CEFPODOXIME PROXETIL VS CEFIXIME FOR PAINFUL FEBRILE ACUTE OTITIS-MEDIA IN CHILDREN

This open-label multicenter trial compared the efficacy of cefpodoxime proxetil (CPD) oral suspension with that of cefixime (CFX) granules, both at a dosage of 8 mg/kg/day in two fractions for 8 days, in children aged from 6 months to 6 years with acute otitis media (AOM) with effusion. Pain and fever (greater-than-or-equal-to 38,4-degrees-C) were used as inclusion criteria with the aim of selecting cases due to Streptococcus pneumoniae (Sp). To avoid equalizing the results in the two groups, initial paracentesis was not performed, but validated clinical inclusion criteria (Paradise) were used. Randomization was done by means of a centralized telematic system. The main end-point was the comparative failure rate at the end of treatment, as assessed by two independent observers who were unaware of the treatment allocation. Improvements and cures were considered as treatment successes. 146 children seen as outpatients (CPD = 72; CFX = 74) by 14 pediatricians and two ENT specialists were enrolled between September 1991 and May 1992. 144 children were evaluable for tolerability and 140 for clinical efficacy at the end of treatment (D9-11); 143 children were included in the intention-to-treat analysis of clinical efficacy (D15). There were 75 boys and 69 girls with a mean age of 24.3 months (+/- 16.6) and a mean bodyweight of 11.8 kg (+/- 3.6). A bacteriological rhinopharangeal sample taken at inclusion yielded Sp in 66,4 % of cases, 44,8 % of which had a 5-mug oxacillin disk inhibition zone diameter of less-than-or-equal-to 25 mm. The penicillin MIC values confirmed the diminished susceptibility of 34,4 % of isolates (0,125 less-than-or-equal-to MIC less-than-or-equal-to 1 mg/l in 18,8 %, MIC > 1 mg/l in 15.6 %). At the end of treatment, there where 8/69 failures (11,6 %) in the CPD group, and 19/71 (26,7 %) in the CFX group (p = 0,023). The respective figures in the intention-to-treat analysis were 11/71 (15,5 %) and 21/72 (29,1 %) (p = 0,049). At the follow-up examination (D30-45), 10/49 patients (20,4 %) in the CDP group has relapsed, compared to 9/47 (19,1 %) in the CFX group (NS). The proportion of patients with side effects was 12,7 % on CPD and 15, 1 % on CFX (NS). Treatment was stopped twice in each group because of side effects. No serious adverse events occured. In conclusion, CPD was significantly more effective (88,4 %) than CFX (73,3 %) in these children with painful febrile acute otitis media.