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

Hoberman, A and Paradise, JL and Rockette, HE and Shaikh, N and Wald, ER and Kearney, DH and Colborn, DK and Kurs-Lasky, M and Bhatnagar, S and Haralam, MA and Zoffel, LM and Jenkins, C and Pope, MA and Balentine, TL and Barbadora, KA (2011) Treatment of acute otitis media in children under 2 years of age. New England Journal of Medicine, 364 (2). 105 - 115. ISSN 0028-4793

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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; number, NCT00377260.) Copyright © 2011 Massachusetts Medical Society.


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Item Type: Article
Status: Published
CreatorsEmailPitt UsernameORCID
Hoberman, Aalejo@pitt.eduALEJO
Paradise, JL
Rockette, HE
Shaikh, Nnas67@pitt.eduNAS67
Wald, ER
Kearney, DH
Colborn, DK
Kurs-Lasky, M
Bhatnagar, S
Haralam, MA
Zoffel, LM
Jenkins, C
Pope, MA
Balentine, TL
Barbadora, KA
Date: 13 January 2011
Date Type: Publication
Journal or Publication Title: New England Journal of Medicine
Volume: 364
Number: 2
Page Range: 105 - 115
DOI or Unique Handle: 10.1056/nejmoa0912254
Schools and Programs: Graduate School of Public Health > Biostatistics
School of Medicine > Pediatrics
Refereed: Yes
ISSN: 0028-4793
MeSH Headings: Acute Disease; Amoxicillin-Potassium Clavulanate Combination--adverse effects; Amoxicillin-Potassium Clavulanate Combination--therapeutic use; Anti-Bacterial Agents--adverse effects; Anti-Bacterial Agents--therapeutic use; Diarrhea--chemically induced; Female; Humans; Infant; Male; Nasopharynx--microbiology; Otitis Media--diagnosis; Otitis Media--drug therapy; Otoscopy; Prognosis; Recurrence; Regression Analysis; Streptococcus pneumoniae--isolation & purification; Treatment Failure
Other ID: NLM NIHMS264759, NLM PMC3042231
PubMed Central ID: PMC3042231
PubMed ID: 21226576
Date Deposited: 10 Sep 2012 14:44
Last Modified: 02 Feb 2019 16:56


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