Objectives, To evaluate, in two randomized, multicenter trials, levofl
oxacin compared with ciprofloxacin and lomefloxacin for efficacy and s
afety in treating acute pyelonephritis. Methods, We enrolled a total o
f 186 patients with bacteriologically proved infection. Of these, 89 p
atients in both trials combined received levofloxacin 250 mg once dail
y; 58 received ciprofloxacin 500 mg twice daily in the first trial (do
uble blind); and 39 received lomefloxacin 400 mg once daily in the sec
ond trial (open label). Microbiologic response of patients evaluable f
or microbiologic efficacy was the primary efficacy variable, and clini
cal response of microbiologically evaluable patients was the secondary
efficacy variable in both studies. Results, Escherichia coli was the
most prevalent pathogen. At 5 to 9 days after the end of treatment, 95
% of uropathogens were eradicated in patients who received levofloxaci
n compared with 94% in the ciprofloxacin-treated group and 95% in the
lomefloxacin-treated group. The clinical cure rate was 92% for levoflo
xacin in both studies combined, 88% for ciprofloxacin, and 80% for lom
efloxacin, Drug-related adverse events were reported by 2% of levoflox
acin-treated patients, 8% of ciprofloxacin-treated patients, and 5% of
lomefloxacin-treated patients. Conclusions. The once-daily oral admin
istration, proven efficacy, and good tolerability make levofloxacin an
excellent choice for empiric treatment of acute pyelonephritis, (C) 1
998, Elsevier Science Inc. All rights reserved.