An article in JAMA Pediatrics reports results of a two-center, blinded, randomized, clinical trial of children treated with short-course antibiotic therapy. It notes that those patients had comparable rates of clinical cure at 14 to 21 days after enrollment compared with standard care (85.7% vs. 84.1%).
In fact, Canadian researchers from McMaster University point out that because short-course therapy for pediatric community-acquired pneumonia (CAP) not requiring hospitalization appears to offer more benefit than harm, it should be considered for inclusion in treatment guidelines.
“Several studies have proven that adults with pneumonia do fine with short courses of antibiotics, and now we have proved a short course of antibiotics also works for children,” said lead author s Jeffrey Pernica, MD, associate professor of pediatrics of McMaster’s Michael G. DeGroote School of Medicine and an infectious-disease pediatrician for Hamilton Health Sciences.
The study notes that evidence-based recommendations are necessary for pediatric CAP because it is such a common occurrence. Researchers sought to determine whether 5 days of high-dose amoxicillin for CAP was associated with noninferior rates of clinical cure compared with 10 days of high-dose amoxicillin.
Their effort, the SAFER (Short-Course Antimicrobial Therapy for Pediatric Respiratory Infections) study, was a two-center, parallel-group, noninferiority randomized clinical trial consisting of a single-center pilot study from December 1, 2012, to March 31, 2014, with follow-up from August 1, 2016, to December 31, 2019, and analysis in 2020.
Investigation was conducted at the emergency departments of McMaster Children’s Hospital and the Children’s Hospital of Eastern Ontario.
The 281 participants were aged 6 months to 10 years—median age of 2.6 years and 575.7% boys—had fever within 48 hours, respiratory symptoms, chest radiography findings consistent with pneumonia as per the emergency department physician, and a primary diagnosis of pneumonia. Interventions included 5 days of high-dose amoxicillin therapy followed by 5 days of placebo (intervention group) versus 5 days of high-dose amoxicillin followed by a different formulation of 5 days of high-dose amoxicillin (control group).
The study team was focused on clinical cure at 14 to 21 days and observed it in 101 of 114 children (88.6%) in the intervention group and in 99 of 109 (90.8%) in the control group in per-protocol analysis (risk difference, −0.016; 97.5% confidence limit, −0.087). Clinical cure at 14 to 21 days was observed in 108 of 126 (85.7%) in the intervention group and in 106 of 126 (84.1%) in the control group in the intention-to-treat analysis (risk difference, 0.023; 97.5% confidence limit, −0.061).
“Short-course antibiotic therapy appeared to be comparable to standard care for the treatment of previously healthy children with CAP not requiring hospitalization,” the researchers write. “Clinical practice guidelines should consider recommending 5 days of amoxicillin for pediatric pneumonia management in accordance with antimicrobial stewardship principles.”
“The dramatic increase in antimicrobial resistance in the world today is driven by overuse of antibiotics—which has only worsened during the COVID-19 pandemic,” Dr. Pernica added. “This is why we need these clinical studies—to figure out how short we can make antibiotic treatment courses for common infections.”
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