A double-blind, randomized comparison of levofloxacin 750 mg once-daily for five days with ciprofloxacin 400/500 mg twice-daily for 10 days for the treatment of complicated urinary tract infections and acute pyelonephritis.
OBJECTIVE
A clinical study was conducted to compare the efficacy and safety of levofloxacin 750 mg once daily for 5 days to ciprofloxacin twice daily for 10 days for the treatment of complicated urinary tract infections (cUTI) or acute pyelonephritis (AP).


METHODS
A multicenter, double-blind, randomized, noninferiority study enrolled subjects with AP or cUTI. Subjects received either levofloxacin 750 mg intravenously or orally once daily for 5 days or ciprofloxacin 400 mg intravenously and/or ciprofloxacin 500 mg orally twice daily for 10 days and were evaluated at end of therapy, posttherapy, and poststudy for microbiologic eradication and clinical outcome.


RESULTS
A total of 1109 subjects were enrolled; 619 with confirmed diagnosis of AP or cUTI and a study entry uropathogen with a colony count 10(5) CFU/mL or greater and were included in the modified intent-to-treat population. Five hundred six subjects met all criteria for inclusion and were included in the microbiologically evaluable population. At end of therapy, eradication rates in the modified intent-to-treat population were 79.8% for levofloxacin and 77.5% for ciprofloxacin-treated subjects (95% CI, -8.8% to 4.1%). In the microbiologically evaluable population, eradication rates were 88.3% for levofloxacin and 86.7% for ciprofloxacin-treated subjects (95% CI, -7.4% to 4.2%). Outcomes were comparable for the 2 treatments at posttherapy and poststudy.


CONCLUSIONS
This study demonstrates that both drug regimens are safe and effective and that a 5-day course of therapy with levofloxacin, administered at a dose of 750 mg once daily, is noninferior to a 10-day course of therapy with ciprofloxacin for the treatment of AP and cUTI.
Peterson
Janet
J
Ortho-McNeil Janssen Scientific Affairs, LLC, Raritan, New Jersey 08869, USA. jpeter13@omjus.jnj.com
Kaul
Simrati
S
Khashab
Mohammed
M
Fisher
Alan C
AC
Kahn
James B
JB
D000208:Acute Disease; D000328:Adult; D000368:Aged; D000890:Anti-Infective Agents / Q000008:administration & dosage*; D000892:Anti-Infective Agents, Urinary / Q000008:administration & dosage*; D002939:Ciprofloxacin / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D064704:Levofloxacin; D008297:Male; D008875:Middle Aged; D015242:Ofloxacin / Q000008:administration & dosage*; D011704:Pyelonephritis / Q000188:drug therapy*; D016896:Treatment Outcome; D014546:Urinary Catheterization; D014552:Urinary Tract Infections / Q000188:drug therapy*
D000890:Anti-Infective Agents; D000892:Anti-Infective Agents, Urinary; D002939:Ciprofloxacin; D064704:Levofloxacin; D015242:Ofloxacin