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evident
Original paper
2011NEJMPediatrics

Hoberman AOM trial

Treatment of acute otitis media in children under 2 years of age

RCTAcute otitis media

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Overview

In children 6 to 23 months with stringently diagnosed AOM, 10 days of amoxicillin-clavulanate reduced clinical failure; initial symptom resolution did not differ.

Clinical takeaway

Among children 6 to 23 months old with stringently diagnosed acute otitis media, amoxicillin-clavulanate reduced persistent otoscopic signs of infection and overall symptom burden. Initial resolution of symptoms did not differ significantly from placebo.

Key result

Clinical failure was 4% vs 23% at or before day 4 or 5 and 16% vs 51% at or before day 10 to 12 (both P<0.001). Initial symptom resolution did not differ (P=0.14).

Practice impact

Treat stringently diagnosed AOM in children under 2 years with 10 days of amoxicillin-clavulanate; expect fewer persistent exam findings, not a large early symptom difference.

Evidence

Study design

Randomized trial of amoxicillin-clavulanate versus placebo for 10 days.

Enrollment

291

Follow-up

Symptom assessments through day 7 and otoscopic visits through day 10 to 12.

Geography

Not listed

Clinical question

Does immediate amoxicillin-clavulanate improve symptomatic response and reduce clinical failure compared with placebo in children younger than 2 years with acute otitis media?

Population

  • 291 children 6 to 23 months of age with acute otitis media diagnosed with stringent criteria.

Intervention

Amoxicillin-clavulanate for 10 days.

Comparator

Placebo for 10 days.

Primary outcome

Lead reported outcomes were symptomatic response and clinical failure (persistence of signs of acute infection on otoscopic examination); the abstract does not designate a single primary end point.

Initial symptom resolution did not differ significantly (35% vs 28% by day 2, 61% vs 54% by day 4, and 80% vs 74% by day 7; P=0.14 for the overall comparison). Clinical failure was lower with amoxicillin-clavulanate (4% vs 23% at or before day 4 or 5, and 16% vs 51% at or before day 10 to 12; both P<0.001).

Key results

  • Initial resolution of symptoms did not differ significantly: 35% vs 28% by day 2, 61% vs 54% by day 4, and 80% vs 74% by day 7 with amoxicillin-clavulanate vs placebo (P=0.14 for the overall comparison).
  • Sustained resolution of symptoms was 20%, 41%, and 67% with amoxicillin-clavulanate vs 14%, 36%, and 53% with placebo at those same days (P=0.04 for the overall comparison). Mean symptom scores over the first 7 days were lower with amoxicillin-clavulanate (P=0.02).
  • Clinical failure was lower with amoxicillin-clavulanate: 4% vs 23% at or before the visit on day 4 or 5 (P<0.001) and 16% vs 51% at or before the visit on day 10 to 12 (P<0.001).
  • There were no significant changes in either group in nasopharyngeal colonization with nonsusceptible Streptococcus pneumoniae.

Harms

  • Diarrhea and diaper-area dermatitis were more common among children who received amoxicillin-clavulanate.
  • Mastoiditis developed in one child who received placebo.

Clinical Use

Practice impact

  • For children 6 to 23 months with stringently diagnosed AOM, treat with 10 days of amoxicillin-clavulanate to reduce persistent otoscopic infection and symptom burden, and counsel that early symptom resolution may look similar to placebo.

Applicability

  • Most applicable to children 6 to 23 months of age with acute otitis media diagnosed with stringent criteria.

Limitations

  • The abstract does not designate a single numbered primary end point or report confidence intervals.
  • Dose is not stated.
  • Results apply to stringently diagnosed AOM, not to uncertain or loosely diagnosed ear findings.

Common misinterpretations

  • Do not say antibiotics significantly shortened initial symptom resolution; that overall comparison was not significant (P=0.14).
  • This is not a trial of watchful waiting in older children or in AOM diagnosed without stringent criteria.

Citation

Hoberman A, Paradise JL, Rockette HE, et al. Treatment of acute otitis media in children under 2 years of age. N Engl J Med. 2011;364(2):105-115. doi:10.1056/NEJMoa0912254

Among children 6 to 23 months of age with acute otitis media, treatment with amoxicillin-clavulanate for 10 days tended to reduce the time to resolution of symptoms and reduced the overall symptom burden and the rate of persistent signs of acute infection on otoscopic examination.