Clinical trial NCT05521568: Diagnostic Accuracy of Rapid Molecular Tests for Group A Streptococcal Pharyngitis Using Saliva Samples
Official title: Diagnostic Accuracy of Rapid Molecular Tests for Group A Streptococcal Pharyngitis Using Saliva Samples: Prospective Multicenter Study in Primary Care
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Streptococcal Pharyngitis
Keywords: sore throat, rapid tests, molecular tests, saliva, sensitivity, specificity
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
Collaborators: name: Hôpital Necker-Enfants Malades
name: University Hospital, Paris
name: Groupe Hospitalier Diaconesses Croix Saint-Simon
name: Association Clinique Thérapeutique Infantile du val de Marne
First posted: 2022-08-30
Enrollment: 800
Sex: ALL
Minimum age (years): 3
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children (3 to 15 years) with acute pharyngitis in primary care

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.

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

Primary outcomes:
measure: Sensitivity of the Abbott ID NOW STREP A 2 rapid molecular test on saliva samples.
timeFrame: Immediatly after the test
Secondary outcomes:
measure: Difference in sensitivity between the rapid molecular tests on saliva and the classical rapid antigen detection tests on throat swabs
timeFrame: Immediatly after the test
Other outcomes:
measure: Variability in sensitivity and specificity of rapid molecular tests on saliva according to the McIsaac score (modified Centor score)
timeFrame: Immediatly after the test
measure: Time needed to perform the rapid molecular test on saliva and obtain the results
timeFrame: Immediatly after the test
measure: Satisfaction of the physician, the child, and the accompanying parent(s) withe a questionnaire
timeFrame: Through study completion, an average of 1,5 year
measure: Main reasons for not performing rapid tests among primary care practitioners
timeFrame: Through study completion, an average of 1,5 year
Locations:
city: Saint-Maur-des-Fossés
country: France
facility: ACTIV
Study officials:
References: