A Study of the Safety and Effectiveness of Levofloxacin Compared With Lomefloxacin in the Treatment of Complicated Urinary Tract Infections

NCT ID: NCT00258102

Last Updated: 2011-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 603 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1993-01-31
• Study Completion Date: 1995-01-31

Brief Summary

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.

Detailed Description

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.

Conditions

Urinary Tract Infections; Bacterial Infections; Bacteriuria; Urologic Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Levofloxacin

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PriCara, Unit of Ortho-McNeil, Inc.

INDUSTRY

Sponsor Role: collaborator

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

Sponsor Role: lead

Principal Investigators

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=655&filename=CR005488_CSR.pdf

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

Other Identifiers

CR005488

Identifier Type: -

Identifier Source: org_study_id