NCT02623985

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2015

Completed
5 days until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 8, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

October 7, 2022

Status Verified

October 1, 2022

Enrollment Period

1 year

First QC Date

November 26, 2015

Last Update Submit

October 6, 2022

Conditions

Pharyngitis

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (3)

Sofia

EXPERIMENTAL

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

Device: Sofia

QuickVue

EXPERIMENTAL

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

Device: QuickVue

Throat swab culture

EXPERIMENTAL

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

Interventions

SofiaDEVICE

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

Also known as: Sofia for rapid test
Sofia
QuickVueDEVICE

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

Also known as: QuickVue for rapid test
QuickVue
Throat swab cultureDEVICE

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

Also known as: throat swab culture for gold standard
Throat swab culture

Eligibility Criteria

Age7 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 26159722BACKGROUND

MeSH Terms

Conditions

Pharyngitis

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

November 26, 2015

First Posted

December 8, 2015

Study Start

December 1, 2015

Primary Completion

December 1, 2016

Study Completion

June 1, 2017

Last Updated

October 7, 2022

Record last verified: 2022-10