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.

Study Overview

• Status: Completed
• Conditions: Streptococcal Infections
• Intervention / Treatment: Diagnostic test: Rapid strep antigen detection test; Diagnostic test: throat culture

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.

• Study Type: Observational
• Enrollment (Actual): 600

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Falls Church, Virginia, United States, 22046
      • Northern Virginia Pediatrics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 20 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1 / Study Group; 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; Pharyngeal swab for rapid antigen detection of streptococcus; Other Names: rapid strep; Diagnostic test: throat culture; Pharyngeal swab for culture for bacteria (specifically streptococcus) presence
Group 2 / Control Group; 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; Pharyngeal swab for rapid antigen detection of streptococcus; Other Names: rapid strep; Diagnostic test: throat culture; Pharyngeal swab for culture for bacteria (specifically streptococcus) presence

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Georgetown University
• Investigators: Principal Investigator: Amin Barakat, MD, Georgetown University Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2013
• Primary Completion (Actual): January 16, 2018
• Study Completion (Actual): January 16, 2018

Study Registration Dates

• First Submitted: February 9, 2017
• First Submitted That Met QC Criteria: February 14, 2017
• First Posted (Actual): February 16, 2017

Study Record Updates

• Last Update Posted (Actual): June 7, 2018
• Last Update Submitted That Met QC Criteria: June 5, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: streptococcal infections; rapid strep testing; rapid antigen detection test
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Pharyngitis; Streptococcal Infections
• Other Study ID Numbers: 2013-0388

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No