Treatment of acute bacterial maxillary sinusitis in adult outpatients:: comparison of a 5 versus 10 days course of cefpodoxime proxetil

Objective: The aim of this multicentric, randomized, double blind study was to compare the efficacy and safety of cefpodoxime, proxetil (CPD) administered over a 5-d or a 10-d period in adults suffering from acute maxillary sinusitis. Patients and methods: Adult patients suffering from radiologically confirmed acute maxillary sinusitis (at least purulent rhinorrhea and facial pain) were included. Patients were randomly treated with CPD (200 mg, bid) over a 5-d period followed by 5 d of placebo, or with CPD (200 mg, bid) over a 10-d period. Results: 491 patients (282-from France and 209 from South Africa) were included in the study between January and October 2000. In the per protocol analysis, the clinical cure rates at the end of treatment (D12-D15) were 95.4% (185/194) and 91.2% (196/215) in the 5-d and 10-d group, respectively; delta = 4.2%, 95%CI: [-0.6; 9%]. Bacteriological cultures were positive in 48% of the patients. The most common pathogens were Streptococcus pneumoniae (30.5%) and Haemophilus influenzae (25.5%). All the patients infected with penicillin-resistant pneumococci (n = 13) were cured. The bacteriological cure rates at D12-D15 were 90.7% (78/86) in the 5-d group and 92.8% (103/111) in the 10-d group. 2 weeks after completing treatment (D25-D30), the clinically cure rates were 90.7% (176/194) and 82.8% (178/215) in the 5-d and 10-d group, respectively. The lack of adverse effects of CPD was confirmed in both groups. Conclusions: A 5-d course of cefpodoxime proxetil 200 mg bid is as effective as a 10-d course in the treatment of acute maxillary sinusitis in adults. (C) 2002 Editions scientifiques et medicales Elsevier SAS. All rights reserved.