Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02623985
Recruitment Status : Unknown
Verified December 2015 by Adhiratha Boonyasiri, Mahidol University.
Recruitment status was:  Not yet recruiting
First Posted : December 8, 2015
Last Update Posted : December 8, 2015
Sponsor:
Information provided by (Responsible Party):
Adhiratha Boonyasiri, Mahidol University

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
Pharyngitis 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : December 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sore Throat

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 Name: 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 Name: 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 Name: throat swab culture for gold standard




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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: Day 1 ]
    Establish specificity against a gold standard. Report as a percentage of participants with 95% confidence limits.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   7 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who came with sore throat less than 5 days.

Exclusion Criteria:

  • No

Publications:
Layout table for additonal information
Responsible Party: Adhiratha Boonyasiri, Dr., Mahidol University
ClinicalTrials.gov Identifier: NCT02623985    
Other Study ID Numbers: 539-2558-EC1
First Posted: December 8, 2015    Key Record Dates
Last Update Posted: December 8, 2015
Last Verified: December 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases