Double-blind comparative trial of ciprofloxacin versus clarithromycin in the treatment of acute bacterial sinusitis. Sinusitis Infection Study Group

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) in 560 adults with clinically documented and radiologically confirmed acute sinusitis. Of 457 efficacy‐valid adults (236 CIP, 221 CLARI), clinical resolution plus improvement at the end of therapy was 84% for CIP‐treated patients compared to 91% of CLARI recipients (CI95 = ‐0.131, ‐0.013). At the 1‐month follow‐up, more than twice as many CLARI‐treated patients, 18 (10%), experienced a relapse, compared to 7 (4%) CIP‐treated patients. The combined clinical response analyses (end of therapy and 1 ‐month follow‐up) demonstrated that CIP and CLARI were statistically equivalent (CI95 = ‐0.106, 0.044). Diarrhea, nausea, headache, and dizziness were the most frequently reported drug‐related adverse events in both treatment groups; diarrhea and taste perversion were reported more frequently among CLARI recipients. In summary, the combined end of therapy and follow‐up clinical evaluation analyses revealed that CIP and CLARI were equally effective in the management of acute sinusitis, although twice as many relapses were reported among CLARI recipients.