T. File et al., Gemifloxacin versus amoxicillin/clavulanate in the treatment of acute exacerbations of chronic bronchitis, J CHEMOTHER, 12(4), 2000, pp. 314-325
Six hundred patients were evaluated in this randomized, double-blind, doubl
e-dummy, multicenter, parallel-group study comparing the efficacy and safet
y of gemifloxacin (320 mg once-daily for 5 days) and amoxicillin/clavulanat
e (500/125 mg three-times daily for 7 days) for the treatment of acute exac
erbations of chronic bronchitis (AECB). Of note, more than 90% of study par
ticipants had stage 2 disease at study entry, The two drugs were found to b
e 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 amoxicill
in/clavulanate; 95% CI -3.3 to 26.0); however, this difference was not stat
istically significant. Gemifloxacin and amoxicillin/clavulanate were both w
ell tolerated. In summary, gemifloxacin was found to be well tolerated and
effective for the treatment of AECB, suggesting it is well suited for empir
ical treatment of this common respiratory condition in the current clinical
environment.