Overview

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

Status:
Completed
Trial end date:
1995-01-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborator:
PriCara, Unit of Ortho-McNeil, Inc.
Treatments:
Ciprofloxacin
Levofloxacin
Ofloxacin
Criteria
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.