EFFICACY OF CEFTIBUTEN COMPARED WITH AMOXICILLIN FOR OTITIS-MEDIA WITH EFFUSION IN INFANTS AND CHILDREN

Objectives, This trial compared the efficacy of ceftibuten with that o f amoxicillin in resolving otitis media with effusion, Methods. Two hu ndred ten children with otitis media with effusion were randomly assig ned to receive either ceftibuten (9 mg/kg/day in one daily dose) or am oxicillin (40 mg/kg/day divided into 3 daily doses) for 14 days. Outco me was assessed at 2 and 4 weeks in all subjects; those without middle ear effusion at the 4-week visit were examined at 8, 12 and 16 weeks, Middle ear status was determined by pneumatic otoscopy and by an algo rithm combining pneumatic otoscopy with tympanometry. Results, The per centages of subjects who were effusion-free in the ceftibuten and amox icillin groups at 2 weeks by otoscopy were 29.8 and 27.2%, respectivel y (P = 0.59), and by the algorithm, 23.4 and 20.4%, respectively (P = 0.47), In children who were effusion-free at 2 weeks, recurrence of ef fusion by 16 weeks was noted in approximately 60% of the ceftibuten gr oup and 67% of the amoxicillin group, No medication side effects were reported by 88% of subjects in the ceftibuten group and by 93% of subj ects in the amoxicillin group, We found no significant differences bet ween the ceftibuten and amoxicillin groups with respect to resolution of middle ear effusion, rate of recurrence or side effects, Conclusion s, Amoxicillin remains the drug of first choice for treatment of otiti s media with effusion when treatment is deemed advisable, but ceftibut en may be an alternative drug in selected situations.