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SAFER RCT – 5 or 10 Days for Pediatric CAP?

April 28, 2021

Written by Clay Smith

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In outpatient children with community acquired pneumonia (CAP), 5 days of amoxicillin was non-inferior to 10 days.

Why does this matter?
Using the narrowest spectrum antibiotic for the shortest period of time is key for reducing antibiotic resistance. CAP in children is usually treated with 10 days of amoxicillin as first line therapy. Would a shorter course be just as effective?

Is this SAFER?
This was a two-center RCT with 281 children 6 months to 10 years with CAP comparing outpatient treatment with 5 days of amoxicillin vs 10 days. Pneumonia was diagnosed by presence of recent fever, respiratory symptoms, CXR findings, and “pneumonia” listed as the primary diagnosis. They found no difference in clinical cure rate at 14 to 21 days in the intention to treat (ITT) group, which was the primary outcome. They set the 97.5% lower confidence limit for non-inferiority at -7.5%. In ITT, clinical cure was seen in 85.7% in the 5-day group and 84.1% in the 10-day group (risk difference, 2.3%; 97.5% CL, -6.1%). In the per protocol analysis, clinical cure was 88.6% in the 5-day group and 90.8% in the 10-day group (risk difference, -1.6%; 97.5% CL, -8.7%). A post hoc outcome was created because the authors realized some aspects of “clinical cure,” such as fever spikes after antibiotics with no other findings, no adverse outcomes, and no intervention were not relevant and would not be an indication of clinical failure in practice. This outcome, “clinical cure not requiring additional intervention” occurred in: 93.5% in the 5-day ITT group vs. 90.4% 10-day ITT group; difference 2.8 (97.5%CL −3.8%). I was pretty skeptical as I started reading this. But I think this is probably going to change my practice.

Short-Course Antimicrobial Therapy for Pediatric Community-Acquired Pneumonia: The SAFER Randomized Clinical Trial. JAMA Pediatr. 2021 Mar 8. doi: 10.1001/jamapediatrics.2020.6735. Online ahead of print.

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