Ciprofloxacin versus cefuroxime axetil in the treatment of acute bacterial sinusitis. Sinusitis Infection Study Group.
ENT Consultants of Winchester, Virginia 22601, USA.
OBJECTIVE: This study was conducted to compare the efficacy and safety of ciprofloxacin to cefuroxime axetil for the management of acute bacterial sinusitis 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 symptoms and radiographic evidence of acute maxillary sinusitis randomly received 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 microbiologic etiology. The primary measure of efficacy was the rate of clinical success in the efficacy-valid population at the end of therapy. Secondary measures included bacteriologic response at the end of therapy, and 2- to 4-week clinical and bacteriologic follow-up response rates in both efficacy-valid and intent-to-treat groups. RESULTS: Haemophilus influenzae (21%), Streptococcus pneumoniae (19%), Moraxella catarrhalis (14%), and Staphylococcus aureus (9%) were the most commonly isolated pathogens (target organisms) among the 225 causative organisms identified from 189 patients. Of 453 adults valid for clinical efficacy (228 ciprofloxacin, 225 cefuroxime axetil), ciprofloxacin treatment was statistically equivalent to cefuroxime axetil at the end of treatment (87% vs. 83%; 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 positive cultures, including the subset with target organisms. Bacteriologic eradication at end of therapy was similar between the two groups (97% ciprofloxacin, 95% cefuroxime axetil). Both treatments were equally well tolerated. CONCLUSION: Ciprofloxacin is as effective as cefuroxime axetil in the treatment of community-acquired acute sinusitis.
PMID: 10077777 [PubMed - indexed for MEDLINE]