A Study of the Safety and Effectiveness of Oral Levofloxacin Compared With Oral Ciprofloxacin in the Treatment of Complicated Urinary Tract Infections
A Study of the Safety and Effectiveness of Oral Levofloxacin Compared With Oral Ciprofloxacin 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 ciprofloxacin in the treatment of complicated urinary tract
 infections in adults.
Levofloxacin is an antibacterial agent used for the treatment of a many types of acute
 infections in adults. This is a randomized, double-blind study of the safety and
 effectiveness of levofloxacin compared with ciprofloxacin in the treatment of adults with a
 complicated urinary tract infection. Complicated urinary tract infections include those
 associated with fever, chills, kidney involvement or anatomic and functional abnormalities of
 the bladder. Patients in one group are treated with 250 mg of levofloxacin taken once daily
 for 10 days, and the other group is treated with 500 mg of ciprofloxacin, also an
 antibacterial agent, taken twice daily for 10 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 microbiological response (the eradication at
 post-therapy of the infectious organism identified at the start of the study) and the
 clinical response (the resolution of signs and symptoms at post-therapy compared with those
 at the start of the 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 and as well tolerated as ciprofloxacin in the treatment of adults with
 complicated urinary tract infections. Two levofloxacin 125 mg tablets taken orally once daily
 (and two placebo tablets taken once daily, 12 hours later) for 10 days; or one ciprofloxacin
 500 mg tablet and one placebo tablet taken orally twice daily for 10 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

 -  inflammation of the prostate gland

 -  previous allergic or serious adverse reaction to similar antibiotics

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