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Amoxicillin-clavulanate treated symptoms of AOM in young children
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Children with acute otitis media had better symptom response when treated with amoxicillin-clavulanate than those treated with a placebo, according to new study results.
The double blind, randomized, placebo-controlled clinical trial included otherwise healthy children aged younger than 2 years with middle-ear effusion and bulging of the tympanic membrane.
Participants were assigned a 10-day, high-dose amoxicillin-clavulanate drug treatment and acetaminophen for relief of symptoms. Treatment was monitored during a 12-day period, and participants were seen on days 4 or 5 and days 10, 11 or 12.
Researchers found that amoxicillin-clavulanate was more favorable than placebo against clinical failure: days 4 to 5, 4% vs. 23%; and days 10 to 12, 16% vs. 51%.
Alejandro Hoberman
“The magnitude of the difference in outcome between the amoxicillin-clavulanate and placebo groups varied substantially depending on the criteria used for defining clinical failure: absolute between-group difference in the percentage of children with clinical failure ranged from 35% to 12%; the number need to treat, thus, ranged from three to eight,” researchers, including Infectious Diseases in Children Editorial Board member Alejandro Hoberman, MD, said.
They added that the findings “underscore the need to resolve the question of whether symptomatic response or response based on otoscopic findings is the more telling measure of disease outcome.”
Disclosure: The researchers report no relevant financial disclosures.
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