Pharyngitis due to group A Streptococcus infection Infections and Infestations
Conditions
Interventions
A primary care site will be selected based on patient population (pediatric) and workflow. The site will execute the standard-of-care Strep A rapid antigen detection test (RADT) with bacterial culture
Sponsors
Roche Molecular Systems Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 3–18 years 2. Clinical signs and symptoms of GAS pharyngitis, defined as the presence of sore throat and at least one other symptom (redness of the posterior pharyngeal wall, pharyngeal or tonsillar exudate, tonsillar swelling, tender cervical lymphadenopathy, and/or fever >100°F)
Exclusion criteria
Exclusion criteria: Treated with antibiotics currently or within the previous 7 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic test results will be recorded by the site staff at the time of testing for POC tests and weekly for laboratory-based tests. The overall sensitivity, specificity, and percentage agreement between the different testing methods and the respective 95% CIs (via Clopper–Pearson, exact) will be calculated by using the laboratory-based Quidel Solana GAS NAAT test as the reference method. All discordant results will be adjudicated with bidirectional sequencing. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Anti-infective prescriptions assessed using the patient's electronic medical record at time of first visit and after the bacterial culture result is available 2. Additional tests ordered, assessed using the patient's electronic medical record at time of first visit and after the bacterial culture result is available 3. Follow-up appointments scheduled, assessed using the patient's electronic medical record at time of first visit and after the bacterial culture result is available | — |
Countries
United States of America
Outcome results
None listed