In a multicenter study the efficacy and safety of oral
fleroxacin at 400 mg once a day and
amoxicillin at 500 mg three times daily for 7 days were compared for the treatment of patients with acute bacterial exacerbations of
chronic bronchitis due to
drug-susceptible bacteria. A total of 194 patients were enrolled, 102 in the
fleroxacin group and 92 in the
amoxicillin group. Of those enrolled, 22 in the
fleroxacin group and 30 (29 for clinical efficacy) in the
amoxicillin group were included in the efficacy analysis. All were included in the safety analysis. Clinical success was noted in 21 (95%) of 22
fleroxacin-treated patients and 22 (76%) of 29
amoxicillin-treated patients. Bacteriologic cure was obtained in 21 (95%) of 22 of the
fleroxacin group and 18 (60%) of 30 of the
amoxicillin group. One Haemophilus parainfluenzae strain persisted with
fleroxacin. Persisting organisms with
amoxicillin included Haemophilus influenzae (four), Haemophilus parainfluenzae (three), Escherichia coli (two), Streptococcus pneumoniae (one), Neisseria species (one), and Proteus mirabilis (one). Adverse events were reported by 41% of 102 patients receiving
fleroxacin and 15% of 92 patients receiving
amoxicillin.
Insomnia,
dizziness, and
nausea occurred more frequently with
fleroxacin.
Fleroxacin may be indicated for the treatment of acute
bacterial infection in
chronic bronchitis known to be due to Haemophilus species and Moraxella catarrhalis. The 92% incidence of resistance among the S. pneumoniae isolates recovered from all enrolled patients suggests that
fleroxacin may not be useful for such
infections.