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

Recruiting

• Conditions: Streptococcal Pharyngitis

• Registration Number: NCT05521568
• Lead Sponsor: Centre Hospitalier Intercommunal Creteil

Brief 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.

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 Timeline

• Study First Submitted: 2022-08-23
• Study First Submitted QC: 2022-08-26
• Study First Posted: 2022-08-30
• Study Start: 2023-01-31
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-23
• Primary Completion: 2025-01-31
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity of the Abbott ID NOW STREP A 2 rapid molecular test on saliva samples.	Immediatly after the test

Secondary Outcome Measures

Name	Time	Method
Difference in sensitivity between the rapid molecular tests on saliva and the classical rapid antigen detection tests on throat swabs	Immediatly after the test

Trial Locations

Locations (1)

ACTIV; 🇫🇷 Saint-Maur-des-Fossés, France