1. Between a 7-day course of amoxicillin or placebo, there was no significant different in symptom duration and no clinically significant difference in symptom severity.
2. There was no significant difference in adverse events (rash, diarrhea, nausea) between the two groups.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Antibiotic misuse has been seen across all healthcare fields, but it may be especially present in pediatrics. Lower respiratory tract infections (LRTI) are typically viral and are unlikely to benefit from antibiotics. This randomized-control trial assigned children with uncomplicated LRTI (non-pneumonic) symptoms presenting to primary care to receive either a course of amoxicillin or placebo for 7 days. Symptoms were monitored by parents at home who recorded severity on a scale of 0-6 in a diary for 1-4 weeks. According to the findings, there was no significant difference in length of symptoms between the two groups. There was a slight improvement in symptom severity in the amoxicillin group in the first 2-4 days; however, this was not clinically significant. No differences in adverse events or medication side effects were seen. Limitations of this study include the symptom diary which was only fully completed for 73% of patients, the remaining which had to be imputed. Nevertheless, this study indicates that amoxicillin likely has little to no clinical benefit in children presenting with uncomplicated LRTI in the primary care setting. This data will support primary care physicians in their clinical decision making.
In-Depth [randomized controlled trial]: This multicentre study collected data from 56 primary care settings in England. Children with LRTIs aged 6 months to 12 years were included in the study. Duration of presenting illness must have been less than 21 days. LRTIs were clinically diagnosed by primary care providers by symptoms of shortness of breath, sputum, pain and the criteria used to diagnose acute bronchitis. Children were excluded if the cause was non-infectious (eg. Asthma) or they had received antibiotics in the previous 30 days. Patients were randomized 1:1 into either placebo (n=211) or amoxicillin (n=221) 50 mg/kg orally for 7 days. 54% of the participants were male and the median age was 3.2 years. Baseline characteristics were similar between the two groups after randomization (ex. clinical symptoms upon presentation, comorbidities).
Parents kept a symptom diary for at least 1 week, to a maximum of 4 weeks. Symptoms were ranked on a scale of 0-6 for severity and included cough, phlegm, shortness of breath, wheezing, blocked or runny nose, disturbed sleep, feeling unwell, fever, and interference with normal activities. Follow-up was done at the primary care practice after 1 month. Secondary outcomes included the severity of specific symptoms and complications of the medication (diarrhea, rash, or nausea).
73% of patients had complete data on symptom duration. There was no significant difference in symptom duration between the two groups: 5 days [IQR 4-11] in amoxicillin versus 6 days [4-15] in placebo (HR 1.13 [95% CI 0.90-1.42]). There were significantly less severe symptoms on days 2-4 after receiving the medication (1.8 in antibiotic vs. 2.1 in placebo); however, this is arguably not clinically significant. There were no differences in adverse events between the two groups.
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