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Randomized Controlled Trial
, 364 (2), 105-15

Treatment of Acute Otitis Media in Children Under 2 Years of Age

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Randomized Controlled Trial

Treatment of Acute Otitis Media in Children Under 2 Years of Age

Alejandro Hoberman et al. N Engl J Med.

Abstract

Background: Recommendations vary regarding immediate antimicrobial treatment versus watchful waiting for children younger than 2 years of age with acute otitis media.

Methods: We randomly assigned 291 children 6 to 23 months of age, with acute otitis media diagnosed with the use of stringent criteria, to receive amoxicillin-clavulanate or placebo for 10 days. We measured symptomatic response and rates of clinical failure.

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=0.14 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=0.04 for the overall comparison). Mean symptom scores over the first 7 days were lower for the children treated with amoxicillin-clavulanate than for those who received placebo (P=0.02). The rate of clinical failure--defined as the persistence of signs of acute infection on otoscopic examination--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<0.001) and 16% versus 51% at or before the visit on day 10 to 12 (P<0.001). 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.

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. (Funded by the National Institute of Allergy and Infectious Diseases; ClinicalTrials.gov number, NCT00377260.).

Conflict of interest statement

No other potential conflict of interest relevant to this article was reported.

Figures

Figure 1
Figure 1. Enrollment, Randomization, and Follow-up of Children in the Study
Mean scores on the Acute Otitis Media Severity of Symptoms (AOM-SOS) scale range from 0 to 14, with higher scores indicating greater severity of symptoms.
Figure 2
Figure 2. Resolution of Children's Symptoms during the First 7 Days of Follow-up
During the first 3 days, the Acute Otitis Media Severity of Symptoms (AOM-SOS) scale, was administered twice daily; thereafter, it was administered once daily. Panels A and B show the proportion of children in whom symptoms had not resolved. Resolution of symptoms is defined in Panel A as the first recording of an AOM-SOS score of 0 or 1 and in Panel B as the second of two successive recordings of a score of 0 or 1. Panel C shows the mean scores on the AOM-SOS scale over the course of the first 7 days of the study treatment. Since multiple assessments were made on the first 3 study days, numbers on the x axis in all three panels indicate the end of a study day.

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