Predicting Treatment Failure in Kids With AOM

William T. Basco, Jr., MD


November 27, 2017

Predicting Treatment Failure in Young Children With Acute Otitis Media

Current guidelines[1] suggest that an initial observation period ("watchful waiting") is an option for children younger than 2 years with nonsevere acute otitis media (AOM), an option that is not appropriate for those young children with severe disease. Now, a new study[2] adds details about which young children with AOM might actually benefit from antibiotic therapy

Tähtinen and colleagues[3] reported findings from a preplanned secondary analysis of a randomized, double-blind, placebo-controlled AOM treatment trial in Finland. Study children were aged 6-35 months and had been diagnosed with AOM using standard criteria (presence of middle ear fluid, signs of acute inflammation, and acute symptoms such as fever, ear pain, or respiratory symptoms). The patients' symptoms, medical histories, and demographic information were recorded at enrollment. All examinations were conducted by one of five study physicians who demonstrated excellent agreement on the presence or absence of AOM.

The children were re-evaluated at 48-72 hours after enrollment to determine whether initial therapy had been a success or a failure. In those in whom initial treatment failed, rescue therapy was initiated with amoxicillin-clavulanate. The definition of treatment failure used in the study included the following outcomes:

  • No improvement (or a worsening condition) by day 3 of treatment;

  • Lack of improvement on otoscopy by day 8;

  • Perforation of the tympanic membrane;

  • Development of a severe infection; and

  • Adverse event related to the study drug.

Potential prognostic factors for treatment failure. The study also evaluated the children for 14 potential prognostic factors thought to be associated with AOM treatment failure:

  • Child's age (6-23 months or 24-35 months);

  • History of recurrent AOM;

  • Presence of bilateral otitis media;

  • Severe bulging of the tympanic membrane;

  • "Peaked" (vs "flat") tympanogram (A, C1, or C2 curve);

  • Fever ≥38°C;

  • Ear pain;

  • Ear rubbing;

  • Decreased activity;

  • Nasopharyngeal Staphylococcus pneumoniae;

  • Nasopharyngeal Haemophilus influenzae;

  • Nasopharyngeal Moraxella catarrhalis;

  • Nasopharyngeal respiratory virus; and

  • Severe illness (moderate or severe ear pain or fever ≥39°C).


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