Short-course moxifloxacin therapy for treatment of acute bacterial exacerbations of chronic bronchitis

Chronic bronchitis is common among adults and infectious exacerbations cont ribute considerably to morbidity and mortality. We aimed to compare the saf ety and efficacy of moxifloxacin to clarithromycin for the treatment of pat ients with acute bacterial exacerbations of chronic bronchitis (ABECB) usin g a prospective, randomized, double-blind, parallel group trial. Between November 21, 1996 and April 7, 1998, 936 patients with acute exacer bations of chronic bronchitis (AECB) were enrolled at 56 centers across the United States of which 491 (52%) had ABECB (i.e. pretherapy pathogen). Patients were randomized to either oral moxifloxacin 400 mg administer once daily, for either 5 or 10 days, or clarithromycin 500 mg bid for 10 days. For the purpose of study blinding, the patients taking moxifloxacin receive d placebo to maintain uniform dosing. The main outcome measures were bacteriological response at the end of thera py (post-therapy days 0-6) and follow-up (7-17 days post-therapy) visits, a s well as overall clinical response, clinical response at the end of therap y and clinical response at follow-up. Two patient populations were analyzed : emcocy-valid (i.e., those with a pretherapy pathogen) and intent-to-treat (i.e., all subjects that took drug). In 420 efficacy valid patients with a pretherapy organism, overall clinical resolution was 89% for 5 days moxifloxacin vs. 91% for 10 day moxifloxacin vs. 91% for 10 day clarithromycin. Bacteriological eradication rates at th e end of therapy were 94% and 95% for 5-day moxifloxacin and 10-day moxiflo xacin, respectively, and 91% for the clarithromycin group. Eradication rate s at follow-up were 89% and 91% for 5-day moxifloxacin and 10-day monifloxa cin respectively, and 85% for the clarithromycin group. Among 926 intent-to -treat patients (312 5-day moxifloxacin. 302 10-day moxifloxacin and 312 cl arithromycin), drug-related events were reported for 26%, 30% and 35%, resp ectively. Moxifloxacin 400 mg once daily, as a 5 or 10 day regiment was found to be c linically and bacteriologically equivalent to 10 day clarithromycin for the treatment of ABECB. Given its favorable safety and tolerability profile. m oxifloxacin administered once daily for 5 days may be as effective and a mo re convenient treatment than a standard course of clarithromycin for patien ts with ABECB.