Evidence map›Paper›PMID 21226576›Full record

Trial reportThe New England journal of medicine2011

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

Alejandro Hoberman, Jack L Paradise, Howard E Rockette, Nader Shaikh, Ellen R Wald, Diana H Kearney, D Kathleen Colborn, Marcia Kurs-Lasky, Sonika Bhatnagar, Mary Ann Haralam and 5 more

2 registry-linked trialsOpen access · bronzeAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The New England journal of medicine, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 81 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
81citing papers in PubMed, 9 pooled it
36.3field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00377260 phase4completednot on this map

Efficacy of Antimicrobials in Young Children With Acute Otitis Media (AOM)

TypeinterventionalSponsorUniversity of PittsburghRan2006 to 2009Enrolled291ConditionsAcute Otitis MediaArmsamoxicillin-clavulanate, Placebo
NCT07730814 phase4not yet recruitingnot on this mapstarted 2026, after this paper: background citation

Comparative Effectiveness of Available Treatments for Sinus and Ear Infections in Children (Acute Otitis Media)

TypeinterventionalSponsorNader ShaikhRan2026 to 2032Enrolled1,100ConditionsAcute Otitis Media (AOM)ArmsAmoxicillin, Amoxicillin-Clavulanate, Amoxicillin Placebo, Amoxicillin-Clavulanate Placebo
3 · Its place in the literature

Who cites it

81 citing papers in PubMed, 9 syntheses or guidelines pooled it, 299 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Antibiotics for acute otitis media in children.The Cochrane database of systematic reviews · 2023
    Pooled it
  4. Antibiotics for acute otitis media in children.The Cochrane database of systematic reviews · 2015
    Pooled it
  5. Pooled it
  6. Common harms from amoxicillin: a systematic review and meta-analysis of randomized placebo-controlled trials for any indication.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2015
    Pooled it
  7. Pooled it
  8. Impact of pneumococcal conjugate vaccination on otitis media: a systematic review.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2012
    Pooled it
  9. Pooled it
  10. Trial
  11. Trial
  12. Trial
  13. Trial
  14. Trial
  15. Trial
  16. Trial
  17. Article
  18. Article
  19. Use of osteopathic manipulation techniques for management of acute otitis media in pediatric patients: a scoping review.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2025
    Article
  20. Review

21 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 3 institutions in 1 country.

Alejandro HobermanDepartment of Pediatrics, University of Pittsburgh School of Medicine, Children's Hospital of Pittsburgh of the University of Pittsburgh Medical Center, Pittsburgh, PA 15224, USA. hoberman@chp.edu
Jack L Paradise
Howard E Rockette
Nader Shaikh
Ellen R Wald
Diana H Kearney
D Kathleen Colborn
Marcia Kurs-Lasky
Sonika Bhatnagar
Mary Ann Haralam
Lisa M Zoffel
Carly Jenkins
Marcia A Pope
Tracy L Balentine
Karen A Barbadora
Children's Hospital of Pittsburgh · USUniversity of Pittsburgh Medical Center · USUniversity of Pittsburgh · US

Funding

University of Pittsburgh Clinical and Translational Science InstituteUL1TR000005 · NCATS · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI REIS, STEVEN E · 2012 to 2015
$50.8M
Efficacy of Antimicrobials in Young Children with AOMU01AI066007 · NIAID · CHILDREN'S HOSP PITTSBURGH/UPMC HLTH SYS · PI HOBERMAN, ALEJANDRO · 2006 to 2009
$2.0M
NCATS NIH HHS UL1 TR000005NIAID NIH HHS 3U01AI066007-02S1NIAID NIH HHS U01 AI066007
6 · The paper itself

Abstract

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

methodsWe 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.

resultsAmong 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.

conclusionsAmong 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.).

Indexed as

Acute DiseaseAmoxicillin-Potassium Clavulanate CombinationAnti-Bacterial AgentsDiarrheaFemaleHumansInfantMaleNasopharynxOtitis MediaOtoscopyPrognosisRecurrenceRegression AnalysisStreptococcus pneumoniaeTreatment FailureAmoxicillin-Potassium Clavulanate CombinationAnti-Bacterial Agents

Identifiers

PMID21226576
PMCPMC3042231
OpenAlexW2153337742

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.