A recent American Academy of Pediatrics (AAP) guideline recommends prompt antimicrobial treatment for children aged 6 months to 2 years with acute otitis media (AOM), with 1 exception: for children in whom the disease is unilateral and also unaccompanied by severe signs or symptoms, the guideline recommends, as an option, observation without initial antimicrobial therapy.1 The recommendation is based on findings from certain clinical trials that suggested little benefit of antimicrobial treatment in such children.2 In those trials, however, criteria used for the diagnosis of AOM were not as stringent as those called for in the recent AAP guideline,1 allowing for the possibility that some of the subjects in those trials did not actually have AOM. Our findings in 2 independent clinical trials,3,4 both of which used stringent diagnostic criteria consistent with those in the recent guideline,1 offer a differing perspective on the relative efficacy of antimicrobial treatment in children younger than 2 years with unilateral, nonsevere AOM.
Our trials were conducted in Pittsburgh, Pennsylvania,3 and Turku, Finland.4 In both trials, stringent criteria were used for diagnosing AOM, children were assigned randomly to receive either amoxicillin–clavulanate potassium or placebo, and parents and research personnel were kept unaware of treatment assignments. In the Pittsburgh trial, treatment failure was defined on day 4 or 5 as lack of substantial improvement in symptoms, worsening of otoscopic signs, or both and on days 10 to 12 as failure to achieve complete or nearly complete resolution of symptoms and otoscopic signs.3 In the Turku trial, treatment failure was defined on day 3 as lack of improvement in the child’s overall condition, on day 8 as lack of improvement in otoscopic signs, and at any time as worsening of the overall condition, the occurrence of tympanic membrane perforation, or inability to continue assigned medication.4 For the present analysis, we combined results from children younger than 2 years in the 2 trials. In keeping with the recent AAP guideline, we defined illness as severe if otalgia was described by parents as moderate or severe or if the child’s temperature had been recorded as, or was estimated to have been, 39°C or more within 24 hours.1 Overall efficacy of amoxicillin-clavulanate was measured by pooling results from the 2 trials in a random-effects model using inverse-variance weighting.5
Results are summarized in the Table. Among children whose infection was unilateral and/or whose illness was nonsevere, those treated with placebo had relatively high rates of treatment failure, whereas those treated with amoxicillin-clavulanate had substantially lower rates. Overall, the effects of antimicrobial treatment were similar across the various laterality and severity subgroups.
These findings make a case for a uniform approach to antimicrobial treatment in children younger than 2 years with stringently diagnosed AOM, irrespective of laterality or apparent severity of their illness, and suggest that the AAP guideline’s recommendation of prompt antimicrobial treatment for children younger than 2 years with AOM that is bilateral and/or apparently severe should be extended to include also those children whose disease is unilateral and apparently nonsevere.
Corresponding Author: Alejandro Hoberman, MD, Division of General Academic Pediatrics, Children’s Hospital of Pittsburgh of UPMC, 4401 Penn Ave, Children’s Hospital Office Bldg, 3rd Floor, Pittsburgh, PA 15201 (firstname.lastname@example.org).
Published Online: September 2, 2013. doi:10.1001/jamapediatrics.2013.3068.
Author Contributions: Study concept and design: All authors.
Acquisition of data: Hoberman, Ruohola, Shaikh, Tähtinen.
Analysis and interpretation of data: Hoberman, Ruohola, Shaikh, Paradise.
Drafting of the manuscript: Hoberman, Ruohola, Shaikh, Paradise.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Hoberman, Ruohola, Shaikh, Paradise.
Obtained funding: Hoberman, Ruohola, Shaikh, Tähtinen.
Administrative, technical, or material support: Hoberman.
Study supervision: Hoberman.
Conflict of Interest Disclosures: None reported.
Hoberman A, Ruohola A, Shaikh N, Tähtinen PA, Paradise JL. Acute Otitis Media in Children Younger Than 2 Years. JAMA Pediatr. 2013;167(12):1171-1172. doi:10.1001/jamapediatrics.2013.3068