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Evaluation of Accuracy of Rapid Tests for Group A Beta Hemolytic Streptococci in Out-patients With Sore Throat

Sponsor
Mahidol University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02623985
Collaborator
(none)
400
Enrollment
3
Arms
18
Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate accuracy of rapid tests for group A beta hemolytic streptococci in patients who presented with sore throat at out patient department in Siriraj Hospital.

Condition or Disease Intervention/Treatment Phase
  • Device: Sofia
  • Device: QuickVue
  • Device: Throat swab culture
 Phase 3

Detailed Description

The patients who presented with sore throat at out patient department less than 5 days and age over 6 years old would be enrolled by the primary physicians and the consent forms will be completed by researcher.

The throat swab would be performed by using Sofia, QuickVue rapid tests compare to the gold standard which is a throat swab culture to evaluate the accuracy of the rapid tests.

The sample size for validation of sensitivity and specificity of rapid tests is 358 patients.

The primary outcome is will be evaluated sensitivity and specificity of both rapid tests.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Evaluation of Accuracy of Rapid Tests for Group A Beta Hemolytic Streptococci in Out-patients With Sore Throat From Acute Pharyngitis at Siriraj Hospital
Study Start Date :
Dec 1, 2015
Anticipated Primary Completion Date :
Dec 1, 2016
Anticipated Study Completion Date :
Jun 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sofia

Patients who presented with sore throat will be performed throat swab and sent for Sofia which is rapid test.

Device: Sofia
Patients who presented with sore throat will be performed throat swab and sent for Sofia for rapid test.
Other Names:
  • Sofia for rapid test

    		•
    Experimental: QuickVue

    Patients who presented with sore throat will be performed throat swab and sent for QuickVue which is rapid test.

    Device: QuickVue
    Patients who presented with sore throat will be performed throat swab and sent for QuickVue for rapid test.
    Other Names:
  • QuickVue for rapid test

    		•
    Experimental: Throat swab culture

    Patients who presented with sore throat will be performed throat swab and sent for throat swab culture which is gold standard.

    Device: Throat swab culture
    Patients who presented with sore throat will be performed throat swab and sent for throat swab culture for gold standard.
    Other Names:
  • throat swab culture for gold standard

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Of participants positive for Group A Streptococcus by Sofia rapid test, the percentage who are positive for Group A Streptococcus by Sofia rapid test. [Day 1]

      Establish sensitivity against a gold standard. Report as a percentage of participants with 95% confidence limits.

    2. Of participants positive for Group A Streptococcus by Sofia rapid test, the percentage who are negative for Group A Streptococcus by Sofia rapid test. [Day 1]

      Establish specificity against a gold standard. Report as a percentage of participants with 95% confidence limits.

    3. Of participants positive for Group A Streptococcus by QuickVue rapid test, the percentage who are positive for Group A Streptococcus by QuickVue rapid test. [Day 1]

      Establish sensitivity against a gold standard. Report as a percentage of participants with 95% confidence limits.

    4. Of participants positive for Group A Streptococcus by QuickVue rapid test, the percentage who are negative for Group A Streptococcus by QuickVue rapid test. [Day 1]

      Establish specificity against a gold standard. Report as a percentage of participants with 95% confidence limits.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    7 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients who came with sore throat less than 5 days.
    Exclusion Criteria:
    • No

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Mahidol University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Adhiratha Boonyasiri, Dr., Mahidol University
    ClinicalTrials.gov Identifier:
    NCT02623985
    Other Study ID Numbers:
    • 539-2558-EC1
    First Posted:
    Dec 8, 2015
    Last Update Posted:
    Dec 8, 2015
    Last Verified:
    Dec 1, 2015
    Additional relevant MeSH terms:
    Pharyngitis

    Study Results

    No Results Posted as of Dec 8, 2015