Abstract
The development of new diagnostic techniques to support the initial clinical evaluation is one of the key strategies to mitigate the inappropriate antibiotic prescription in Pediatrics. We conducted a prospective observational study to test a novel chemiluminescence assay that helps differentiating bacterial and viral infections by combining three host-response proteins (C-reactive protein, TRAIL and IP-10). We enrolled 255 children (age 1-243 months) presenting to a Pediatric Infectious Diseases Unit with fever (60%), cough (22.4%), gastrointestinal symptoms (22%), proven infection (38%). The 22.7% of patients carried at least one comorbidity. The baseline test demonstrated 51% sensitivity and 91% specificity. The diagnostic accuracy was better than traditional biomarkers (C-reactive protein, white blood cell count). Stratifying the analysis by pre-admission antibiotic treatment, naïve patients showed higher sensitivity for bacterial infection (0.70 vs. 0.15), better negative predictive value (0.60 vs. 0.45) and lower error rate (0.24 vs. 0.51). A significant score reduction was observed shortly after starting antibiotic therapy in a subgroup with microbiologically confirmed bacterial diagnosis (mean - 45.12, mean interval = 4 days). We concluded the test could improve infection management in pediatric settings, support initial therapy decision and potentially reduce unnecessary antibiotics. However, its optimal implementation requires a precise definition of the target population.