Rapid Strep Testing in Children With Recent Streptococcal Pharyngitis

NCT03055728 | Completed

• 1 other identifier: 2013-0388
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Streptococcal Infections

Keywords

streptococcal infections; rapid strep testing; rapid antigen detection test

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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; Diagnostic Test: throat culture

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; Diagnostic Test: throat culture

Interventions

Rapid strep antigen detection test DIAGNOSTIC_TEST

Pharyngeal swab for rapid antigen detection of streptococcus

Also known as: rapid strep

Group 1 / Study Group; Group 2 / Control Group

throat culture DIAGNOSTIC_TEST

Pharyngeal swab for culture for bacteria (specifically streptococcus) presence

Group 1 / Study Group; Group 2 / Control Group

Eligibility Criteria

• Age: 2 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• years old
• Current signs and symptoms suggestive of acute pharyngitis, including sore throat, fever, abdominal pain and cervical lymphadenitis.

You may not qualify if:

• 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

Sponsors & Collaborators

• Georgetown University: lead

Study Sites (1)

Northern Virginia Pediatrics

Falls Church, Virginia, 22046, United States

Location

Related Publications (5)

• 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.

  PMID: 12150457 BACKGROUND

• 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.

  PMID: 15687433 BACKGROUND

• 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.

  PMID: 9475915 BACKGROUND

• 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.

  PMID: 19691618 BACKGROUND

• 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.

  PMID: 17009909 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Throat swabs of the posterior oropharynx will be tested for rapid antigen test and throat culture.

MeSH Terms

Conditions

Streptococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Amin Barakat, MD

  Georgetown University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2017
• First Posted: February 16, 2017
• Study Start: May 9, 2013
• Primary Completion: January 16, 2018
• Study Completion: January 16, 2018
• Last Updated: June 7, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)