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Which otitis media patients can be treated without antimicrobial agents?

Jairia Dela Cruz
31 Aug 2017

In children with acute otitis media (AOM), antimicrobial treatment may be most beneficial in the presence of severe bulging of the tympanic membrane and be withheld in patients with peaked tympanogram, according to a study.

Performing a secondary analysis of a trial involving 319 children with AOM aged 6 to 35 months (median 14 months; 57.1 percent male) randomized to receive amoxicillin-clavulanate (40/5.7 mg/kg per day) or placebo for 7 days, a team of Finland-based investigators found that the primary outcome of treatment failure occurred in 31.7 percent of patients. [Pediatrics 2017;doi:10.1542/peds.2017-0072]

The greatest difference in treatment failure rate between the antimicrobial and placebo groups was seen among children with severe bulging of the tympanic membrane (11.1 vs 64.1 percent, respectively; rate difference, −53.0 percent; 95 percent CI, −73.5 to −32.4), yielding a number needed to treat of 1.9.

Older age (24 to 35 months) and peaked tympanogram (A and C curves) at entry particularly reduced the risk of treatment failure by 47 and 57 percent, respectively (hazard ratio [HR] with older age, 0.53; 0.29 to 0.96; p=0.04; HR with peaked tympanogram, 0.43; 0.21 to 0.88; p=0.02).

“The interaction between bulging of the tympanic membrane and treatment group suggested that the effect of antimicrobial treatment varies depending on the severity of bulging,” the investigators noted.

They explained that the finding that children with severe bulging benefit most from antimicrobial treatment, which is in agreement with a previous study, is “logical because bulging of the tympanic membrane has been shown to be associated with the presence of a bacterial pathogen in the middle ear.” [N Engl J Med 2011;364:105–115; Clin Infect Dis 2004;38:234–242]

However, symptoms are not specific to AOM, often overlapping with those of concurrent viral respiratory tract infection, especially among preverbal children, the investigators said. This may explain the important observation of lack of association between pre-existing symptoms and treatment outcome.

“Children classified as having severe illness according to the AOM treatment guideline by the American Academy of Pediatrics (ie, moderate or severe ear pain or fever ≥39°C) encountered treatment failure as often as children with nonsevere illness,” they pointed out.

“Therefore, it could be questioned whether the AOM treatment decisions should be based solely on symptom severity. In the resolution of AOM, however, symptoms play an important role. We had a close follow-up schedule and examined every child at our study clinic on days 3 and 8,” they continued.

Then again, the investigators acknowledged that the said close follow-up is not feasible in clinical practice, with the current recommendation of a revisit only if symptoms do not improve within 2 to 3 days being both safe and reasonable.

Given the utility of tympanometry in determining which children could be treated without antimicrobial agents and despite the presence of several limitations, findings of the present study are said to be directly applicable in clinical practice.

“By withholding antimicrobial treatment from children with peaked tympanogram (A and C curves), the use of antimicrobial agents and the development of antimicrobial resistance could be reduced without increasing the risks for the child,” the investigators said.

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