If You Give Amoxicillin/Clavulanate to Six- to 23-Month-Olds with AOM, 10 Days Is Preferable to Five Days


Am Fam Physician. 2017 Apr 1;95(7):457.

Clinical Question

Is five days of amoxicillin/clavulanate (Augmentin) non-inferior to 10 days of amoxicillin/clavulanate in children with acute otitis media (AOM)?

Bottom Line

These authors begin with the assumption that we should treat children who have AOM with amoxicillin/clavulanate. They demonstrated that outcomes were slightly better with 10 days of treatment compared with five days of treatment in this group of six- to 23-month-olds with rigorously confirmed AOM. The greatest benefit was in children one to two years of age who had more severe pain and fever. In children with less severe symptoms, observation should still be the preferred option, as recommended by the American Academy of Family Physicians guidelines, accompanied by appropriate treatment of pain and fever. (Level of Evidence = 1b)


A previous study by the same lead author (N Engl J Med. 2011;364(2):105–115) found some support for antibiotics in children younger than two years with AOM for the outcome of sustained resolution of symptoms at 14 days (67% vs. 53%; P = .04; number needed to treat [NNT] = 7), but it found no significant difference at two days, four days, or seven days. Children who received amoxicillin/clavulanate had more diarrhea (number needed to treat to harm [NNTH] = 10) and diaper dermatitis (NNTH = 6). Although that seems like a draw, at best, the authors concluded that amoxicillin/clavulanate is appropriate for treatment of AOM.

In this study, the authors identified 520 children, six to 23 months of age, with AOM based on the presence of less than 48 hours of symptoms, a score of 3 or more on a 14-point AOM symptom score, the presence of middle ear effusion, and bulging of the tympanic membrane. A total of 515 were randomly assigned to receive 10 days of amoxicillin/clavulanate or five days of amoxicillin/clavulanate followed by five days of placebo. The dose was 90-mg amoxicillin and 6.4-mg clavulanate per kg. Approximately one-half of the children were six to 11 months of age;

POEMs (patient-oriented evidence that matters) are provided by EssentialEvidence Plus, a point-of-care clinical decision support system published by Wiley-Blackwell. For more information, please see http://www.essentialevidenceplus.com. Copyright Wiley-Blackwell. Used with permission.

For definitions of levels of evidence used in POEMs, see http://www.essentialevidenceplus.com/product/ebm_loe.cfm?show=oxford.

To subscribe to a free podcast of these and other POEMs that appear in AFP, search in iTunes for “POEM of the Week” or go to http://goo.gl/3niWXb.

This series is coordinated by Sumi Sexton, MD, Associate Deputy Editor.

A collection of POEMs published in AFP is available at https://www.aafp.org/afp/poems.



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Mar 15, 2018

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