Multicenter, randomized study comparing efficacy and safety of oral levofloxacin and cefaclor in treatment of acute bacterial exacerbations of chronic bronchitis

This prospective, multicenter randomized trial compared the safety and efficacy of 5-7 of therapy with oral levofloxacin (500 mg qd) with 7-10 days of therapy with cefaclor (250 mg tid) in the treatment of patients with acute bacterial exacerbations of chronic bronchitis (ABECB). One hundred ninety- two patients were evaluable of microbiologic efficacy. The overall bacteriologic eradication rates by pathogen were 94% and 87% for levoflaxacin and cefaclor, respectively. Levofloxacin eradicated 100% of Haemophilus influenzae, 95% of Moraxella catarrhalis, and 90% of Streptococcus pneumoniae organisms vs. 71%, 100%, and 86%, respectively, for cefaclor. Clinical success was observed in 92% of the patients in both groups. Drug-related adverse events were reported in 7% and 5% of patients, respectively, with gastrointestinal adverse events being the most common. These results indicate that once a day dosing of levofloxacin (500 mgg) is as effective and well tolerated as three-times-per-day dosing of cefaclor (250 mgg) in the treatment of patients with ABECB.