandez Y, Martinez T, Gomez 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.
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. doi: 10.1586/14737159.6.5.761.