COMPARISON OF CEFUROXIME AXETIL AND AMOXICILLIN-CLAVULANATE SUSPENSIONS IN TREATMENT OF ACUTE OTITIS-MEDIA WITH EFFUSION IN CHILDREN

Two hundred sixty-three pediatric patients from the ages of 3 months t o 11 years were enrolled in a randomized, investigator-blinded, multic enter study comparing the clinical and bacteriological efficacies and safety of cefuroxime axetil suspension (CAE) with those of amoxicillin -clavulanate suspension (AMX-CL) in the treatment of acute otitis medi a with effusion. Patients received CAE at 30 mg/kg of body weight per day (n = 165) in two divided doses or AMX-CL at 40 mg/kg/day (n = 98) in three divided doses for 10 days. The primary pathogens among 200 is olates from pretreatment cultures of middle ear fluid were identified as follows: Haemophilus influenzae (39%), over a third of which were b eta-lactamase positive; Streptococcus pneumoniae (34%); and Moraxella catarrhalis (16%). Pathogens were eradicated or presumed to be eradica ted from 81% (95 of 118) and 76% (50 of 66) of bacteriologically evalu able patients in the CAE and AMX-CL groups, respectively. A satisfacto ry clinical response (cure or improvement with or without resolution o f effusion) occurred in 113 (77%) of 146 clinically evaluable patients in the CAE group and in 66 (74%) of 89 evaluable patients in the AMX- CL group. Clinical failure or recurrence (within 2 weeks following the completion of treatment) occurred in 22 and 26% of CAE- and AMX-CL-tr eated patients, respectively. Drug-related adverse events occurred in 18% of CAE-treated patients, whereas they occurred in 39% of AMX-CL-tr eated patients (P<0.001); diarrhea or loose stools was the most common ly reported adverse event (CAE, 12%; AMX-CL, 31%; P<0.001). These resu lts indicate that CAE given t-vvice daily is as effective as AMX-CL gi ven three times daily in the treatment of acute otitis media with effu sion in pediatric patients, but CAE was associated with significantly fewer drug-related adverse events.