This study enrolled patients with complicated
urinary tract infections (UTIs) in a trial to determine the efficacy and safety of sequential
therapy with intravenous
fleroxacin (first 3 days) followed by oral
fleroxacin, for a total course of 7-14 days, both administered at a dosage of 400 mg once a day. We enrolled 68 patients with complicated UTIs or acute
pyelonephritis, 32 of whom were evaluable for bacteriologic and clinical efficacy. The pathogens isolated included Escherichia coli, 15; enterococci, 9; miscellaneous, 15. Intravenous
fleroxacin was given for a mean of 3.2 days, followed by oral
fleroxacin for a mean of 5.3 days. A total of 27 patients were clinically cured (84%), two improved, and three failed. A total of 26 patients were bacteriologically cured (81%), and six failed (19%). The bacteria that were not eradicated included enterococci, 4; Staphylococcus epidermidis, 1; and Pseudomonas species, 1. One enterococcal isolate became resistant to
fleroxacin. Four patients were bacteremic (E. coli, 3; Proteus mirabilis, 1); the pathogen was eradicated in all cases. Two patients developed urinary enterococcal
superinfections. A total of 12 patients experienced 16 adverse reactions remotely, possibly, or probably related to
fleroxacin (
insomnia, 3;
dizziness, 2; miscellaneous, 11). One patient had a grand mal seizure after aspirating gastric contents; the seizure was thought to be only remotely related to the study
drug.
Fleroxacin was discontinued in two patients because of adverse effects (
phlebitis at intravenous access site, 1; anxiety and
insomnia, 1). Only minor and asymptomatic laboratory abnormalities were observed. All clinical and laboratory abnormalities resolved with discontinuation of the study
drug.
Fleroxacin is a safe and effective
antibiotic for sequential intravenous and oral treatment of acute
pyelonephritis and complicated UTIs. Enterococci may be problematic pathogens, as reported with other
fluoroquinolones.