Double-blind comparative trial of ciprofloxacin versus clarithromycin in the treatment of acute bacterial sinusitis

This multicenter, randomized, double-blind trial compared the efficacy and safety of ciprofloxacin (CIP; 500 mg twice daily for 10 days, placebo for 4 days) to those of clarithromycin (CLARI; 500 mg twice daily for 14 days) i n 560 adults with clinically documented and radiologically confirmed acute sinusitis. Of 457 efficacy-valid adults (236 CIP, 221 CLARI), clinical reso lution plus improvement at the end of therapy was 84% for CIP-treated patie nts compared to 91% of CLARI recipients (CI95 =-0.131, -0.013). At the 1-mo nth follow-up, more than twice as many CLARI-treated patients, 18 (10%), ex perienced a relapse, compared to 7 (4%) CLP treated patients. The combined clinical response analyses (end of therapy and I-month follow-up) demonstra ted that CIP and CLARI were statistically equivalent (CI95 = -0.106, 0.044) . Diarrhea, nausea, headache, and dizziness were the most frequently report ed drug-related adverse events in both treatment groups; diarrhea and taste perversion were reported more frequently among CLARI recipients. Zn summar y, the combined end of therapy and follow-up clinical evaluation analyses r evealed that CIP and CLARI were equally effective in the management of acut e sinusitis, although twice as many relapses were reported among CLARI reci pients.