Berlin Group A streptococci study - BASE study Multi-centre investigation on the influence of molecular group A streptococci diagnostics on the management of tonsillopharyngitis (pharynx/tonsillitis) in pediatric practices in Berlin.
- Conditions
- J03.0Streptococcal tonsillitis
- Registration Number
- DRKS00034362
- Lead Sponsor
- Sana Klinikum Lichtenberg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 1241
•Volunteers of both sexes between the ages of 3 and <18 years old.
•Managed in primary care by a general practitioner or primary care paediatrician.
•With a clinical diagnosis of acute pharyngitis, defined as an inflammation of the pharynx and/or tonsils (i.e., erythema with or without exudate) or acute sore throat (even if without local signs of pharyngeal inflammation.
•Fever >38°C (at presentation or also reported by parents)
•Non-opposition of the accompanying parent(s).
•Willingness to participate in the study as evidenced by the signing of the Informed Consent Form (ICF) by the parent/guardian.
•Children who received antibiotics within 7 days before potential inclusion.
•Children already enrolled in the study for the same episode of pharyngitis.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint is measured as a binary event at the patient level and is the decision by the physician to prescribe antibiotics (yes/no) during the initial visit.
- Secondary Outcome Measures
Name Time Method 1)Number of reported sick days by the parents in the molecular POC cohort and the routine cohort within 7 days after the initial visit. <br>2)Number of children requiring re-assessment (for upper respiratory infection) by a physician within 7 days in the molecular POC cohort and the routine cohort.<br>3)Number of children that required hospitalization (all causes) within 7 days in the molecular POC cohort and the routine cohort.<br>