Clinical Outcomes Associated with Amoxicillin Treatment for Acute Otitis Media in Children.

BACKGROUND: Acute otitis media (AOM) is the most common reason children are prescribed antibiotics. Bacteria that produce beta-lactamase are an increasingly frequent cause of AOM and may be resistant to amoxicillin, the currently recommended treatment for AOM. We aimed to evaluate clinical outcomes of children treated with amoxicillin for AOM and assessed whether outcomes vary by infecting pathogen or beta-lactamase production.

METHODS: 205 children 6-35 months old diagnosed with AOM and prescribed amoxicillin were included. Bacterial culture and RT-PCR were performed on nasopharyngeal swabs collected at enrollment. Parents completed surveys assessing symptoms, antibiotic adherence, and potential adverse events. The primary outcome was treatment failure with amoxicillin. Secondary outcomes included recurrence, symptom improvement, resolution, and adverse drug events.

RESULTS: 8 children (5.4%) experienced treatment failure and 14 (6.8%) had recurrence. By Day 5, 152 (74.1%) children had symptom improvement and 97 (47.3%) had resolution. Parents reported adverse drug events for 56 (27.3%) children. Among 149 children who did not take any amoxicillin before enrollment, 98 (65.8%) had one or more beta-lactamase-producing bacteria. Common bacterial otopathogens were M. catarrhalis (79, 53.0%), S. pneumoniae (51, 34.2%), H. influenzae (30, 20.1%), and S. aureus (21, 14.1%). Treatment failure did not differ between children that did (5, 5.1%) and did not (3, 5.9%) have beta-lactamase-producing otopathogens (p=0.05).

CONCLUSIONS: Among children diagnosed with AOM treated with amoxicillin, treatment failure was uncommon and did not differ by pathogen or beta-lactamase production. These data support guidance recommending amoxicillin despite an increasing prevalence of beta-lactamase-producing bacteria.