Acute Otitis Media (AOM) Therapy Trial in Young Children
Summary
The purpose of this study is to learn whether or not all children with ear infections (acute otitis media or AOM) should be treated with antibiotics. The study will compare two treatment strategies, "watchful waiting" or treatment with antibiotics, to determine which is more appropriate for children with AOM. About 268 children in Pittsburgh, between the ages of 6-23 months, with AOM will be enrolled in the study. They will be treated either with Augmentin (an antibiotic) or placebo for 10 days and closely followed for about 1 month. Parents will be asked to write information about their child in a Patient Diary. A general physical exam, including an ear exam, will be performed 4 times during the study. A mucus sample will be collected from the back of each child's nose. Parents will be asked questions during phone calls and at every visit. If a child has not improved or has worsened, the investigators will prescribe a different antibiotic that is known to kill resistant germs.
Timeline
- Start
- 2006-11
- Primary completion
- 2009-04
- Completion
- 2009-04
Outcome
Mixed primary results
registry analysis (superiority or other test); Amoxicillin-Clavulanate vs Placebo; p = .14; Hazard Ratio (HR) 1.22; Regression, Cox NCT00377260 ↗
registry analysis (superiority or other test); Amoxicillin-Clavulanate vs Placebo; p = .04; Hazard Ratio (HR) 1.37; Regression, Cox NCT00377260 ↗
registry analysis (superiority or other test); Amoxicillin-Clavulanate vs Placebo; p = .01; Regression, Linear NCT00377260 ↗
Publications
- Shaikh N, Hoberman A, Paradise JL, Rockette HE, Kurs-Lasky M, Martin JM. Association Between Nasopharyngeal Colonization and Clinical Outcome in Children With Acute Otitis Media. Pediatr Infect Dis J. 2023 Aug 1;42(8):e274-e277. doi: 10.1097/INF.0000000000003956. Epub 2023 Apr 26.
- Hoberman A, Paradise JL, Rockette HE, Shaikh N, Wald ER, Kearney DH, Colborn DK, Kurs-Lasky M, Bhatnagar S, Haralam MA, Zoffel LM, Jenkins C, Pope MA, Balentine TL, Barbadora KA. Treatment of acute otitis media in children under 2 years of age. N Engl J Med. 2011 Jan 13;364(2):105-15. doi: 10.1056/NEJMoa0912254.
- Hoberman A, Paradise JL, Shaikh N, Greenberg DP, Kearney DH, Colborn DK, Rockette HE, Kurs-Lasky M, McEllistrem MC, Zoffel LM, Balentine TL, Barbadora KA, Wald ER. Pneumococcal resistance and serotype 19A in Pittsburgh-area children with acute otitis media before and after introduction of 7-valent pneumococcal polysaccharide vaccine. Clin Pediatr (Phila). 2011 Feb;50(2):114-20. doi: 10.1177/0009922810384259. Epub 2010 Nov 22.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amoxicillin-clavulanate | Other / unclassified | 90 mg/kg | — |