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

This study has been completed.
Sponsor:
Collaborator:
PriCara, Unit of Ortho-McNeil, Inc.
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00258089
First received: November 22, 2005
Last updated: May 19, 2011
Last verified: November 2010
  Purpose

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.


Condition Intervention Phase
Urinary Tract Infections
Bacteriuria
Urologic Diseases
Pyelonephritis
Neurogenic Bladder
Drug: Levofloxacin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Randomized Study To Compare The Safety And Efficacy Of Oral Levofloxacin With That Of Ciprofloxacin HCl In The Treatment Of Complicated Urinary Tract Infections In Adults

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

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

Secondary Outcome Measures:
  • Overall clinical response (described as cured, improved or failed) at long-term follow up; incidence of adverse events throughout the study; change in clinical laboratory tests and physical examinations from start of study to post-therapy.

Enrollment: 578
Study Start Date: June 1993
Study Completion Date: January 1995
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  • inflammation of the prostate gland
  • previous allergic or serious adverse reaction to similar antibiotics
  • pregnant or nursing females, or those lacking adequate contraception.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00258089

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:
No publications provided

ClinicalTrials.gov Identifier: NCT00258089     History of Changes
Other Study ID Numbers: CR005482
Study First Received: November 22, 2005
Last Updated: May 19, 2011
Health Authority: United States: Food and Drug Administration

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:
Bacteriuria
Urinary Bladder, Neurogenic
Pyelonephritis
Urinary Tract Infections
Urologic Diseases
Infection
Neurologic Manifestations
Nervous System Diseases
Urinary Bladder Diseases
Signs and Symptoms
Nephritis, Interstitial
Nephritis
Kidney Diseases
Pyelitis
Anti-Infective Agents
Ciprofloxacin
Ofloxacin
Anti-Infective Agents, Urinary
Therapeutic Uses
Pharmacologic Actions
Renal Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on July 20, 2014