Status:
COMPLETED
A Study of the Safety and Effectiveness of Oral Levofloxacin Compared With Oral Ciprofloxacin 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
Bacteriuria
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 ciprofloxacin in the treatment of complicated urinary tract infections in adu...
Detailed 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 co...
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
- inflammation of the prostate gland
- previous allergic or serious adverse reaction to similar antibiotics
- pregnant or nursing females, or those lacking adequate contraception.
Key Trial Info
Start Date :
June 1 1993
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 1995
Estimated Enrollment :
578 Patients enrolled
Trial Details
Trial ID
NCT00258089
Start Date
June 1 1993
End Date
January 1 1995
Last Update
May 23 2011
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