Rapid Strep Testing in Children With Recent Streptococcal Pharyngitis

Streptococcal Infections Clinical Trial

Official title:

Rapid Strep Testing in Children With Recent Streptococcal Pharyngitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03055728
• Other study ID #: 2013-0388
• Status: Completed
• Start date: May 9, 2013
• Est. completion date: January 16, 2018

Study information

• Verified date: June 2018
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Pharyngitis
• Streptococcal Infections

Intervention

Diagnostic Test:
• Rapid strep antigen detection test
Pharyngeal swab for rapid antigen detection of streptococcus
• throat culture
Pharyngeal swab for culture for bacteria (specifically streptococcus) presence

Locations

Country	Name	City	State
United States	Northern Virginia Pediatrics	Falls Church	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Georgetown University

Country where clinical trial is conducted

United States, 

References & Publications (5)

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

Outcome

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