The aim of this study was to compare the safety and efficacy of
lomefloxacin, a new difluornated
quinolone, with those of
amoxicillin in the treatment of acute exacerbations of
chronic bronchitis caused by Gram-negative bacteria. The study was conducted as a multicenter, randomized, single-blind comparison in four countries (Argentina, Colombia, Mexico and Venezuela). In total, 163 evaluable patients were assessed-82 in the
lomefloxacin group and 81 in the
amoxicillin group. Patients received oral
therapy with either 40 mg
lomefloxacin once daily or 500 mg
amoxicillin three times daily for 10 days. The most frequent bacterial pathogens isolated included: Haemophilus influenzae, Moraxella catarrhalis, Pseudomonas aeruginosa and Klebsiella pneumoniae. The overall clinical success rates (cure plus improvement) were 93.9% in the
lomefloxacin group and 81.5% in the
amoxicillin group. The eradication rate was 81.7% in the
lomefloxacin group and 75.3% in the
amoxicillin group. Most of the clinical and bacteriological failures in both groups were associated with P. aeruginosa in baseline sputum cultures. In conclusion, once-daily
lomefloxacin is a safe and effective treatment for acute exacerbations of
chronic bronchitis caused by Gram-negative pathogens.