Status:

COMPLETED

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

Lead Sponsor:

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

Collaborating Sponsors:

PriCara, Unit of Ortho-McNeil, Inc.

Conditions:

Urinary Tract Infections

Bacterial Infections

Eligibility:

All Genders

18+ years

Phase:

PHASE3

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 adul...

Detailed Description

Levofloxacin is an antibacterial agent used for the treatment of a broad spectrum of acute infections in adults. This is a randomized, open-label study of the safety and effectiveness of levofloxacin ...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

January 1 1993

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 1995

Estimated Enrollment :

603 Patients enrolled

Trial Details

Trial ID

NCT00258102

Start Date

January 1 1993

End Date

January 1 1995

Last Update

June 10 2011

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