Terapia per la polmonite acquisita in comunità non complicata in bambini in età prescolare dimessi a domicilio: confronto tra Amoxicillina a basso o alto dosaggio per 3 o 7 giorni. I risultati del RCT inglese CAP-IT

Abstract

Therapy for uncomplicated community-acquired pneumonia in preschool children discharged from ED: comparison of low-dose or high-dose Amoxicillin for 3 or 7 days. Results of the English RCT CAP-IT This study is the first one performed in Western countries that used a 3-day therapy for uncomplicated community-acquired pneumonia (CAP), already tested several times in low- and medium-income countries. This study, carried out in UK, is a double-blind RCT of good methodological quality. The study compared the efficacy of 4 different therapeutic regimens by dose (high or low) and by duration (3 or 7 days) versus placebo, in the treatment of 824 children older than 6 months and weighing between 6 and 24kg with CAP, discharged from emergency room or hospital. Approximately 12% of cases across all regimens require further antibiotic therapy for a new respiratory infection within 28 days from randomization; 5% of children enrolled experienced a severe adverse event requiring hospitalization. Both groups demonstrated noninferiority with no significant interaction between doses and duration. In the subgroup with more severe symptoms at enrolment (i.e., those with at least two altered thoracic physiologic parameters) 17.3% of recipients of a lower dose versus 13.5% of those treated with the higher dose require additional antibiotic therapy by 28th day, but the difference is not statistically significant. The limitations related to the non-inferiority design and the composition of the studied population, which limit the transferability of the results, are discussed.