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Rapid Strep Testing in Children With Recent Streptococcal Pharyngitis

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ClinicalTrials.gov Identifier: NCT03055728
Recruitment Status : Completed
First Posted : February 16, 2017
Last Update Posted : June 7, 2018
Sponsor:
Information provided by (Responsible Party):
Georgetown University

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.

Condition or disease Intervention/treatment
Streptococcal Infections 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.


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Study Type : Observational
Actual Enrollment : 600 participants
Observational Model: Other
Time Perspective: Other
Official Title: Rapid Strep Testing in Children With Recent Streptococcal Pharyngitis
Actual Study Start Date : May 9, 2013
Actual Primary Completion Date : January 16, 2018
Actual Study Completion Date : January 16, 2018

Resource links provided by the National Library of Medicine


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 Name: 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 Name: rapid strep

Diagnostic Test: throat culture
Pharyngeal swab for culture for bacteria (specifically streptococcus) presence




Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples Without DNA
Throat swabs of the posterior oropharynx will be tested for rapid antigen test and throat culture.


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03055728


Locations
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United States, Virginia
Northern Virginia Pediatrics
Falls Church, Virginia, United States, 22046
Sponsors and Collaborators
Georgetown University
Investigators
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Principal Investigator: Amin Barakat, MD Georgetown University Hospital

Publications:
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Responsible Party: Georgetown University
ClinicalTrials.gov Identifier: NCT03055728     History of Changes
Other Study ID Numbers: 2013-0388
First Posted: February 16, 2017    Key Record Dates
Last Update Posted: June 7, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Georgetown University:
streptococcal infections
rapid strep testing
rapid antigen detection test

Additional relevant MeSH terms:
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Pharyngitis
Streptococcal Infections
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Gram-Positive Bacterial Infections
Bacterial Infections