Two hundred sixty-three pediatric patients from the ages of 3 months to 11 years were enrolled in a randomized, investigator-blinded, multicenter study comparing the clinical and bacteriological ellicacies and safety of cefuroxime axetil suspension (CAE) with those of amoxicillin-clavulanate suspension (AMX-CL) in the treatment of acute otitis media 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 isolates from pretreatment cultures of middle ear fluid were identified as follows: Haemophilus influenzae (39%o), over a third of which were P-lactamase positive; Streptococcus pneumoniae (34%); and MoraxeUla catarrhalis (16%). Pathogens were eradicated or presumed to be eradicated from 81% (95 of 118) and 76% (50 of 66) of bacteriologically evaluable patients in the CAE and AMX-CL groups, respectively. A satisfactory clinical response (cure or improvement with or without resolution of 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-treated patients, respectively. Drug-related adverse events occurred in 18% of CAE-treated patients, whereas they occurred in 39%o of AMX-CL-treated patients (P < 0.001); diarrhea or loose stools was the most commonly reported adverse event (CAE, 12%; AMX-CL, 31%; P < 0.001). These results indicate that CAE given twice daily is as effective as AMX-CL given three times daily in the treatment of acute otitis media with elfusion in pediatric patients, but CAE was associated with significantly fewer drug-related adverse events.
Purulent conjunctivitis associatedwith otitis media was studied in 124 patients in a private practice over a period of one year. Of the 132 patients seen with purulent conjunctivitis, 96 (73%) concurrently had otitis media. In 28 (47%) of 60 families with more than one child, siblings of the index cases had either purulent conjunctivitis or otitis media, or both, simultaneously or within one month. During the study period, conjunctival cultures were obtained from 75 patients with purulent conjunctivitis-otitis media and patients with purulent conjunctivitis whose siblings had purulent conjunctivitis-otitis media or otitis media. Haemophilus influenzae was isolated from 55 (73%). Thirty-one of the patients had nasal cultures done simultaneously with conjunctival cultures. An identical pathogen was isolated from 27 (87%) patients.
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