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

Pharyngitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02623985
• Other study ID #: 539-2558-EC1
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: June 2017

Study information

• Verified date: October 2022
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: June 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• No

Related Conditions & MeSH terms

• Pharyngitis

Intervention

Device:
• Sofia
Patients who presented with sore throat will be performed throat swab and sent for Sofia for rapid test.
• QuickVue
Patients who presented with sore throat will be performed throat swab and sent for QuickVue for rapid test.
• Throat swab culture
Patients who presented with sore throat will be performed throat swab and sent for throat swab culture for gold standard.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

References & Publications (1)

Plainvert C, Duquesne I, Touak G, Dmytruk N, Poyart C. In vitro evaluation and comparison of 5 rapid antigen detection tests for the diagnosis of beta-hemolytic group A streptococcal pharyngitis. Diagn Microbiol Infect Dis. 2015 Oct;83(2):105-11. doi: 10.1016/j.diagmicrobio.2015.06.012. Epub 2015 Jun 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Of participants positive for Group A Streptococcus by Sofia rapid test, the percentage who are positive for Group A Streptococcus by Sofia rapid test.	Establish sensitivity against a gold standard. Report as a percentage of participants with 95% confidence limits.	Day 1
Primary	Of participants positive for Group A Streptococcus by Sofia rapid test, the percentage who are negative for Group A Streptococcus by Sofia rapid test.	Establish specificity against a gold standard. Report as a percentage of participants with 95% confidence limits.	Day 1
Primary	Of participants positive for Group A Streptococcus by QuickVue rapid test, the percentage who are positive for Group A Streptococcus by QuickVue rapid test.	Establish sensitivity against a gold standard. Report as a percentage of participants with 95% confidence limits.	Day 1
Primary	Of participants positive for Group A Streptococcus by QuickVue rapid test, the percentage who are negative for Group A Streptococcus by QuickVue rapid test.	Establish specificity against a gold standard. Report as a percentage of participants with 95% confidence limits.	Day 1