Study supports continued use of amoxicillin as first-line therapy for pediatric ear infections

1. In a cohort of more than 1 million children treated for acute otitis media (AOM) in 2018, antibiotic treatment failed in 2.2% and AOM recurred in 3.3%.

2. The rate of treatment failure was significantly lower with amoxicillin therapy than with amoxicillin-clavulanate, cefdinir, or azithromycin, at 1.7% compared to 9.8-11.3%.

Evidence Rating Level: 2 (Good)

Study Rundown: The American Academy of Pediatrics recommends amoxicillin as the first-line antibiotic therapy for children with acute otitis media (AOM). However, since the pneumococcal vaccine became available, H. influenzae and M. catarrhalis, which are often non-susceptible to amoxicillin, have become more common as causes of AOM relative to S. pneumoniae. This large, national retrospective study aimed to characterize current rates of treatment failure and recurrence in AOM and to assess the performance of amoxicillin compared to other antibiotic regimens. More than 1 million children prescribed amoxicillin, amoxicillin-clavulanate, cefdinir, or azithromycin were included. Amoxicillin was prescribed to 56.6%. A large majority, 93%, were prescribed 10 day courses. The rate of treatment failure in all children was low at 2.2% and the rate of recurrence was 3.3%. Treatment failure was significantly more common after prescription of amoxicillin-clavulanate, cefdinir, and azithromycin at 11.3%, 10.0%, and 9.8%, respectively. Given the retrospective study design, it is difficult to determine how much of the difference in rates of failure is due to underlying patient-related differences or differences in infection severity that influenced providers to prescribe broad-spectrum antibiotics rather than amoxicillin. It is also unclear how many infections would have resolved without treatment. Infections caused by pathogens other than S. pneumoniae are more likely to resolve spontaneously, which may in part explain low treatment failure and recurrence rates even in cases where amoxicillin does not theoretically provide good coverage. Despite these limitations in interpretation, this very large national study reflecting real-world antibiotic therapy supports continued use of amoxicillin as a first-line agent in pediatric AOM.

Click to read the study in the Journal of Pediatrics

Relevant Reading: Otitis media: Rapid evidence review

In-Depth [retrospective cohort]: Data on outpatient and emergency AOM visits in 2018 were drawn from the IBM MarketScan Commercial Database, which reflects claims data from a large number of private health insurance plans. Children between 6 months and 12 years old were included. Children requiring hospitalization, with a recent history of tympanostomy tubes, or with multiple comorbidities were excluded. Visits without an associated filling of an antibiotic prescription were also excluded. Cefdinir was prescribed to 20.6%, amoxicillin-clavulanate to 13.5%, and azithromycin to 9.3% of included children. Treatment failure was defined based on filling of the same or another antibiotic 2-14 days after the studied visit. Recurrence was defined as filling the same or another antibiotic 15-30 days after the visit. Prescriptions were filled within 1 day for 98% of visits. Treatment failure and recurrence were more likely in children under 2 years old.

Image: PD

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