Gemifloxacin versus amoxicillin/clavulanate in the treatment of acute exacerbations of chronic bronchitis. The 070 Clinical Study group.

Gemifloxacin versus amoxicillin/clavulanate in the treatment of acute exacerbations of chronic bronchitis. The 070 Clinical Study group.

File T; Schlemmer B; Garau J; Lode H; Lynch S; Young C

Journal of chemotherapy (Florence, Italy)

2000

2000-08

Six hundred patients were evaluated in this randomized, double-blind, double-dummy, multicenter, parallel-group study comparing the efficacy and safety of gemifloxacin (320 mg once-daily for 5 days) and amoxicillin/clavulanate (500/125 mg three-times daily for 7 days) for the treatment of acute exacerbations of chronic bronchitis (AECB). Of note, more than 90% of study participants had stage 2 disease at study entry. The two drugs were found to be equally effective, with clinical success rates of 93.6% for gemifloxacin and 93.2% on amoxicillin/clavulanate (95% CI -3.9 to 4.6). Bacteriological success rates favored gemifloxacin (90.9% compared with 79.5% for amoxicillin/clavulanate; 95% CI -3.3 to 26.0); however, this difference was not statistically significant. Gemifloxacin and amoxicillin/clavulanate were both well tolerated. In summary, gemifloxacin was found to be well tolerated and effective for the treatment of AECB, suggesting it is well suited for empirical treatment of this common respiratory condition in the current clinical environment.

*Fluoroquinolones; 80 and over; Acute-Phase Reaction; Adult; Aged; Amoxicillin/pharmacology/therapeutic use; Anti-Infective Agents/adverse effects/pharmacology/*therapeutic use; Bronchitis/*drug therapy; Chronic Disease; Clavulanic Acid/pharmacology/therapeutic use; Combination/pharmacology/*therapeutic use; Double-Blind Method; Drug Therapy; Female; Gemifloxacin; Haemophilus influenzae/drug effects; Humans; Male; Microbial Sensitivity Tests; Middle Aged; Moraxella (Branhamella) catarrhalis/drug effects; Multicenter Studies as Topic; Naphthyridines/adverse effects/pharmacology/*therapeutic use; Streptococcus pneumoniae/drug effects; Treatment Outcome

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