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.