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 throug hout France comparing the efficacy and safety of cefixime suspension ( 8 mg/kg/day, b. i. d., for 10 days) versus amoxicillin-clavulanate sus pension (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 microorganism s colonizing the nasopharynx at the start of treatment were Streptococ cus pneumoniae (51.5%), Haemophilus influenzae (45%) and Moraxella cat arrhalis (30.2%). Rates of beta-lactamase positivity were 32.1% and 95 .3% for H. influenzae and M. catarrhalis, respectively. Decreased susc eptibility of S. pneumoniae to penicillin was found in 39.7% of isolat es. Clinical efficacy was 87.8% (223/254) for cefixime and 87.0% (215/ 247) for amoxicillin-clavulanate. At the 5-week follow-up visit, relap se had occurred in 15.7% (31/197) of cefixime-treated patients and in 15.6% (32/205) of those treated with amoxicillin-clavulanate. We concl ude that these two regimens are equally effective in acute otitis medi a in children.