Clinical Question

Is five days of amoxicillin/clavulanate (Augmentin) non-inferior to 10 days of amoxicillin/clavulanate in children with acute otitis media (AOM)?

Bottom Line

These authors begin with the assumption that we should treat children who have AOM with amoxicillin/clavulanate. They demonstrated that outcomes were slightly better with 10 days of treatment compared with five days of treatment in this group of six- to 23-month-olds with rigorously confirmed AOM. The greatest benefit was in children one to two years of age who had more severe pain and fever. In children with less severe symptoms, observation should still be the preferred option, as recommended by the American Academy of Family Physicians guidelines, accompanied by appropriate treatment of pain and fever. (Level of Evidence = 1b)

Synopsis

A previous study by the same lead author (N Engl J Med. 2011;364(2):105–115) found some support for antibiotics in children younger than two years with AOM for the outcome of sustained resolution of symptoms at 14 days (67% vs. 53%; P = .04; number needed to treat [NNT] = 7), but it found no significant difference at two days, four days, or seven days. Children who received amoxicillin/clavulanate had more diarrhea (number needed to treat to harm [NNTH] = 10) and diaper dermatitis (NNTH = 6). Although that seems like a draw, at best, the authors concluded that amoxicillin/clavulanate is appropriate for treatment of AOM.

In this study, the authors identified 520 children, six to 23 months of age, with AOM based on the presence of less than 48 hours of symptoms, a score of 3 or more on a 14-point AOM symptom score, the presence of middle ear effusion, and bulging of the tympanic membrane. A total of 515 were randomly assigned to receive 10 days of amoxicillin/clavulanate or five days of amoxicillin/clavulanate followed by five days of placebo. The dose was 90-mg amoxicillin and 6.4-mg clavulanate per kg. Approximately one-half of the children were six to 11 months of age; the remainder were 12 to 23 months of age; 54% were male; and one-half had bilateral AOM. Groups were balanced at the beginning of the study, and analysis was by intention to treat. Children were evaluated at four to six days and again at 12 to 14 days. A treatment failure was defined as worsening symptoms, worsening tympanic membrane bulging, or lack of complete or nearly complete symptom resolution. Children who experienced a clinical failure received rescue therapy with additional broad-spectrum antibiotics.

At the end of treatment, the likelihood of clinical failure was greater in the five-day group than in the 10-day group (34% vs. 16%; 95% confidence interval for difference, 9% to 25%; NNT = 6). The magnitude of this difference between groups was greater for children 12 to 23 months of age than for younger children (24% vs. 11%) and for children with more severe pain and fever on presentation (27% vs. 6%). The likelihood of a greater than 50% reduction in the symptom score from baseline was higher in the 10-day group, although not by much (91% vs. 80%; P = .003; NNT = 9). There was no difference in the likelihood of diarrhea or diaper dermatitis between groups: five days were as bad as 10 days, with approximately one-third of the children experiencing each of these adverse effects.

Study design: Randomized controlled trial (double-blinded)

Funding source: Government

Allocation: Concealed

Setting: Outpatient (primary care)

Reference:Hoberman A, Paradise JL, Rockette HE, et al. Shortened antimicrobial treatment for acute otitis media in young children. N Engl J Med. 2016;375(25):2446–2456.