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.

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Key information

Conditions

Streptococcal Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections

Age range

2 year–20 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Northern Virginia Pediatrics

Falls Church, Virginia, 22046, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rapid strep antigen detection test

Diagnostic Test

Pharyngeal swab for rapid antigen detection of streptococcus

Other names: rapid strep

throat culture

Diagnostic Test

Pharyngeal swab for culture for bacteria (specifically streptococcus) presence

Primary outcomes

Rate of false positives and false negatives in rapid antigen testing compared to throat culture

Time frame: 48-72 hours

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.

Sponsors and collaborators

Lead sponsor

Georgetown University

Other

Registry information

Important dates

Study start: 2013
Primary completion: 2018
Study completion: 2018
First posted: Feb 16, 2017
Registry last updated: Jun 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed