Acute otitis media in children frequently requires antibiotic prescriptions. Although acute otitis media usually resolves spontaneously, antibiotic treatment is prescribed to prevent complications such as mastoiditis or meningitis. The antibiotic will also decrease the chance of hearing loss and permanent damage to the middle ear and will relieve symptoms. Resistance to pathogens that cause acute otitis media, including Streptococcus pneumoniae–resistance to penicillins and macrolide antibiotics, is occurring in many countries. Alternative therapies have included ceftriaxone, a third-generation cephalosporin with a spectrum of antibacterial activity, including most of the common pathogens of acute otitis media. Cohen and associates compared the efficacy and safety of a single intramuscular dose of ceftriaxone with a 10-day course of oral amoxicillin-clavulanate potassium treatment in infants and children with acute otitis media.

Children between the ages of four months and 30 months with acute otitis media (indicated by the presence of an effusion and marked redness or bulging, or moderate redness and bulging associated with fever, otalgia, irritability or any combination of these symptoms) were included in the study group. Children who had recently taken antibiotics or who had a known hypersensitivity to betalactam antibiotics or a severe underlying disease were excluded from participation. Study subjects were randomly assigned to receive either a single intramuscular dose of ceftriaxone, 50 mg per kg, or amoxicillin in a dosage of 80 mg per kg per day and clavulanate potassium in a dosage of 10 mg per kg in three divided doses daily for 10 days. Symptoms were followed, as were post-treatment changes in the presence of S. pneumonia, Haemophilus influenzae and Moraxella catarrhalis in the nasopharynx.

Clinical response was similar in both groups. There was no evidence that treatment with ceftriaxone contributed more to the emergence of resistance than 10 days of treatment with an oral antibiotic. Adverse effects, including gastrointestinal symptoms, were significantly higher in the amoxicillin-clavulanate potassium group.

The authors conclude that in young children, the population less likely to have spontaneous recovery after acute otitis media, treatment with a single dose of ceftriaxone is clinically equivalent to 10 days of treatment with amoxicillin-clavulanate potassium. Ceftriaxone therapy is well-suited for use in children who have compliance problems, decreased oral absorption because of vomiting, high fever or possible concurrent bacteremias.