Ciprofloxacin versus cefuroxime axetil in the treatment of acute bacterialsinusitis

Objective: This study was conducted to compare the efficacy and safety of c iprofloxacin to cefuroxime axetil for the management of acute bacterial sin usitis or acute exacerbations of chronic sinusitis. Method: In this prospective, multicentre, randomized, double-blind clinical trial, 501 adult outpatients seen in 17 otolaryngology offices with both s ymptoms and radiographic evidence of acute maxillary sinusitis randomly rec eived oral ciprofloxacin (500 mg b.i.d.) or cefuroxime axetil (250 mg b.i.d .), each for 10 days. Patients were further subclassified as having either acute sinusitis or an acute exacerbation of chronic sinusitis. All patients underwent maxillary sinus aspiration at study entry to establish a microbi ologic etiology. The primary measure of efficacy was the rate of clinical s uccess in the efficacy-valid population at the end of therapy. Secondary me asures included bacteriologic response at the end of therapy, and 2- to 4-w eek clinical and bacteriologic follow-up response rates in both efficacy-va lid and intent-to-treat groups. Results: Haemophilus influenzae (21%), Streptococcus pneumoniae (19%), Mora xella catarrhalis (14%), and Staphylococcus aureus (9%) were the most commo nly isolated pathogens (target organisms) among the 225 causative organisms identified from 189 patients. Of 453 adults valid for clinical efficacy (2 28 ciprofloxacin, 225 cefuroxime axetil), ciprofloxacin treatment was stati stically equivalent to cefuroxime axetil at the end of treatment (87% vs. 8 3%; CI95 = -0.021...0.106) and at follow-up (91% vs. 88%; CI95 = -0.044...0 .080). The clinical response was similar for subgroups of patients with pos itive cultures, including the subset with target organisms. Bacteriologic e radication at end of therapy was similar between the two groups (97% ciprof loxacin, 95% cefuroxime axetil). Both treatments were equally well tolerate d. Conclusion: Ciprofloxacin is as effective as cefuroxime axetil in the treat ment of community-acquired acute sinusitis.