CEFPODOXIME PROXETIL 5 DAYS VERSUS CEFIXIME 8 DAYS IN THE TREATMENT OF ACUTE OTITIS-MEDIA IN CHILDREN

A prospective, randomized, multicentric French study was conducted by 41 general practionners (GP) and 8 ENT specialists in order to evaluate the efficacy and tolerance of cefpodoxime-proxetil (CPD) versus cefixime (CFM), in the treatment of infant's and children's acute otitis media (AOM). 245 patients with painful and febrile AOM were included (CPD : 124, CFM : 121) receiving after randomisation either CPD 4 mg/kg bid for 5 days or CFM 4 mg/kg bid for 8 days. At the end of treatment, by intention to treat analysis (n = 245), the clinical results were satisfactory (cure or improvement without necessity of new prescription of antibiotics or surgical ENT procedure) in 94 % (116/124) in the CPD group versus 93 % (113/121) in the CFM group with rejection of inequivalence : p < 0,001. These results were confirmed by per protocol analysis (n = 227). At the follow-up visit, the equivalence of efficacy of CPD 5 days compared to CFM 8 days was sustained, with by intention to treat analysis (n = 234) : 79 % (94/119) success in the CPD group versus 74 % (85/115) in the CFM group., The tolerance was good with 5,6 % (7/124) of side effects imputable to CPD versus 6,6 % (8/121) in the CFM group (mainly gastrointestinal). Cefpodoxime-proxetil? with a shortened duration of 5 days treatment, was as efficient as cefixime with an 8 days course, at end of treatment as well as at the follow-up visit.