In another secondary analysis of cohorts from a single RCT (315 patients), children with high temperature or vomiting who were treated immediately with antibiotics were less likely to be in distress by day 3 of illness (32% immediate vs 53% delayed; P=.045; NNT=5) or have night disturbance (26% immediate vs 59% delayed; P=.002; NNT=3). The greatest benefit occurred among children younger than 2 years and children with bilateral infection (NNT=4). The outcomes were reported by parents, who were not blinded.7
One regimen is as effective as another
In meta-analyses of subsets of a systematic review that included 74 RCTs and 6 cohort studies, the 1- to 7-day clinical failure rate among children not given antibiotics for AOM was 19% (95% CI, 0.10-0.28). Patients treated with ampicillin or amoxicillin had a 2- to 7-dayclinical failure rate of 7% (NNT=8; 95% CI, 0.04-0.20). Pooled analyses did not show any difference in efficacy between comparisons of penicillin, ampicillin, amoxicillin (2 or 3 times daily; standard or high dose), amoxicillin-clavulanate, cefaclor, cefixime, ceftriaxone, azithromycin, and trimethoprim-sulfamethoxazole.
An 8% higher incidence of diarrhea was noted for cefixime compared with amoxicillin (number needed to harm=12; 95% CI, 0.04-0.13). Azithromycin had a 19% lower adverse event rate than amoxicillin-clavulanate (NNT=5; 95% CI, 0.09-0.29).8
Five days of treatment are as good as 10
A 2000 Cochrane review found that 5 days of antibiotic therapy was as effective as a 10-day course of treatment in otherwise healthy children with uncomplicated AOM. A slight increase in signs, symptoms, relapse, or reinfection among children receiving 5 days of antibiotics was noted at 8 to 18 days after treatment (OR=1.52; 95% CI, 1.17-1.98), but the finding was no longer statistically significant at 30 days (OR=1.22; 95% CI, 0.98-1.54).9
Recommendations
The American Academy of Pediatrics recommends amoxicillin 80 to 90 mg/kg per day in 2 divided doses for:
- all children younger than 6 months with AOM
- children 6 to 24 months old with a certain diagnosis of AOM (rapid onset, signs of middle-ear effusion, and signs and symptoms of middle-ear inflammation) or severe illness (moderate to severe otalgia or fever ≥102.2°F [39°C])
- children older than 24 months with severe illness.
All other children may be observed if the caregiver consents and is able to monitor the child and if systems are in place for follow-up communication, reevaluation, or access to medication.
Children with a non-type-I penicillin allergy can be given a second- or third-generation cephalosporin, such as cefdinir (14 mg/kg per day in 1 or 2 doses), cefpodoxime (10 mg/kg per day in 1 dose), or cefuroxime (30 mg/kg per day in 2 divided doses). If the child is at high risk of anaphylaxis, 2 acceptable options are azithromycin (10 mg/kg on day 1 followed by 5 mg/kg per day for 4 days as a single daily dose) or clarithromycin (15 mg/kg per day in 2 divided doses).
Amoxicillin should not be given to children at risk for highly amoxicillin-resistant organisms (eg, children who have had antibiotics in the previous 30 days, concomitant purulent conjunctivitis, chronic prophylactic amoxicillin). The recommended alternative is high-dose amoxicillin-clavulanate (90 mg/kg per day of amoxicillin and 6.4 mg/kg per day of clavulanate in 2 divided doses).4