The safety and efficacy of short course (5-day) moxifloxacin vs. azithromycin in the treatment of patients with acute exacerbation of chronic bronchitis
Abstract
Chronic bronchitis is common among adults and infectious exacerbations contribute considerably to morbidity and mortality. We aimed to compare the safety and efficacy of moxifloxacin to azithromycin for the treatment of patients with acute exacerbations of chronic bronchitis (AECB) of suspected bacterial origin. Between October 1998 and April 1999, 567 patients with AECB were enrolled at 37 centers across the United States and Canada of which 280 (49%) had acute bacterial exacerbation of chronic bronchitis (i.e. pretherapy pathogen). Patients were randomized to either oral moxifloxacin 400 mg administered once daily for 5 days or azithromycin for 5 days (500 mg qd x 1, then 250 mg qd x 4). For the purpose of study blinding, all patients received encapsulated tablets. The main outcome measure was clinical response at the test-of-cure visit (14-21 days post-therapy). Secondary measures included bacteriologic response and a time-course of bacteriological eradication (one center only). Three patient populations were analysed for efficacy: clinically-valid, microbiologically-valid (i.e. those with a pretherapy pathogen), and intent-to-treat (i.e. received at least one dose of study drug). For the efficacy-valid group, clinical response at the test-of-cure visit was 88% for patients in each treatment group. In 237 microbiologically-valid patients, corresponding clinical resolution rates were 88% for 5-day moxifloxacin vs. 86% for 5-day azithromycin. Bacteriological eradication…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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