Pediatric Pearls: A Short Course of Antibiotics for Pneumonia
A 6-year-old girl presents with fever and respiratory symptoms. Imaging results are consistent with pneumonia. The child's parents were both recently diagnosed with pneumonia and were given a 5-day course of antibiotics. They ask if the same treatment is appropriate for their child.
(Answer and discussion on next page)
Jessica L Tomaszewski, MD, is a pediatrician in the Division of General Pediatrics/Primary Care in the Department of Pediatrics at Nemours duPont Pediatrics, Jessup Street, in Wilmington, DE.
It has been established that a 5-day course of antibiotics is as effective as longer courses for the treatment of community-acquired pneumonia in adults. There is less existing research regarding effective duration of therapy in children, particularly randomized controlled trials.
To better understand the effects in children, researchers conducted the SAFER (Short-Course Antimicrobial Therapy for Pediatric Respiratory Infections) study. This randomized clinical trial was conducted as a single-center pilot study and then a follow-up main study. Participants included individuals aged 6 months to 10 years who had had a fever within 48 hours of presentation, respiratory symptoms and imaging results consistent with pneumonia, and a primary diagnosis of pneumonia. Participants were excluded from the study if they were admitted to the hospital, had underlying conditions that would predispose them to severe disease, or had recently taken antibiotic therapy. Participants were given either 5 days of high-dose amoxicillin followed by 5 days of placebo or 5 days of amoxicillin followed by a different formulation of 5 days of high-dose amoxicillin.
Outcome measures of the study were identified by clinical cure at 14 to 21 days and were obtained via caregiver diaries, calls to check in, and an assessment in the 14- to 21-day period. Clinical cure was defined by several factors: initial improvement of fever and/or respiratory symptoms during enrollment and at follow-up assessment, no more than 1 fever spike from day 4 until the reassessment at 14 to 21 days later, and no need for further antimicrobials or admission because of progression of illness.
There were 281 participants in this study blindly and randomly assigned 1:1 to the intervention group or the control group. In an intention-to-treat analysis, clinical cure at 14 to 21 days after enrollment was similar between the 2 groups, with cure reported in 108 of 126 participants (85.7%) in the intervention group and 106 of 126 (84.1%) in the control group.
The most interesting part of this study was the analysis of the results. It was determined that the definition of a clinical failure in the context of a randomized clinical trial was perhaps more stringent than a true clinical failure. In a post-hoc analysis, a secondary cure outcome was created: clinical cure not requiring additional intervention (no additional antibiotics, no deterioration). With this in mind, clinical cure not requiring intervention was documented in 116 of 124 patients (93.5%) in the intervention group and 113 of 125 (90.4%) in the control group of the intention-to-treat analysis.
When the participants who did experience clinical failure were examined, many (82.4%) had either Mycoplasma pneumoniae or a previously undetected respiratory virus. Further studies may be needed to determine how many of these initial illnesses were viral in nature and whether viral testing should be consistently included.
Bottom Line—This study suggests that, much like in adults, 5 days of therapy may be sufficient for treating uncomplicated outpatient pneumonia in children. While it may still take time to shift traditional dosing duration, continued re-evaluation of appropriate antibiotic use remains an essential part of current practice.
Pernica JM, Harman S, Kam AJ, et al. Short-course antimicrobial therapy for pediatric community-acquired pneumonia: the SAFER randomized clinical trial. Published online March 8, 2021. JAMA Pediatr. https://doi.org/10.1001/jamapediatrics.2020.6735