Treatment failure was significantly more likely in children who received a short course of antibiotics for acute otitis media compared with those who received standard treatment, according to a study in the New England Journal of Medicine.1 Researchers from the University of Pittsburgh compared the effectiveness of a 5-day course of amoxicillin-clavulanate to the standard 10-day regimen in children 6 to 23 months of age. Reducing the duration of antimicrobial treatment has been forwarded as a strategy for curtailing the rise of antibiotic resistance.
For the study, 520 children aged 6 to 23 months with acute otitis media were randomly assigned to receive amoxicillin-clavulanate for either a standard duration of 10 days or for a reduced duration of 5 days followed by placebo similar to the active agent for 5 days. According to the data, 77 of 229 (34%) children who were treated with amoxicillin-clavulanate for 5 days had clinical failure compared with 39 of 238 (16%) children who were treated for 10 days, reflecting a difference of 17 percentage points. In addition, children in the 5-day group were less likely than those in the 10-day group to experience a greater than 50% decline in symptom scores from baseline when assessed at a day-12-to-14 office visit. No significant between-group differences were found for rates of recurrence, adverse events, or nasopharyngeal colonization with penicillin-nonsusceptible pathogens.
The use of short-course antibiotics for acute otitis media has been under exploration for decades, with many previous studies demonstrating absent-to-modest differences in outcomes compared to standard-duration treatment. However, lead investigator Alejandro Hoberman, MD, told Infectious Disease Advisor that there were major methodologic limitations in prior trials, including a focus on the wrong age groups, failure to use stringent definitions of acute otitis media, and insufficient blinding.
When asked about the implications of the study for clinicians who treat patients with acute otitis media, Dr Hoberman stated that he would not consider 5-day over 10-day treatment in children younger than 2 years of age because of the clear differences in efficacy. “On top of that, the short-course treatment did not offer any benefits with regard to adverse events or with regard to the emergence of antibacterial resistance,” he noted. Dr Hoberman said that the opportunity remains for physicians to reduce antimicrobial resistance and the unnecessary use of antibiotics in acute otitis media by adhering to the stringent diagnostic criteria set out in American Academy of Pediatrics clinical practice guidelines, including the diagnostic requirement that there be bulging of the tympanic membrane.2 “Once [otitis media] gets diagnosed properly, a 10-day course of the proper antibiotic is probably the best way to go in young children. However, this has nothing to do with a 5-year-old, a 6-year-old, or a 10-year-old. That’s a totally different story. We cannot generalize our findings to older children.”
- Hoberman A, Paradise JL, Rockette HE, et al. Shortened antimicrobial treatment for acute otitis media in young children. N Engl J Med. 2016;375:2446-2456. doi:10.1056/NEJMoa1606043
- Lieberthal AS, Carroll AE, Chonmaitree T, et al. The diagnosis and management of acute otitis media. Pediatrics. 2013;131:e964-e999. doi:10.1542/peds.2012-3488