Antibiotics Recommended for All Toddlers with Ear Infections

A team of researchers has recommended that all cases of acute otitis media in children aged 6 months to 2 years be treated with antibiotics, disagreeing with guidelines from the American Academy of Pediatrics.

In a research letter published online on September 2, 2013, in JAMA Pediatrics, researchers recommend that all children aged 6 months to 2 years diagnosed with acute otitis media be treated with antibiotics, despite recent guidelines from the American Academy of Pediatrics (AAP) that recommend otherwise.

Guidelines released by the AAP in March 2013 recommend that children aged 6 months to 2 years diagnosed with acute otitis media without severe signs or symptoms and those with a unilateral infection be observed without initial antimicrobial treatment. For children with bilateral and severe infections, the AAP recommends treatment with antibiotics. These recommendations were based on the results of clinical trials indicating that antibiotics provided little benefit for children with one-sided and mild ear infections.

However, the authors of the research letter argue that some children enrolled in the trials used to formulate the AAP guidelines may not have actually had otitis media, given that the criteria used to diagnose their participants were less strict than those specified in the AAP guidelines. To evaluate the guidelines, the researchers, based at the University of Pittsburgh School of Medicine and Turku University Hospital in Finland, analyzed data from 2 previously published studies with strict requirements for diagnosing infections.

These blind trials, conducted in Pittsburgh, Pennsylvania, and Turku, Finland, randomly assigned young children diagnosed with acute otitis media to receive either amoxicillin—clavulanate potassium or placebo. In the Pittsburgh study, treatment failure was defined as lack of substantial improvement in symptoms or otoscopic signs 4 to 5 days after initiation or incomplete resolution of symptoms after 10 to 12 days. Treatment failure in the Turku trial was defined as lack of any improvement 3 days after beginning treatment, lack of improvement in otoscopic signs after 8 days, or worsening symptoms, tympanic membrane perforation, or medication discontinuation at any time. The results of both trials were combined for analysis.

Overall, the researchers found that treatment failure rates were significantly higher in the placebo group than in the antibiotic group and were similar among children with severe and non-severe infections and children with unilateral and bilateral infections. Antibiotic treatment failed in 14% of unilateral, non-severe cases, and in 25% of bilateral, severe cases. Placebo failed in 40% of unilateral, non-severe infections, and in 59% of bilateral, severe infections.

The authors conclude that their findings support a “uniform approach to antimicrobial treatment in children younger than 2 years with stringently diagnosed [acute otitis media].” They suggest that the AAP recommendations be changed to recommend antibiotics for children with unilateral and mild acute otitis media.