Randomized comparison of once-daily ceftibuten and twice-daily clarithromycin in the treatment of acute exacerbation of chronic bronchitis.

In an evaluator-blind, parallel-group, multicenter study, the efficacy and tolerability of ceftibuten 400 mg capsules once daily were compared with clarithromycin 500 mg twice daily for 7-14 days in the treatment of 309 patients with acute exacerbation of chronic bronchitis (AECB). Clinical (n = 262) and microbiological (n = 71) assessments were conducted before treatment, during days 4-6 of treatment, and at 0-6 and 7-21 days after treatment. Clinical efficacy success rates (cure/improvement) at the end of treatment (0-6 days) were 91.0% for ceftibuten and 93.0% for clarithromycin. In the intent-to-treat population, the overall clinical assessment showed a success rate of 77.6% (121/156) in the ceftibuten group and 78.4% (120/153) in the clarithromycin group (95% confidence interval, -10.8 to +9.0%). One patient in each of the ceftibuten and clarithromycin groups had a microbiological relapse and became a treatment failure. The overall success rate was 84.3% for ceftibuten and 86.7% for clarithromycin (C.I. -11.7%, +6.9). Overall eradication of the target pathogens (Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pneumoniae) was 84.8% for ceftibuten and 89.5% for clarithromycin. Eradication rates for ceftibuten at 0-6 days post treatment were 95.2% (H. influenzae), 87.5% (M. catarrhalis), and 100% (S. pneumoniae), compared with 85.7%, 100% and 100%, respectively, for clarithromycin. Significantly fewer patients in the ceftibuten group experienced treatment-related adverse events than in the clarithromycin group (5.3 vs 21.9%; p < 0.001). This difference was due to a large number of patients in the clarithromycin group reporting taste perversion (12.6%) or gastrointestinal adverse events (9.9%). Given its tolerability and efficacy profiles, and the advantage of once-daily administration, ceftibuten provides a rational alternative for the treatment of AECB.