TWICE-DAILY CEFPODOXIME PROXETIL COMPARED WITH THRICE DAILY AMOXICILLIN-CLAVULANIC ACID FOR TREATMENT OF ACUTE OTITIS-MEDIA IN CHILDREN

A total of 260 children, 3 months to 11 years old (median age 24 months), with acute otitis media (AOM) received either cefpodoxime proxetil (CP) 8 mg/kg/d b.i.d. or amoxicillin/clavulanic acid (ACA) 40/10 mg/kg/d t.i.d. for 8 days. A significant difference in clinical cure rates was observed between the CP group 71/118 (60%) and the ACA group 42/105 (40%), p = 0.003. At the follow-up visit (20-30 days after the start of treatment), significant advantages were recorded with the CP vs. ACA therapy, in terms of satisfactory clinical response [90/111 (81%) vs 60/94 (63.8%), p = 0.005] residual middle ear effusion (14.4% vs 28.7%, p = 0.01) and normal tympanometry (78% vs 61.4%, p = 0.017). Compliance and adverse event frequency were the same in both treatment groups. The higher clinical cure rate and equivalent safety profile of CP indicates that it is an acceptable alternative to ACA for the treatment of AOM in children.