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Abstract
Two independent, investigator-blinded, multicenter, randomized clinical trials, one
of which included microbiologic evaluation of middle-ear fluid obtained by use of
tympanocentesis, compared the efficacy and safety of two oral antibiotics, cefuroxime
axetil suspension and amoxicillin/clavulanate suspension, in the treatment of children
3 months to 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 receive 10 days of treatment with either
cefuroxime axetil suspension 30 mg/kg per day in two divided doses (n = 235) or amoxicillin/clavulanate
suspension 40 mg/kg per day in three divided doses (n = 242). Patients were assesed
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 pretreatment,
and, when possible, posttreatment in patients with an unsatisfactory clinical outcome.
Organisms were isolated from the pretreatment middle-ear fluid specimens of 120 (73%)
of 164 patients undergoing tympanocentesis, 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 isolates and 94% of the M catarrhalis isolates that were tested for beta-lactamase production were positive. A satisfactory
clinical outcome (cure or improvement) was obtained in 70% (121 of 173) and 74% (131
of 177) of clinically assessable patients treated with cefuroxime axetil or amoxicillin/clavulanate,
respectively (P = 0.40). With respect to the eradication of bacterial pathogens, in the study that
included tympanocentesis 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, respectively (P = 0.26). Treatment with amoxicillin/clavulanate was associated with a significantly
higher incidence of drug-related adverse events than was treatment with cefuroxime
axetil (37% vs 16%; P < 0.001), primarily reflecting a higher incidence of drug-related gastrointestinal
adverse events (34% vs 12%; P < 0.001), particularly diarrhea. Eight patients in the cefuroxime axetil group and
11 patients in the amoxicillin/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/clavulanate suspension 13.3 mg/kg
three times daily in the treatment of pediatric patients with AOME, but produces fewer
gastrointestinal adverse events, particularly diarrhea.
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© 1995 Published by Elsevier Inc.
