Amoxicillin for children with CAP: low-dose for 3 days is noninferior to high-dose for 7 days (CAP-IT)

Référence

Bielicki JA, Stohr W, Barratt S, et al, for PERUKI, GAPRUKI, and the CAP-IT Trial Group. Effect of amoxicillin dose and treatment duration on the need for antibiotic re-treatment in children with community-acquired pneumonia. The CAP-IT randomized clinical trial. JAMA 2021;326(17):1713-1724.

Sommaire

Although amoxicillin is widely recommended and used for the treatment of community-acquired pneumonia (CAP) in children, the optimal dose and treatment duration remains uncertain. These investigators identified children, 6 months and older, with clinically diagnosed CAP based on standard international guidelines, who were being discharged from either the emergency department or inpatient ward (within 48 hours of admission). Patients randomly received (concealed allocation assignment) 1 of 4 treatments: (1) amoxicillin (35-50 mg/kg/d) for 3 days; (2) amoxicillin (35-50 mg/kg/d) for 7 days; (3) amoxicillin (70-90 mg/kg/d) for 3 days; or (4) amoxicillin (70-90 mg/kg/d) for 7 days. Masking occurred by using matched active or placebo suspension for days 4 through 7. Individuals masked to treatment group assignment assessed the primary outcome of clinically indicated antibiotic re-treatment for respiratory infection within 28 days of randomization. The noninferiority margin was predetermined to be a conservative 8% difference in outcome rates. Complete follow-up data were available for 97% of participants at 28 days. Using intention-to-treat analysis, the primary outcome occurred in 12.6% of the children in the lower-dose groups versus 12.4% in the higher-dose groups, and in 12.5% in the 3-day treatment groups versus 12.5% in the 7-day treatment groups. Both groups demonstrated noninferiority between dose and duration. Similarly, in the subgroup of children with severe CAP, all groups again demonstrated noninferiority.