Acute otitis media in children: a study of nasopharyngeal carriage of potential pathogens and therapeutic efficacy of cefixime and amoxicillin-clavulanate.

We conducted a large, multicenter, randomized, open-label study throughout France comparing the efficacy and safety of cefixime suspension (8 mg/kg/day, b.i.d., for 10 days) versus amoxicillin-clavulanate suspension (80 mg/kg/day, t.i.d., for 10 days) in 510 children (ages 6 to 36 months) with acute otitis media. The most frequent microorganisms colonizing the nasopharynx at the start of treatment were Streptococcus pneumoniae (51.5%), Haemophilus influenzae (45%) and Moraxella catarrhalis (30.2%). Rates of beta-lactamase positivity were 32.1% and 95.3% for H. influenzae and M. catarrhalis, respectively. Decreased susceptibility of S. pneumoniae to penicillin was found in 39.7% of isolates. Clinical efficacy was 87.8% (223/254) for cefixime and 87.0% (215/247) for amoxicillin-clavulanate. At the 5-week follow-up visit, relapse had occurred in 15.7% (31/197) of cefixime-treated patients and in 15.6% (32/205) of those treated with amoxicillin-clavulanate. We conclude that these two regimens are equally effective in acute otitis media in children.

RCT Entities:   Population Interventions Outcomes