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

NCT00258089 | Completed Phase 3

• 1 other identifier: CR005482
• Study Type: interventional
• Target: 578
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Urinary Tract Infections; Bacteriuria; Urologic Diseases; Pyelonephritis; Neurogenic Bladder

Keywords

levofloxacin; urinary tract infections; bacterial infections; bacteriuria; urinary anti-infective agents; urinary infections; quinolones

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Interventions

Levofloxacin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead
• PriCara, Unit of Ortho-McNeil, Inc.: collaborator

Related Links

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

MeSH Terms

Conditions

Urinary Tract Infections; Bacteriuria; Urologic Diseases; Pyelonephritis; Urinary Bladder, Neurogenic; Bacterial Infections

Interventions

Levofloxacin

Condition Hierarchy (Ancestors)

Infections; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Nephritis, Interstitial; Nephritis; Kidney Diseases; Pyelitis; Neurologic Manifestations; Nervous System Diseases; Urinary Bladder Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

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

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 22, 2005
• First Posted: November 24, 2005
• Study Start: June 1, 1993
• Study Completion: January 1, 1995
• Last Updated: May 23, 2011

Record last verified: 2010-11