Study IDs Children With AOM Who Benefit From Antibiotics

Troy Brown

August 08, 2017

As many as half of children with acute otitis media (AOM) recover without antimicrobials, but it has been difficult to identify those children who are well-suited for initial observation. Now, a study, published online August 8 in Pediatrics shows that children who have severe bulging of the tympanic membrane are those most likely to benefit from the drugs.

"Our main finding is that children with severe bulging of the tympanic membrane, regardless of the laterality of AOM, seem to benefit most from antimicrobial treatment. On the other hand, children with peaked tympanogram (A and C curves) may be optimal candidates for initial observation strategy," write Paula A. Tähtinen, MD, from the Department of Paediatrics and Adolescent Medicine and the Department of Clinical Microbiology at the University of Turku, Finland, and colleagues.

"[O]n the basis of our results, all young children with severe bulging of the tympanic membrane seem to benefit from antimicrobial treatment regardless of the severity of their symptoms or the number of ears infected," they write.

A previous meta-analysis of six individual studies determined that children younger than age 2 years with bilateral AOM and those with otorrhea derived the most benefit from antimicrobial treatment, and the American Academy of Pediatrics relied heavily on this study for its 2014 guideline on the diagnosis and management of AOM.

"The new guideline emphasizes stringent diagnostic criteria for AOM and offers an initial observation option for children <2 years of age with nonsevere unilateral AOM and for all children >2 years of age with nonsevere AOM. However, it was concluded that the most efficient and acceptable methods of initial observation should be studied to establish the balance between benefits and potential risks to the child," the researchers explain.

Therefore, to identify children who are suitable for observation, the authors conducted a preplanned secondary analysis of a randomized controlled trial that had tested amoxicillin-clavulanate (40/5.7 mg/kg per day) or placebo for 7 days in children aged 6 to 35 months.

Three criteria were used to diagnose and identify children eligible for the trial. First, fluid had to be detected in the middle ear by pneumatic otoscopy that showed two or more of the following tympanic membrane findings: bulging position, decreased or absent mobility, abnormal color or opacity not because of scarring, or air–fluid interfaces.

Second, one or more of the following signs of acute inflammation had to be present on the tympanic membrane: distinct patches of erythema, streaks, or increased vascularity over a full, bulging, or yellow tympanic membrane.

Finally, the child had to exhibit acute symptoms, including fever, ear pain, or respiratory symptoms.

Treatment failure, the primary outcome, occurred in 101 (31.7%) of all 319 children. Older age (24 - 35 months; hazard ratio, 0.53; 95% confidence interval [CI], 0.29 to 0.96; P = .04) and peaked tympanogram at entry decreased the hazard for treatment failure (hazard ratio, 0.43; 95% CI, 0.21 - 0.88; P = .02).

When examined by treatment group, 18.6% of children in the antimicrobial group had treatment failure compared with 44.9% of those in the placebo group.

None of the prognostic markers were associated with treatment failure among the antibiotic-treated patients. However, "[t]he percentage-point difference in treatment failure between the antimicrobial treatment and placebo groups was highest among children with severe bulging of the tympanic membrane (11.1% vs 64.1%; rate difference −53.0%; 95% CI, −73.5% to −32.4%), resulting in an [number needed to treat] of 1.9," the researchers write.

"This [number needed to treat] is much lower than the one presented in the recent Cochrane Review in which the authors concluded that 20 children need to be treated to prevent residual pain at 2 to 3 days in 1 child," they continue.

In addition, they say their findings make mechanistic sense, as the bulging membrane has been associated with pathogenic bacteria in the middle ear.

The authors have disclosed no relevant financial relationships.

Pediatrics. Published online August 8, 2017. Abstract

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