CLINICAL COMPARISON OF CEFUROXIME AXETIL SUSPENSION AND AMOXICILLIN CLAVULANATE SUSPENSION IN THE TREATMENT OF PEDIATRIC-PATIENTS WITH ACUTE OTITIS-MEDIA WITH EFFUSION/

Two independent, investigator-blinded, multicenter, randomized clinica l. trials, one of which included microbiologic evaluation of middle-ea r fluid obtained by use of tympanocentesis, compared the efficacy and safety of two oral antibiotics, cefuroxime axetil suspension and amoxi cillin/clavulanate suspension, in the treatment of children 3 months t o 12 years old diagnosed with acute otitis media with effusion (AOME). Four hundred seventy seven pediatric patients with signs and symptoms of AOME were enrolled at 20 centers and were randomly assigned to rec eive 10 days of treatment with either cefuroxime axetil suspension 30 mg/kg per day in two divided doses (n = 235) or amoxicillin/clavulanat e suspension 40 mg/kg per day in three divided doses (n = 242). Patien ts were assessed for their response to treatment once during treatment (at 3 to 5 days) and twice after treatment (at 1 to 4 days and at 14 to 18 days). In the study that included tympanocentesis, bacteriologic assessments were based on middle-ear fluid cultures obtained pretreat ment, and, when possible, posttreatment in patients with an unsatisfac tory clinical outcome. Organisms were isolated from the pretreatment m iddle-ear fluid specimens of 120 (73%) of 164 patients undergoing tymp anocentesis, with the primary pathogens being Streptococcus pneumoniae , Haemophilus influenzae, and Moraxella catarrhalis (27%, 24%, and 6% of isolates, respectively). Forty four percent of the H influenzae iso lates and 94% of the M catarrhalis isolates that were tested for beta- lactamase production were positive. A satisfactory clinical outcome (c ure or improvement) was obtained in 70% (121 of 173) and 74% (131 of 1 77) of clinically assessable patients treated with cefuroxime axetil o r amoxicillin/clavulanate, respectively (P = 0.40). With respect to th e eradication of bacterial pathogens, in the study that included tympa nocentesis a satisfactory outcome (cure or presumed cure) was obtained in 84% (32 of 38) and 95% (36 of 38) of bacteriologically assessable patients treated with cefuroxime axetil or amoxicillin/clavulanate, re spectively (P = 0.26). Treatment with amoxicillin/clavulanate was asso ciated with a significantly higher incidence of drug-related adverse e vents than was treatment with cefuroxime axetil (37% vs 16%; P < 0.001 ), primarily reflecting a higher incidence of drug-related gastrointes tinal adverse events (34% vs 12%; P < 0.001), particularly diarrhea. E ight patients in the cefuroxime axetil group and 11 patients in the am oxicillin/clavulanate group withdrew from the studies because of drug- related adverse events. These results indicate that cefuroxime axetil suspension 15 mg/kg twice daily is as effective as amoxicillin/clavula nate suspension 13.3 mg/kg three times daily in the treatment of pedia tric patients with AOME, but produces fewer gastrointestinal adverse e vents, particularly diarrhea.