Official Title: “A Multicenter, Randomized Study To Compare The Safety And Efficacy Of Oral Levofloxacin With That Of Lomefloxacin HCl In The Treatment Of Complicated Urinary Tract Infections In Adults”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: Levofloxacin

Primary Measures

• Clinical response, the resolution of signs and symptoms at post-therapy compared with those at start of study; Microbiological response, the eradication at post-therapy of infectious organism identified at start of study.

Secondary Measures

• Overall clinical response, described as cured, improved, or failed; incidence of adverse events throughout the study; change in clinical laboratory tests and physical examinations from start of study to post-therapy.

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Overall Clinical Trial Officials and Contacts

Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial Study Director Johnson & Johnson Pharmaceutical Research & Development, L.L.C.  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00258102

Study ID Number: CR005488

ClinicalTrials.gov Identifier: NCT00258102

Health Authority: United States: Food and Drug Administration

A study of the safety and effectiveness levofloxacin compared with lomefloxacin in the treatment of complicated urinary tract infections