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Sponsors and Collaborators: |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. PriCara, Unit of Ortho-McNeil, Inc. |
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Information provided by: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
ClinicalTrials.gov Identifier: | NCT00258089 |
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 |
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Pyelonephritis Neurogenic Bladder Bacteriuria Urologic Diseases Urinary Tract Infections |
Drug: Levofloxacin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 500 |
Study Start Date: | June 1993 |
Estimated Study Completion Date: | January 1995 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Study ID Numbers: | CR005482 |
Study First Received: | November 22, 2005 |
Last Updated: | May 11, 2007 |
ClinicalTrials.gov Identifier: | NCT00258089 |
Health Authority: | United States: Food and Drug Administration |
bacterial infections quinolones urinary anti-infective agents urinary tract infections |
urinary infections levofloxacin bacteriuria |
Bacterial Infections Urinary Bladder, Neurogenic Cystocele Pyelonephritis Urinary Tract Infections Urinary Bladder Diseases Ofloxacin |
Ciprofloxacin Signs and Symptoms Urologic Diseases Nephritis Neurologic Manifestations Kidney Diseases Bacteriuria |
Communicable Diseases Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Nephritis, Interstitial Nervous System Diseases Enzyme Inhibitors Anti-Infective Agents, Urinary |
Renal Agents Infection Pyelitis Pharmacologic Actions Anti-Bacterial Agents Therapeutic Uses Nucleic Acid Synthesis Inhibitors |