Trial reportEuropean journal of pediatrics2026
Multi-center investigation on the influence of clinical characteristics and molecular group A streptococci diagnostics on the management of tonsillopharyngitis in pediatric practices in Berlin-BASE study.
Trial report in European journal of pediatrics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
A clear distinction between viral, bacterial, or non-infectious tonsillopharyngitis is not always possible due to overlapping clinical symptoms. Patient near point-of-care diagnostics may contribute to supporting clinical assessment and, in turn, guide antibiotic treatment. We performed a prospective cluster-randomized multi-center study with cross-over design in 25 pediatric offices located in and around the city of Berlin, Germany, from December 2023 to May 2024. The primary objective was to determine whether using a rapid molecular point of care test (mPOC) reduces antibiotic prescription rates in children 3 to <18 years of age with febrile tonsillopharyngitis. As a secondary objective, sick days, re-assessments, and hospitalizations were evaluated. A total of 1111 patients were included in the final analysis. A positive test result in the mPOC group was observed in 67.1% (n = 471/702) and 65.8% (n = 194/295) in the standard care (SC) control group (which had optional rapid antigen testing). Interestingly, only 27.9% (n = 114/409) of children in the SC group were managed exclusively on a clinical diagnosis. Overall, two-thirds of all patients received a prescription for antibiotics (67.2%; n = 747/1111), with no significant difference between the study groups. In 95.5% (n = 635/665) of children with a positive test, an antibiotic was prescribed, as well as in 10.8% (n = 36/332) of test-negative cases. The probability of prescribing antibiotics was significantly higher when the McIsaac score was ≥3 (OR =4.67 (CI 95% 3.22-6.79, p < 0.0001)). In patients <5 years, the number of sick leave days was 37% higher than in older ones (IRR = 1.37 (95% CI 1.18-1.59, p<0.0001)).
conclusionA McIsaac score ≥ 3 and a positive streptococcal test result were strong drivers for antibiotic prescription. No difference in antibiotic prescription rates between study groups was observed. Antibiotic usage was high in our patient cohort and requires further efforts regarding diagnostic and antibiotic stewardship. Tonsillopharyngitis also utilized substantial resources during follow-up. WHAT IS KNOWN: • A clear distinction between viral, bacterial, or non-infectious pharyngitis is not always possible due to the overlapping clinical symptoms. • Rapid antigen tests (RADT) or molecular diagnostic tests (mPOC) as part of point-of-care testing may contribute to antibiotic treatment guidance. WHAT IS NEW: • In children with febrile tonsillopharyngitis, we could not observe a reduction in antibiotic prescription rates using mPOC compared to routine care, including RADT. • Further efforts regarding diagnostic and antibiotic stewardship are warranted. Trial registration number (DRKS-ID): DRKS00034362.
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