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Search / Trial NCT05521568

Diagnostic Accuracy of Rapid Molecular Tests for Group A Streptococcal Pharyngitis Using Saliva Samples

Launched by CENTRE HOSPITALIER INTERCOMMUNAL CRETEIL · Aug 26, 2022

Trial Information

Current as of July 01, 2025

Recruiting

Keywords

Sore Throat, Rapid Tests, Molecular Tests, Saliva, Sensitivity, Specificity

ClinConnect Summary

This clinical trial is looking at how well a new rapid test can diagnose strep throat in children using saliva samples. Strep throat, or streptococcal pharyngitis, is an infection that causes a sore throat and is common in kids aged 3 to 15 years. The study aims to compare this quick saliva test to the traditional methods that involve taking a throat culture or other lab tests. By doing this, researchers hope to find a faster and easier way to diagnose strep throat in children who visit their primary care doctors with a sore throat.

To qualify for the study, children need to be between 3 and 15 years old and must have a sore throat or throat inflammation. They should be seen in a primary care setting, like a family doctor or pediatrician, and their parents must agree to participate. However, children who have taken antibiotics in the past week or are already part of the study for the same sore throat episode cannot join. If eligible, participants can expect to provide a saliva sample, which will help in determining how accurately the new test can identify strep throat compared to standard testing methods.

Gender

ALL

Eligibility 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

About Centre Hospitalier Intercommunal Creteil

Centre Hospitalier Intercommunal Créteil (CHIC) is a leading healthcare institution in the Val-de-Marne department of France, dedicated to delivering high-quality medical care and advancing clinical research. As a prominent clinical trial sponsor, CHIC collaborates with healthcare professionals and academic institutions to facilitate innovative research initiatives aimed at improving patient outcomes. The center is committed to adhering to rigorous ethical standards and regulatory guidelines, ensuring the safety and efficacy of interventions tested within its clinical trials. CHIC’s multidisciplinary approach fosters an environment of collaboration and excellence, positioning it as a key player in the advancement of medical knowledge and therapeutic options.

Locations

Paris, , France

Saint Ouen, , France

Nogent Sur Marne, , France

Paris, , France

Saint Maur Des Fossés, , France

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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