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

Urinary Tract Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00258089
• Other study ID #: CR005482
• Status: Completed
• Phase: Phase 3
• First received: November 22, 2005
• Last updated: May 19, 2011
• Start date: June 1993
• Est. completion date: January 1995

Study information

• Verified date: November 2010
• Source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 578
• Est. completion date: January 1995
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bacteriuria
• Communicable Diseases
• Infection
• Neurogenic Bladder
• Pyelonephritis
• Urinary Bladder, Neurogenic
• Urinary Tract Infections
• Urologic Diseases

Intervention

Drug:
• Levofloxacin

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	PriCara, Unit of Ortho-McNeil, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.

External Links

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