A Study of the Safety and Effectiveness of Levofloxacin Compared With Lomefloxacin in the Treatment of Complicated Urinary Tract Infections
A Study of the Safety and Effectiveness of Levofloxacin Compared With Lomefloxacin in the Treatment of Complicated Urinary Tract Infections
The purpose of the study is to compare the safety and effectiveness of oral levofloxacin (an
 antibiotic) with that of oral lomefloxacin in the treatment of complicated urinary tract
 infections in adults.
Levofloxacin is an antibacterial agent used for the treatment of a broad spectrum of acute
 infections in adults. This is a randomized, open-label study of the safety and effectiveness
 of levofloxacin compared with lomefloxacin in the treatment of adults with complicated
 urinary tract infections. Patients in one group are treated with 250 mg of levofloxacin,
 taken once daily for 7 to 10 days, and the other group is treated with 400 mg of
 lomefloxacin, also an antibacterial agent, taken once daily for 14 days. Patients are
 followed for 5 to 9 days after completion of treatment (post-therapy) to assess clinical
 signs and symptoms of infection. Long-term follow up (4 to 6 weeks after the end of
 treatment) of those patients who respond to therapy provides further evaluation of clinical
 signs and symptoms. The primary assessments of effectiveness include the clinical response
 (the resolution of signs and symptoms at post-therapy compared with those at the start of
 study) and the microbiological response (the eradication at post-therapy of the infectious
 organism identified at the start of study) An additional assessment of efficacy includes the
 overall clinical response, which is described as cured, improved, or failed. Safety
 assessments include the incidence of adverse events throughout the study, clinical laboratory
 tests (hematology, serum chemistry, and urinalysis) and physical examinations at the start of
 the study and post-therapy. The study hypothesis is that levofloxacin is at least as
 effective therapeutically as lomefloxacin in the treatment of adults with complicated urinary
 tract infections. Levofloxacin tablets, an oral dose of 250 mg taken once daily for 7 to 10
 days. Lomefloxacin tablets, an oral dose of 400 mg taken once daily for 14 days.
Inclusion Criteria:

 -  Diagnosis of a urinary tract infection with complicating factors such as anatomical or
 functional abnormalities

 -  capable of taking medication by mouth

 -  previous antibacterial therapy of less than 24 hours, or previous antibacterial
 therapy of greater than 24 hours that did not eliminate or stabilize the infection.

 Exclusion Criteria:

 -  Patients having any medical condition that requires antimicrobial therapy to be given
 intravenously or by hypodermic needle

 -  complete obstruction of any part of the urinary tract

 -  previous allergic or serious adverse reaction to similar antibiotics

 -  inflammation of the prostate gland

 -  pregnant or nursing females, or those lacking adequate contraception.