Children under 2 years of age with acute otitis media benefit from antibiotic treatment

Article Outline

• Question
• Design
• Setting
• Participants
• Intervention
• Outcomes
• Main Results
• Conclusions
• Commentary
• Reference
• Copyright

Hoberman A, Paradise JL, Rockette HE, Shaikh N, Wald ER, Kearney DH, et al. Treatment of acute otitis media in children under 2 years of age. N Engl J Med 2011;364:105-15.

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Question 

For young children (<2 years) with acute otitis media (AOM), do antibiotics result in more rapid resolution of symptoms compared with watchful waiting?

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Design 

Randomized, controlled trial.

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Setting 

Children's Hospital of Pittsburgh and an affiliated private practice in Kittanning, Pennsylvania.

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Participants 

291 children 6 to 23 months of age, with acute otitis media. Children were stratified based on history of recurrent AOM and exposure to multiple other children.

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Intervention 

Amoxicillin-clavulanate (90 mg/kg of amoxicillin) or placebo for 10 days.

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Outcomes 

The primary outcome measures were the time to resolution of symptoms and the symptom burden over time. Rates of clinical failure (the persistence of signs of acute infection on otoscopic examination) were also assessed.

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Main Results 

Among the children who received amoxicillin-clavulanate, 35% had initial resolution of symptoms by day 2, 61% by day 4, and 80% by day 7; among children who received placebo, 28% had initial resolution of symptoms by day 2, 54% by day 4, and 74% by day 7 (P = .14 for the overall comparison). For sustained resolution of symptoms, the corresponding values were 20%, 41%, and 67% with amoxicillin-clavulanate, as compared with 14%, 36%, and 53% with placebo (P = .04 for the overall comparison, range for number needed to treat [NNT] = 8-20). Mean symptom scores over the first 7 days were lower for the children treated with amoxicillin-clavulanate than for those who received placebo (P = .02). The rate of clinical failure was also lower among the children treated with amoxicillin-clavulanate than among those who received placebo: 4% versus 23% at or before the visit on day 4 or 5 (P < .001, NNT = 6) and 16% versus 51% at or before the visit on day 10 to 12 (P < .001, NNT = 3). Mastoiditis developed in one child who received placebo. Diarrhea and diaper-area dermatitis were more common among children who received amoxicillin-clavulanate. There were no significant changes in either group in the rates of nasopharyngeal colonization with nonsusceptible Streptococcus pneumoniae.

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Conclusions 

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.

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Commentary 

In recent years, there have been a plethora of studies about withholding initial antibiotic therapy for treatment of AOM and observing the progress of the disease. We know that many infants do not benefit from antibiotics because many of the episodes are due to viral infections; however, even bacterial infections may resolve without antibiotics. The “observation” option was sufficiently persuasive that the American Academy of Pediatrics included observation rather than treatment if the diagnosis was uncertain and the disease was non-severe. The key was “uncertain diagnosis” and “non-severe.” “Observation” did not mean “no treatment”; it meant that the child would not be treated at the first visit. Hoberman et al and an accompanying study by Tahtinen et al from Turku, Finland, designed placebo controlled double blinded studies to respond to the issue.¹ The results of both studies support the use of antibiotics for initial management of infants. The discussion about initial treat or observe is not over, but we are closer to a consensus that the infants who may be observed are those whose diagnosis is uncertain and whose signs are not severe. AOM is a treatable disease for all infants with a definite diagnosis of AOM.

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Reference 

1. Tahtinen PA, Laine MK, Huovinen P, Jalava J, Ruuskanen O, Ruohola A. A placebo-controlled trial of antimicrobial treatment for acute otitis media. N Engl J Med. 2011;364:116–126
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