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

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ClinicalTrials.gov Identifier: NCT00258102
Recruitment Status : Completed
First Posted : November 24, 2005
Last Update Posted : June 10, 2011
Sponsor:
Collaborator:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Urinary Tract Infections Bacterial Infections Bacteriuria Urologic Diseases Drug: Levofloxacin Phase 3

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 603 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : January 1993
Study Completion Date : January 1995

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U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00258102


Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
PriCara, Unit of Ortho-McNeil, Inc.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00258102     History of Changes
Other Study ID Numbers: CR005488
First Posted: November 24, 2005    Key Record Dates
Last Update Posted: June 10, 2011
Last Verified: January 2011

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
levofloxacin
urinary tract infections
bacterial infections
bacteriuria
urinary anti-infective agents
urinary infections
quinolones

Additional relevant MeSH terms:
Infection
Communicable Diseases
Urinary Tract Infections
Bacterial Infections
Bacteriuria
Urologic Diseases
Levofloxacin
Ofloxacin
Lomefloxacin
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors