RANDOMIZED TRIAL COMPARING 5-DAY CEFPODOX IME PROXETIL AND 8-DAY AMOXICILLIN-CLAVULANATE TREATMENT OF ACUTE OTITIS-MEDIA IN CHILDREN

This open, multicenter trial compared the efficacy and safety of cefpo doxime proxetil (CPD, oral suspension) dosed at 8 mg/kg/d in two fract ions for 5 days, and an amoxicillin-clavulanate combination (AAC, oral suspension) dosed at 80 mg/kg/d in three fractions for 8 days, in chi ldren with acute otitis media (AOM). The aim of the trial was to compa re rates of satisfactory clinical reponse (cure and improvement). Rhin opharyngeal swabs were obtained at enrollment and at the end of treatm ent. 398 children (199 in each group) referred by 23 community pediatr icians were enrolled and treated between October 1993 and February 199 4. There were 215 boys and 183 girls, with a mean (+/-SD) age of 17.8 +/- 11.0 months and a mean body weight of 10.6 +/- 2.4 kg. In the per protocol analysis, efficacy was satisfactory at the end of treatement in 84.3 % of cases (160/186) in the CPD group and 83.2 % of cases (153 /184) in the AAC group (p=0.45). In the intention-to-treat analysis, s uccess rate on D17 reached 84.3 % (166/197) on CPD and 82.1 % (161/196 ) on AAC (p=0.57). Ar the follow-up assessment on D20-40, relapses wer e observed in 34/140 (24.3 %) of the patients in the CPD and 25/137 (1 8.2 %) of those on AAC (p=0.22). Side effects were significantly more frequent on AAC (41/199, 20.6 %) than on CDP (18/199, 9 %) (p=0.0012). We conclude that the efficacy of a five-day course of CPD in two dail y intakes is not different from that of an 8-day course of AAC in thre e daily intakes, for children with AOM. Nevertheless, side effects are significantly less frequent on CPD.