A Comparison of the Effectiveness and Safety of Levofloxacin to That of Ciprofloxacin in Treating Complicated Urinary Tract Infection and Acute Pyelonephritis.

• Status: Completed
• Trial end date: 2006-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effectiveness and safety of two antibiotics in the treatment of complicated urinary tract infection or acute pyelonephritis (kidney infection). A 5-day course of 750 milligrams of levofloxacin given intravenously and/or by mouth once daily will be compared to a 10-day course of 400 milligrams of ciprofloxacin given intravenously and/or 500 milligrams of ciprofloxacin given by mouth twice daily.

• 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:

• Positive dipstick test for leukocyte esterase AND/OR at least 5 white blood cells per centrifuged urine sediment AND/OR at least 10 white blood cells per microliter of uncentrifuged urine

• outpatient or inpatient (in hospital, nursing home, or other extended-care facility)

• clinical diagnosis of either complicated urinary tract infection or acute pyelonephritis.

Exclusion Criteria:

• Allergy or serious adverse reaction to levofloxacin, ciprofloxacin, or other fluoroquinolone

• urinary tract surgery or lithotripsy (treatment for kidney stones) within 7 days before study entry

• a second coexisting bacterial infection that requires systemic antibiotics

• need for a second antibiotic to treat the urinary tract infection

• obstruction of the urinary tract

• prostate infection.