NCT00258102

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
603

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 1993

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1993

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 1995

Completed
10.9 years until next milestone

First Submitted

Initial submission to the registry

November 22, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 24, 2005

Completed
Last Updated

June 10, 2011

Status Verified

January 1, 2011

First QC Date

November 22, 2005

Last Update Submit

June 8, 2011

Conditions

Urinary Tract InfectionsBacterial InfectionsBacteriuriaUrologic Diseases

Keywords

levofloxacinurinary tract infectionsbacterial infectionsbacteriuriaurinary anti-infective agentsurinary infectionsquinolones

Outcome Measures

Primary Outcomes (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 Outcomes (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.

Interventions

LevofloxacinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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
  • previous allergic or serious adverse reaction to similar antibiotics
  • inflammation of the prostate gland
  • pregnant or nursing females, or those lacking adequate contraception.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Urinary Tract InfectionsBacterial InfectionsBacteriuriaUrologic Diseases

Interventions

Levofloxacin

Condition Hierarchy (Ancestors)

InfectionsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesBacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

OfloxacinFluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic 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
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 22, 2005

First Posted

November 24, 2005

Study Start

January 1, 1993

Study Completion

January 1, 1995

Last Updated

June 10, 2011

Record last verified: 2011-01