Eficacia y seguridad de una regla de decisión para orientar el tratamiento en niños con neumonía vacunados contra neumococo: Un ensayo clínico controlado

Introduccion. A pesar de que la mayoria de las neumonias en menores de 5 anos son virales, en la practica diaria, frecuentemente, son tratadas con antibioticos. Una regla clinica de decision (BPS: Bacterial Pneumonia Score) demostro ser eficaz para identificar que ninos con neumonia requerian antibioticos, pero su desempeno no ha sido evaluado en la poblacion vacunada contra neumococo. El objetivo fue evaluar si el empleo del BPS permitia un menor uso de antibioticos comparado con el manejo habitual en ninos con neumonia adquirida en la comunidad, que recibieron vacunacion antineumococcica. Material y metodo. Ensayo clinico controlado, aleatorizado, de grupos paralelos, con enmascaramiento parcial, que compara dos metodos de manejo de ninos de 3-60 meses de edad asistidos ambulatoriamente por neumonia, que hubieran recibido vacuna antineumococcica conjugada. El Grupo BPS recibio antibioticos con BPS > 4 puntos; el grupo control recibio antibioticos segun criterio del medico tratante. El tamano muestral calculado contemplo, al menos, 30 pacientes por grupo. Se comparo la proporcion de uso de antibioticos y la evolucion clinica en ambos grupos. Resultados. Se incluyeron 65 pacientes (33 en el grupo BPS y 32 en el grupo control), con edad promedio de 17,5 meses. El empleo de antibioticos fue significativamente mayor en el grupo control que en el grupo BPS (21/32 vs. 9/33; OR 5,09; IC 95%: 1,57-16,85; p = 0,001). Se observo una mala evolucion en 7 pacientes (3 del grupo BPS y 4 del grupo control). Conclusion. El empleo de BPS permitio un menor uso de antibioticos para el manejo inicial de pacientes con neumonia vacunados contra neumococo, sin aumentar el riesgo de mala evolucion.(AU) Introduction. Although most cases of pneumonia in children younger than 5 years old have a viral nature, in everyday practice, they are frequently treated with antibiotics. A clinical decision rule (BPS:Bacterial Pneumonia Score) proved to be effective for identifying which children with pneumonia required antibiotics, but its performance has not been assessed in the population vaccinated against pneumococcal disease. Our objective was to assess whether using the BPS would allow to reduce antibiotic use compared to routine management of children with community acquired pneumonia vaccinated against pneumococcal disease. Material and Methods. Randomized, controlled, partially-blinded clinical trial with parallel groups comparing two approaches in the management of children aged 3-60 months old in an outpatient setting because of pneumonia, who had been vaccinated with the pneumococcal conjugate vaccine.The BPS group received antibiotics with a BPS >4 points; while the control group was administered antibiotics at the discretion of the treating physician. The estimated sample size was calculated as, at least, 30 patients per group. The rate of antibiotic use and the clinical course were compared in both groups. Results. Sixty-five patients (33 in the BPS group and 32 in the control group) were included; their average age was 17.5 months old. Antibiotic use was significantly higher in the control group than in the BPS group (21/32 versus 9/33; OR: 5.09; 95% CI: 1.57-16.85; p= 0.001). Seven patients had an unfavorable course (three in the BPS group, and four in the control group). Conclusion. The use of the BPS allowed to reduce antibiotic use in the initial management of patients with pneumonia vaccinated against pneumococcal disease, without increasing the probability of an unfavorable course of the disease.(AU)