Streptococcal PharyngitisNCT05521568
Diagnostic Accuracy of Rapid Molecular Tests for Group A Streptococcal Pharyngitis Using Saliva Samples
An observational study of Streptococcal Pharyngitis, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
Trial summary
Observational study evaluating the diagnostic accuracy of rapid point-of-care molecular Group A strep diagnostic tests in saliva as compared to standard culture- and PCR-based techniques for the management of children aged 3-15 years of age presenting with sore throat to primary care. Read more about this study
- Who is it for?
- Ages 3 to 15 years
- Conditions the study is for
- Streptococcal Pharyngitis
- What is being tested?
- Index test: Abbott ID NOW STREP A 2 and Reference standard test: Composite of culture and PCR-based tests based on a throat swab
- How many people
- 800 participants
- Where
- 1 siteFrance
- Study dates
- 31 Jan 2023to 28 Feb 2025
- 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) with acute pharyngitis in primary care
Who may be able to join
- children 3-15 years
- seen in primary care (general practitioner or primary care pediatrician)
- with a diagnosis of acute pharyngitis defined as an inflammation of the pharynx and/or tonsils (erythema with or without exudate) or acute sore throat (even if without local signs of pharyngeal inflammation)
- non-opposition of the accompanying parent(s)
Who cannot join
- children who received antibiotics within 7 days before inclusion
- children already enrolled in the study for the same episode of pharyngitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Accuracy of Rapid Molecular Tests for Group A Streptococcal Pharyngitis Using Saliva Samples: Prospective Multicenter Study in Primary Care
Observational study evaluating the diagnostic accuracy of rapid point-of-care molecular Group A strep diagnostic tests in saliva as compared to standard culture- and PCR-based techniques for the management of children aged 3-15 years of age presenting with sore throat to primary care.
Read the detailed description
Group A streptococcus (GAS) is found in 20% to 40% of cases of childhood pharyngitis; the remaining cases are viral. Streptococcal pharyngitis ('strep throat') deserves antibiotics, while these are not indicated in viral cases. Because signs and symptoms of streptococcal and viral cases overlap, most guidelines recommend relying on a diagnostic test to identify Group A streptococcus to select who should receive antibiotics. In most settings, the first-line test to detect Group A Streptococcus is a rapid antigen detection test based on a throat swab, and the reference standard to identify streptococcal cases is throat culture. Recently, new rapid tests were developed. They use molecular techniques, such as rapid PCRs or LAMP, based on throat swabs. We hypothesize that these new molecular tests are sensitive enough to be performed on saliva swabs instead of throat swabs. Collecting saliva is less invasive and could be done by personnel with limited training.
- Conditions
- Streptococcal Pharyngitis
- Being tested
- Index test: Abbott ID NOW STREP A 2, Reference standard test: Composite of culture and PCR-based tests based on a throat swab, Comparator test: Rapid antigen detection test (usual care)
- Keywords
- sore throat, rapid tests, molecular tests, saliva, sensitivity, specificity
- Medical subject headings
- Pharyngitis, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Index test: Abbott ID NOW STREP A 2Diagnostic test
The test under evaluation ('index test') is the rapid molecular test for Group A streptococcus Abbott ID NOW STREP A 2 (performed on saliva samples instead of throat swabs). This test was chosen because of its ease of use and several previous evaluations showing high diagnostic accuracy on throat swabs. The test gives a result after 2 to 6 minutes and will be performed by primary care practitioners participating in the study, in their office, using salivary swabs instead of throat swabs. Investigators will receive one session of specific training prior to the study. Saliva samples will be collected using the cotton swab that comes within the test packages. Index test results will not be used for patient management. Clinicians performing the rapid saliva test will not be blinded to clinical information.
Reference standard test: Composite of culture and PCR-based tests based on a throat swabDiagnostic test
Throat samples will be obtained by use of a double-swab collection-transportation system :
- Swab #1 will be used to perform the rapid antigen detection test (see below)
- Swab #2 will be held at ambient temperature and sent within 72 hours to Robert Debre Hospital microbiology laboratory. Throat swabs will be used to perform throat cultures using standard techniques (PMID: 22768060). Throat swabs will also be used to perform a PCR specific for Group A streptococcus (PMID: 23465407). Samples with a positive culture and/or a positive PCR test result will be classified as reference-standard-positives. Samples with a negative culture and a negative PCR will be classified as reference-standard-negatives. Investigators will be blinded to clinical data, including the result of the rapid antigen detection test and the rapid saliva test.
Comparator test: Rapid antigen detection test (usual care)Diagnostic test
As per usual care, all children will undergo a rapid antigen detection test (StreptAtest, Biosynex), using Swab#1 (see above). This rapid antigen detection test is the one used in France and is the only commercial kit that is officially recommended by the National Health Insurance system. It detects Lancefield's Group A antigen, which is specific to Group A Streptococcus. The test will be performed by investigators, during consultation time. Clinicians performing the rapid antigen detection test will not be blinded to clinical information.
| Study group | Role | What they receive |
|---|---|---|
| Index test : Abbott ID NOW STREP A 2 | Not described Receives: Diagnostic Test: Index test: Abbott ID NOW STREP A 2 | |
| Reference standard test : Composite of culture and PCR-based tests based on a throat swab | Not described Receives: Diagnostic Test: Reference standard test: Composite of culture and PCR-based tests based on a throat swab | |
| Comparator test : Rapid antigen detection test (usual care) | Not described Receives: Diagnostic Test: Comparator test: Rapid antigen detection test (usual care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of the Abbott ID NOW STREP A 2 rapid molecular test on saliva samples.
Measured: Immediatly after the test
Secondary outcomes (1)
Difference in sensitivity between the rapid molecular tests on saliva and the classical rapid antigen detection tests on throat swabs
Measured: Immediatly after the test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start31 Jan 2023
- Primary completion31 Jan 2025
- Study completion28 Feb 2025
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 Streptococcal 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Collaborators
- Hôpital Necker-Enfants Malades, University Hospital, Paris, Groupe Hospitalier Diaconesses Croix Saint-Simon, Association Clinique Thérapeutique Infantile du val de Marne
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05521568
- Sponsor's protocol ID
- PREDISTREP IX
- Status last verified
- Sep 2025
- First submitted
- 23 Aug 2022
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Touitou R, Bidet P, Dubois C, Partouche H, Bonacorsi S, Jung C, Cohen R, Levy C, Cohen JF. Diagnostic accuracy of a rapid nucleic acid test for group A streptococcal pharyngitis using saliva samples: protocol for a prospective multicenter study in primary care. Diagn Progn Res. 2023 Jul 13;7(1):13. doi: 10.1186/s41512-023-00150-4.
PubMed 37443047
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Rapid Molecular Tests for Group A Streptococcal Pharyngitis Using Saliva Samples: Prospective Multicenter Study in Primary Care
- ClinicalTrials.gov ID
- NCT05521568
- Acronym / sponsor ID
- PREDISTREP IX
- Conditions
- Streptococcal Pharyngitis
- Keywords
- sore throat, rapid tests, molecular tests, saliva, sensitivity, specificity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Collaborators
- Hôpital Necker-Enfants Malades, University Hospital, Paris, Groupe Hospitalier Diaconesses Croix Saint-Simon, Association Clinique Thérapeutique Infantile du val de Marne
- Study start
- 31 Jan 2023 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 30 Aug 2022 (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.
Observational study evaluating the diagnostic accuracy of rapid point-of-care molecular Group A strep diagnostic tests in saliva as compared to standard culture- and PCR-based techniques for the management of children aged 3-15 years of age presenting with sore throat to primary care.
Detailed description
Group A streptococcus (GAS) is found in 20% to 40% of cases of childhood pharyngitis; the remaining cases are viral. Streptococcal pharyngitis ('strep throat') deserves antibiotics, while these are not indicated in viral cases. Because signs and symptoms of streptococcal and viral cases overlap, most guidelines recommend relying on a diagnostic test to identify Group A streptococcus to select who should receive antibiotics. In most settings, the first-line test to detect Group A Streptococcus is a rapid antigen detection test based on a throat swab, and the reference standard to identify streptococcal cases is throat culture. Recently, new rapid tests were developed. They use molecular techniques, such as rapid PCRs or LAMP, based on throat swabs. We hypothesize that these new molecular tests are sensitive enough to be performed on saliva swabs instead of throat swabs. Collecting saliva is less invasive and could be done by personnel with limited training.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Index test : Abbott ID NOW STREP A 2 | – | Diagnostic Test: Index test: Abbott ID NOW STREP A 2 |
| Reference standard test : Composite of culture and PCR-based tests based on a throat swab | – | Diagnostic Test: Reference standard test: Composite of culture and PCR-based tests based on a throat swab |
| Comparator test : Rapid antigen detection test (usual care) | – | Diagnostic Test: Comparator test: Rapid antigen detection test (usual care) |
Who may qualify
- Ages
- 3 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children (3 to 15 years) with acute pharyngitis in primary care
Key inclusion criteria (4 listed)
- children 3-15 years
- seen in primary care (general practitioner or primary care pediatrician)
- with a diagnosis of acute pharyngitis defined as an inflammation of the pharynx and/or tonsils (erythema with or without exudate) or acute sore throat (even if without local signs of pharyngeal inflammation)
- non-opposition of the accompanying parent(s)
Key exclusion criteria (2 listed)
- children who received antibiotics within 7 days before inclusion
- children already enrolled in the study for the same episode of pharyngitis
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 |
|---|---|---|
| Index test: Abbott ID NOW STREP A 2The test under evaluation ('index test') is the rapid molecular test for Group A streptococcus Abbott ID NOW STREP A 2 (performed on saliva samples instead of throat swabs). This test was chosen because of its ease of use and several previous evaluations showing high diagnostic accuracy on throat swabs. The test gives a result after 2 to 6 minutes and will be performed by primary care practitioners participating in the study, in their office, using salivary swabs instead of throat swabs. Investigators will receive one session of specific training prior to the study. Saliva samples will be collected using the cotton swab that comes within the test packages. Index test results will not be used for patient management. Clinicians performing the rapid saliva test will not be blinded to clinical information. | Diagnostic test | Index test : Abbott ID NOW STREP A 2 |
| Reference standard test: Composite of culture and PCR-based tests based on a throat swabThroat samples will be obtained by use of a double-swab collection-transportation system : * Swab #1 will be used to perform the rapid antigen detection test (see below) * Swab #2 will be held at ambient temperature and sent within 72 hours to Robert Debre Hospital microbiology laboratory. Throat swabs will be used to perform throat cultures using standard techniques (PMID: 22768060). Throat swabs will also be used to perform a PCR specific for Group A streptococcus (PMID: 23465407). Samples with a positive culture and/or a positive PCR test result will be classified as reference-standard-positives. Samples with a negative culture and a negative PCR will be classified as reference-standard-negatives. Investigators will be blinded to clinical data, including the result of the rapid antigen detection test and the rapid saliva test. | Diagnostic test | Reference standard test : Composite of culture and PCR-based tests based on a throat swab |
| Comparator test: Rapid antigen detection test (usual care)As per usual care, all children will undergo a rapid antigen detection test (StreptAtest, Biosynex), using Swab#1 (see above). This rapid antigen detection test is the one used in France and is the only commercial kit that is officially recommended by the National Health Insurance system. It detects Lancefield's Group A antigen, which is specific to Group A Streptococcus. The test will be performed by investigators, during consultation time. Clinicians performing the rapid antigen detection test will not be blinded to clinical information. | Diagnostic test | Comparator test : Rapid antigen detection test (usual care) |
Primary outcome
Sensitivity of the Abbott ID NOW STREP A 2 rapid molecular test on saliva samples.
Time frame: Immediatly after the test
1 secondary outcome
Difference in sensitivity between the rapid molecular tests on saliva and the classical rapid antigen detection tests on throat swabs
Time frame: Immediatly after the test
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 9 Sep 2025.
- Derived from this study: PubMed 37443047Touitou R, Bidet P, Dubois C, Partouche H, Bonacorsi S, Jung C, Cohen R, Levy C, Cohen JF. Diagnostic accuracy of a rapid nucleic acid test for group A streptococcal pharyngitis using saliva samples: protocol for a prospective multicenter study in primary care. Diagn Progn Res. 2023 Jul 13;7(1):13. doi: 10.1186/s41512-023-00150-4.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Streptococcal Pharyngitis, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
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 4 inclusion and 2 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 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Sensitivity of the Abbott ID NOW STREP A 2 rapid molecular test on saliva samples. (time frame: Immediatly after the test). 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 NCT05521568, 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 9 Sep 2025.