Status:
COMPLETED
A Comparison of the Effectiveness and Safety of Levofloxacin to That of Ciprofloxacin in Treating Complicated Urinary Tract Infection and Acute Pyelonephritis.
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
PriCara, Unit of Ortho-McNeil, Inc.
Conditions:
Urinary Tract Infections
Pyelonephritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 cou...
Detailed Description
Levofloxacin has been approved in both its oral and intravenous forms to treat a large number of infections caused by bacteria. Levofloxacin and other members of a class of antibiotics known as fluoro...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2006
Estimated Enrollment :
1109 Patients enrolled
Trial Details
Trial ID
NCT00210886
Start Date
October 1 2004
End Date
April 1 2006
Last Update
June 10 2011
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