Cefixime, a new
third generation cephalosporin antibiotic for oral use, was evaluated for safety and efficacy in the treatment of children with acute
otitis media with effusion. Fifteen United States clinical investigators participated in the multicenter clinical trial. One hundred twenty children were randomly assigned to a 10-day course of either
cefixime, 8 mg/kg, given daily (qd) (60 patients) or
amoxicillin, 40 mg/kg/day, administered in three divided doses (60 patients). Tympanocentesis was performed on each patient before
therapy was initiated. Pathogens were isolated from a middle ear aspirate in 88% of the cases. Of the specimens from which pathogens were cultured, 33% yielded Haemophilus sp., 41% Streptococcus pneumoniae and 6% Branhamella catarrhalis. Of the 120 patients, 64 (30
cefixime and 34
amoxicillin) were evaluable for assessment of efficacy. Favorable clinical responses (cure or improvement) were obtained in 93% of
cefixime-treated patients and in 94% of
amoxicillin-treated patients. Overall, bacteriologic eradication rates (as determined by clinical criteria) were 94 and 95%, respectively. Clinical failure or relapse was documented in 2 of 30 (7%) patients treated with
cefixime and in 2 of 34 (6%) patients treated with
amoxicillin. Gastrointestinal disturbance and
rash were significantly more common in children treated with
cefixime (22 and 15%, respectively) than in those taking
amoxicillin (8 and 2%, respectively), but in only one case was it necessary to discontinue medication because of these adverse effects (
rash). Results of this study demonstrate that
cefixime given once daily is as safe and effective as
amoxicillin in the treatment of acute
otitis media with effusion in children and has the possible advantage of less frequent dosing.