A double-blind randomized study comparing ofloxacin and amoxicillin in treating infective episodes in bronchiectasis.

32 hospitalized adult patients with infective episodes of bronchiectasis were enrolled in an ongoing double-blind, placebo-controlled study comparing ofloxacin with amoxicillin. They were randomized to receive either 200 mg ofloxacin or 1 g amoxicillin, both t.i.d. orally for ten days. In the ofloxacin group (15 patients), clinical response was excellent (clinical cure) in 11 and fair (clinical improvement or early reinfection) in three patients with one failure. In the amoxicillin group (17 patients), clinical response was excellent in six, fair in five, and poor (treatment failure) in six patients. Ofloxacin levels at 2 h (day 5) were 2.3 to 8.2 mg/l (mean 3.9 mg/l) for serum and 1.3 to 15 mg/l (mean 4.5 mg/l) for sputum. Sputum: serum ratio was 1.2:1. Amoxicillin levels at 2 h were 10 to 40 mg/l (mean 19.9 mg/l) for serum and 0 to 1.5 mg/l (mean 0.3 mg/l) for sputum, with no amoxicillin detected in sputum in 10 of 17 patients. Sputum: serum ratio was 0.02:1. One patient in the ofloxacin group had nausea. In the amoxicillin group, four patients had nausea and stomach pain, one had vertigo and one had transient peripheral eosinophilia. Ofloxacin thus yielded higher sputum concentration and appeared to be more effective and better tolerated than amoxicillin in infective episodes of bronchiectasis.