Despite the large number of studies conducted, the efficacy of antimicrobial therapy for acute otitis media in children remains a questionable point.

In a randomized, double-blind, placebo-controlled study based on pediatric services at Turku University Hospital (Finland), amoxicillin / clavulanate was compared to placebo in patients with CCA.

The study involved 319 children aged 6 to 35 months with CCA who were randomized to receive amoxicillin / clavulanate (161 children) or placebo (158 children) for 7 days. The main endpoint was the time to treatment failure, which was assessed before the end-of-treatment visit (day 8). The clinical ineffectiveness of the therapy was determined based on an assessment of the child's general condition (including adverse events) and otoscopic signs of ACC.

Treatment failure was observed in 18.6% of children receiving amoxicillin / clavulanate, compared to 44.9% of patients on placebo (p less than 0.001). Differences between the groups were noted from the first scheduled visit (day 3), during which therapeutic failure was observed in 13.7% of children receiving amoxicillin / clavulanate and in 25.3% of children of the placebo group. In general, the use of amoxicillin / clavulanate reduced by 62% the probability of progression of the disease towards clinical ineffectiveness (relative risk 0.38, 95% confidence interval 0.25-0.59, p less than 0.001) and 81% need for prescription “rescue medication” (6.8% vs 33.5%, relative risk 0.19, 95% CI 0.1-0 , 36, p less than 0.001). Pain relievers and antipyretics were prescribed in 84.2% and 85.9% of patients in the amoxicillin / clavulanate and placebo groups, respectively. Adverse events were significantly more frequently recorded in the antibiotic use group compared to placebo. Thus, diarrhea occurred in 47.8% of children receiving amoxicillin / clavulanate and in 26.6% of children in the placebo group (p less than 0.001); in 8.7% and 3.2% of children, respectively, the onset of eczema was noted (p = 0.04).

Thus, the appointment of antibiotics for children with acute otitis media should be considered appropriate, despite the occurrence of adverse events. From the researchers' point of view, to minimize the over-prescribing of antimicrobial treatments and the risk of developing antibiotic resistance, additional studies are needed to identify the category of patients with CAC in whom the appointment of antibiotics is most justified and the most useful.