PharyngitisNCT02623985
Evaluation of Accuracy of Rapid Tests for Group A Beta Hemolytic Streptococci in Out-patients With Sore Throat
A study testing Sofia, QuickVue and Throat swab culture in people with Pharyngitis, run by Mahidol University.
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. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Pharyngitis
- What is being tested?
- Sofia, QuickVue and Throat swab culture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who came with sore throat less than 5 days.
Who cannot join
- No
About this study
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
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.
Read the 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.
- Conditions
- Pharyngitis
- Being tested
- Sofia, QuickVue, Throat swab culture
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SofiaDevice
Also called Sofia for rapid test
Patients who presented with sore throat will be performed throat swab and sent for Sofia for rapid test.
QuickVueDevice
Also called QuickVue for rapid test
Patients who presented with sore throat will be performed throat swab and sent for QuickVue for rapid test.
Throat swab cultureDevice
Also called throat swab culture for gold standard
Patients who presented with sore throat will be performed throat swab and sent for throat swab culture for gold standard.
| Study group | Role | What they receive |
|---|---|---|
| Sofia | Experimental | Patients who presented with sore throat will be performed throat swab and sent for Sofia which is rapid test. Receives: Device: Sofia |
| QuickVue | Experimental | Patients who presented with sore throat will be performed throat swab and sent for QuickVue which is rapid test. Receives: 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. Receives: Device: Throat swab culture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionDec 2016
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PharyngitisStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adhiratha Boonyasiri, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02623985
- Sponsor's protocol ID
- 539-2558-EC1
- Status last verified
- Oct 2022
- First submitted
- 26 Nov 2015
- Last updated
- 7 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26159722
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02623985
- Acronym / sponsor ID
- 539-2558-EC1
- Conditions
- Pharyngitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 8 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sofia | Experimental | Device: SofiaPatients who presented with sore throat will be performed throat swab and sent for Sofia which is rapid test. |
| QuickVue | Experimental | Device: QuickVuePatients who presented with sore throat will be performed throat swab and sent for QuickVue which is rapid test. |
| Throat swab culture | Experimental | Device: Throat swab culturePatients who presented with sore throat will be performed throat swab and sent for throat swab culture which is gold standard. |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who came with sore throat less than 5 days.
Key exclusion criteria (1 listed)
- No
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SofiaAlso: Sofia for rapid testPatients who presented with sore throat will be performed throat swab and sent for Sofia for rapid test. | Device | Sofia |
| QuickVueAlso: QuickVue for rapid testPatients who presented with sore throat will be performed throat swab and sent for QuickVue for rapid test. | Device | QuickVue |
| Throat swab cultureAlso: throat swab culture for gold standardPatients who presented with sore throat will be performed throat swab and sent for throat swab culture for gold standard. | Device | Throat swab culture |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2022.
- Background: PubMed 26159722Plainvert 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Sofia, QuickVue and Throat swab culture in people with Pharyngitis, run by Mahidol University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02623985, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2022.