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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

Tracking Information
First Submitted Date February 9, 2017
First Posted Date February 16, 2017
Last Update Posted Date June 7, 2018
Actual Study Start Date May 9, 2013
Actual Primary Completion Date January 16, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 14, 2017)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03055728 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Rapid Strep Testing in Children With Recent Streptococcal Pharyngitis
Official Title Rapid Strep Testing in Children With Recent Streptococcal Pharyngitis
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.
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
Study Design Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Throat swabs of the posterior oropharynx will be tested for rapid antigen test and throat culture.
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.

Condition Streptococcal Infections
Intervention
  • 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
Study Groups/Cohorts
  • 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.
    Interventions:
    • 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.
    Interventions:
    • Diagnostic Test: Rapid strep antigen detection test
    • Diagnostic Test: throat culture
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 14, 2017)
600
Original Estimated Enrollment Same as current
Actual Study Completion Date January 16, 2018
Actual Primary Completion Date January 16, 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 2 Years to 20 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03055728
Other Study ID Numbers 2013-0388
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Georgetown University
Study Sponsor Georgetown University
Collaborators Not Provided
Investigators
Principal Investigator: Amin Barakat, MD Georgetown University Hospital
PRS Account Georgetown University
Verification Date June 2018