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

Last updated: April 22, 2024
Sponsor: Centre Hospitalier Intercommunal Creteil
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pharyngitis

Throat And Tonsil Infections

Strep Throat

Treatment

Index test: Abbott ID NOW STREP A 2

Comparator test: Rapid antigen detection test (usual care)

Reference standard test: Composite of culture and PCR-based tests based on a throat swab

Clinical Study ID

NCT05521568
PREDISTREP IX
  • Ages 3-15
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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/ortonsils (erythema with or without exudate) or acute sore throat (even if without localsigns of pharyngeal inflammation)
  • non-opposition of the accompanying parent(s)

Exclusion

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

Total Participants: 800
Treatment Group(s): 3
Primary Treatment: Index test: Abbott ID NOW STREP A 2
Phase:
Study Start date:
January 31, 2023
Estimated Completion Date:
February 28, 2025

Study 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.

Connect with a study center

  • WOLLNER

    Nogent-sur-Marne, 94130
    France

    Site Not Available

  • TOUITOU

    Paris, 75012
    France

    Site Not Available

  • ACTIV

    Saint-Maur-des-Fossés,
    France

    Active - Recruiting

  • Partouche

    Saint-Ouen, 93400
    France

    Site Not Available

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