Evaluating saliva tests for diagnosing strep throat in children
Diagnostic Accuracy of Rapid Molecular Tests for Group A Streptococcal Pharyngitis Using Saliva Samples: Prospective Multicenter Study in Primary Care
This study is testing if saliva tests can accurately diagnose strep throat in kids aged 3 to 15, to see if they are a simpler and less invasive option than the usual throat swabs.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 800 (estimated) |
| Ages | 3 Years to 15 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Intercommunal Creteil Academic / other |
| Locations | 1 site (Saint-Maur-des-Fossés) |
| Trial ID | NCT05521568 on ClinicalTrials.gov |
What this trial studies
This observational study assesses the diagnostic accuracy of rapid molecular tests for Group A streptococcal pharyngitis using saliva samples in children aged 3-15 years. It compares these new saliva-based tests to standard throat culture and PCR techniques, which are currently used for diagnosis. The aim is to determine if saliva samples can provide a less invasive and equally effective alternative for identifying strep throat, thereby improving patient management in primary care settings.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 3-15 years presenting with symptoms of acute pharyngitis in a primary care setting.
Not a fit: Patients who have received antibiotics within the past 7 days or are already enrolled in the study for the same episode of pharyngitis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to quicker and less invasive testing for strep throat in children, improving treatment decisions.
How similar studies have performed: While traditional throat swab tests are well-established, the use of saliva for rapid molecular testing in this context is a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * children who received antibiotics within 7 days before inclusion * children already enrolled in the study for the same episode of pharyngitis
Where this trial is running
Saint-Maur-des-Fossés
- Activ — Saint-Maur-des-Fossés, France (Recruiting)
Study contacts
- Study coordinator: Jérémie COHEN, MD
- Email: jeremie.cohen@inserm.fr
- Phone: 01 44 49 48 72
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.