PharyngitisNCT03099018
Comparison of Two Rapid Antigen Detection Tests for the Detection of Group-A Streptococcal Pharyngitis in Children
An observational study of Pharyngitis, run by University Hospital, Geneva.
Trial summary
Group A streptococcal (GAS) pharyngitis in children represents a frequent diagnostic challenge in pediatric emergency departments, since isolated signs and clinical prediction rules are insufficient to accurately discriminate between GAS and non GAS infections. Read more about this study
- Who is it for?
- Ages 3 to 15 years
- Conditions the study is for
- Pharyngitis
- What is being tested?
- Sofia Strep A FIA
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Nov 2016
- Phase
- Observational
- 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 3 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Children 3 to 15 years old presenting to the PED with pharyngitis and Mc Isaac score ≥ 2
Who may be able to join
- Patient age between 3 and 15 years
- Clinical diagnosis of pharyngitis
- McIsaac score ≥2
Who cannot join
- Antibiotic treatment in the two weeks preceding the consultation
About this study
Group A streptococcal (GAS) pharyngitis in children represents a frequent diagnostic challenge in pediatric emergency departments, since isolated signs and clinical prediction rules are insufficient to accurately discriminate between GAS and non GAS infections. Rapid antigen detection tests (RADTs) therefore remain essential, simple and rapid tools, allowing for rapid GAS identification and prompt antibiotic prescription. However, their sensitivity is not optimal. The aim of the present study is to test the accuracy of a new fluorescent immunoassay (Sofia Strep A FIA) using the optical technology for GAS detection in children 3-15 years old with pharyngitis, compared to a standard RADT, using throat culture as the gold standard (or PCR for discrepant results, i.e. negative culture with any positive RADT).
- Conditions
- Pharyngitis
- Being tested
- Sofia Strep A FIA
- Keywords
- GAS, pharyngitis, children, RADT
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sofia Strep A FIADiagnostic test
Patients who presented with sore throat will be performed throat swab for the new fluorescent immunoasssay (Sofia Strep A FIA), for a standard RADT (Alere Testpack Strep A) and for culture and backup PCR in case of discrepant results.
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of the new Sofia Strep A FIA test in children with pharyngitis
Comparison of the sensitivity and specificity of two rapid tests (Sofia StrepA FIA and Alere Testpack Strep A) using standard throat culture as reference.
Measured: 1 hour
Secondary outcomes (1)
Diagnostic accuracy of the new Sofia Strep A FIA test in children with pharyngitis stratified on the pretest probability of GAS infection (according to McIsaac scores)
sensitivity and specificity of the two tests in relationship to the pretest-probability of GAS infection as measured by the McIsaac score
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study startJun 2014
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharyngitisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Collaborators
- Quidel Corporation
- Responsible party
- Principal investigator, Laurence Lacroix, University Hospital, Geneva
- Investigators
- Laurence Lacroix, MD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03099018
- Sponsor's protocol ID
- 13-248
- Status last verified
- Apr 2017
- First submitted
- 28 Mar 2017
- Last updated
- 17 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Rapid Antigen Detection Tests for the Detection of Group-A Streptococcal Pharyngitis in Children
- ClinicalTrials.gov ID
- NCT03099018
- Acronym / sponsor ID
- 13-248
- Conditions
- Pharyngitis
- Keywords
- GAS, pharyngitis, children, RADT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Collaborators
- Quidel Corporation
- Study start
- Jun 2014 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 4 Apr 2017 (actual)
- 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.
Group A streptococcal (GAS) pharyngitis in children represents a frequent diagnostic challenge in pediatric emergency departments, since isolated signs and clinical prediction rules are insufficient to accurately discriminate between GAS and non GAS infections. Rapid antigen detection tests (RADTs) therefore remain essential, simple and rapid tools, allowing for rapid GAS identification and prompt antibiotic prescription. However, their sensitivity is not optimal. The aim of the present study is to test the accuracy of a new fluorescent immunoassay (Sofia Strep A FIA) using the optical technology for GAS detection in children 3-15 years old with pharyngitis, compared to a standard RADT, using throat culture as the gold standard (or PCR for discrepant results, i.e. negative culture with any positive RADT).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children 3 to 15 years old presenting to the PED with pharyngitis and Mc Isaac score ≥ 2
Key inclusion criteria (3 listed)
- Patient age between 3 and 15 years
- Clinical diagnosis of pharyngitis
- McIsaac score ≥2
Key exclusion criteria (1 listed)
- Antibiotic treatment in the two weeks preceding the consultation
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 |
|---|---|---|
| Sofia Strep A FIAPatients who presented with sore throat will be performed throat swab for the new fluorescent immunoasssay (Sofia Strep A FIA), for a standard RADT (Alere Testpack Strep A) and for culture and backup PCR in case of discrepant results. | Diagnostic test | – |
Primary outcome
Diagnostic accuracy of the new Sofia Strep A FIA test in children with pharyngitis
Time frame: 1 hour
Comparison of the sensitivity and specificity of two rapid tests (Sofia StrepA FIA and Alere Testpack Strep A) using standard throat culture as reference.
1 secondary outcome
Diagnostic accuracy of the new Sofia Strep A FIA test in children with pharyngitis stratified on the pretest probability of GAS infection (according to McIsaac scores)
Time frame: 1 hour
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 17 Apr 2017.
- Individual participant dataSharing planned: No
Related trials for Pharyngitis
Not yet recruitingObservational study
A Multicenter Evaluation of SalivIQ™ Strep A for Detecting Group A Streptococcus From Saliva and Throat Swabs in Patients With Acute Pharyngitis
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Enhanced Telemedicine in Primary Care for Acute Respiratory Tract Infections Study
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Perspectives on Antibiotics and Tracking Symptoms in Children
Urinary Tract Infection, Cellulitis
Not yet recruitingPhase 1
Stopping Strep Throat With Antibodies in Healthy Adults.
Streptococcal Pharyngitis
Not yet recruitingPhase 4
Short Versus Standard Amoxicillin for Pediatric Strep Throat
Group A Streptococcal (GAS) Pharyngitis
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.
Laurence Lacroix, MD principal investigator
University Hospital, Geneva
Questions about this trial
What is this clinical trial studying?
An observational study of Pharyngitis, run by University Hospital, Geneva.
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 3 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 17 Apr 2017. 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?
Diagnostic accuracy of the new Sofia Strep A FIA test in children with pharyngitis (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Apr 2017; AzTrials last refreshed its copy on 31 Oct 2026.