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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.

Author(s): Peterson J, Kaul S, Khashab M, Fisher AC, Kahn JB

Affiliation(s): Ortho-McNeil Janssen Scientific Affairs, LLC, Raritan, New Jersey 08869, USA. jpeter13@omjus.jnj.com

Publication date & source: 2008-01, Urology., 71(1):17-22.

Publication type: Comparative Study; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

OBJECTIVES: 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.

Page last updated: 2008-03-26

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