Treatment of acute maxillary sinusitis in adult outpatients: comparison ofa five versus ten day-course of cefuroxime axetil

Objective - The aim of this double blind, randomized, multicenter study car ried out by 78 ENT specialists was to demonstrate that the two regimens (fi ve days versus ten days) of cefuroxime axetil 250 mg twice daily present th e same clinical efficacy in adults with acute maxillary sinusitis. Patients and methods - Diagnosis of sinusitis was defined as at least two o f the following symptoms (purulent rhinorrhea, nasal congestion, headache, facial pain), and radiologically confirmed by an expert committee. Clinical efficacy, defined as success (cure or improvement) or failure, was assesse d at the end of treatment (days 12-14) and on follow-up (days 21-28). A tot al of 401 patients (206 for the 5-day group, 195 for the 10-day group) were randomized between January 1997 and January 1998. All patients were assess ed for safety analysis, intent-to-Treat and Per-Protocol analysis. Results - The most commonly isolated pre-treatment pathogens were S. pneumo niae (n = 60), H. influenzae (n = 56), and M. catarrhalis (n = 22). At the end of treatment, clinical success rates were equivalent, with 85% (176/206 ) in the 5-day group and 87% (169/195) in the 10-day group. The difference in success rates was -1.2% with a 90%CI: [-6.9%; 4.5%]. On follow-up, 51 pa tients experienced a clinical relapse. 25 and 26 patients in the in the ti- day group and 10-day group respectively. Radiological success rate on follo w-up was 68% in the 5-day group and 67% in the 10-day group. Bacteriologica l success rate was 89% and 91% in the 5-day group and 10-day group respecti vely at end of treatment; it was 83% and 78% in the 5-day group and 10-day group respectively on follow-up. No unexpected adverse event was observed a nd both regimens were well tolerated. Conclusion - A 5-day course of cefuroxime 250 mg twice daily is as effectiv e as a 10-day course in the treatment of acute bacterial sinusitis. (C) 200 1 Editions scientifiques et medicates Elsevier SAS.