EFFECTIVENESS OF 5 DAYS OF THERAPY WITH CEFUROXIME AXETIL SUSPENSION FOR TREATMENT OF ACUTE OTITIS-MEDIA

Background, In recent years there has been considerable interest in re ducing the duration of antibiotic treatment regimens in patients with common bacterial infections, We conducted two independent, investigato r-blinded, multicenter, randomized clinical trials, one of which inclu ded microbiologic evaluation of middle ear fluid obtained by tympanoce ntesis, comparing the efficacy and safety of 5 or 10 days of treatment with cefuroxime axetil suspension (CAE) with that of 10 days of treat ment with amoxicillin/clavulanate suspension (AMX/CL) in children with acute otitis media, Methods. A total of 719 pediatric patients from t he ages of 3 months to 12 years were enrolled in the 2 studies, Patien ts received CAE for either 5 or 10 days at 30 mg/kg/day in 2 divided d oses (n = 242 and 235, respectively) or AMX/CL for 10 days at 40 mg/kg /day in 3 divided doses (n = 242), Patients in the CAE (5 days) group received placebo on Days 6 through 10, In the study that included tymp anocentesis, bacteriologic assessments were based on middle ear fluid cultures obtained pretreatment and, when possible, after treatment in patients with an unsatisfactory clinical outcome, Results, Organisms w ere isolated from the pretreatment middle ear fluid specimens of 177 o f 244 (73%) patients undergoing tympanocentesis, with the primary path ogens being Streptococcus pneumoniae, Haemophilus influenzae and Morax ella catarrhalis (37, 35 and 12% of isolates, respectively), Pathogens were eradicated or presumed to be eradicated in 92% (24 of 26), 84% ( 32 of 38) and 95% (36 of 38) of bacteriologically evaluable patients t reated with CAE for 5 or 10 days or with AMX/CL, respectively, A satis factory clinical outcome (cure or improvement) occurred in 69% (101 of 147), 70% (121 of 173) and 74% (131 of 177) of clinically evaluable p atients treated with CAE (5 days), CAF, (10 days) or AMX/CL, respectiv ely, Treatment with AMX/CL was associated with a significantly higher incidence of drug-related adverse events than was treatment with CAF, for either 5 or 10 days (P < 0.001), primarily reflecting a higher inc idence of drug-related gastrointestinal adverse events (34% vs, 17 and 12%, respectively; P < 0.001), particularly diarrhea, Conclusions, Tr eatment with CAE given twice daily for 5 days is equivalent to treatme nt for 10 days either with the same regimen of CAE or with AMX/CL give n three times daily in pediatric patients with acute otitis media.