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A Comparison of the Effectiveness and Safety of Levofloxacin to That of Ciprofloxacin in Treating Complicated Urinary Tract Infection and Acute Pyelonephritis
This study has been completed.
Sponsors and Collaborators: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
PriCara, Unit of Ortho-McNeil, Inc.
Information provided by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00210886
  Purpose

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.


Condition Intervention Phase
Pyelonephritis
Urinary Tract Infections
Drug: levofloxacin
Phase III

MedlinePlus related topics: Urinary Tract Infections
Drug Information available for: Levofloxacin Ofloxacin Ofloxacin hydrochloride Ciprofloxacin Ciprofloxacin hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title: A Multicenter, Double-Blind, Randomized Study to Compare the Efficacy and Safety of Levofloxacin 750 mg Once Daily for Five Days Versus Ciprofloxacin Twice Daily for Ten Days in the Treatment of Complicated Urinary Tract Infection and Acute Pyelonephritis.

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • Combination of clinical success and microbiologic eradication (known as therapeutic response) at post-therapy visit.

Secondary Outcome Measures:
  • By patient and pathogen microbiologic and clinical responses at the post-therapy and post-study visits.

Estimated Enrollment: 770
Study Start Date: October 2004
Study Completion Date: April 2006
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 fluoroquinolones have been used successfully to treat urinary and kidney infections. This study will compare the effectiveness and safety of levofloxacin given for 5 days to that of another fluoroquinolone, ciprofloxacin, given for 10 days in treating complicated urinary tract infection or acute pyelonephritis (kidney infection). A shorter course of antibiotics may help patients take all of their medication, which is critically important for curing the infection. A shorter course may also help prevent the development of bacteria that cannot be killed by antibiotics. Patients will take 750 milligrams of levofloxacin intravenously and/or by mouth once daily for 5 days or 400 milligrams of ciprofloxacin intravenously and/or 500 milligrams of ciprofloxacin by mouth twice daily for 10 days. To prevent the study doctor, study staff and patients from knowing which study drug they are taking, all study drug will manufactured to look the same and patients on the 5-day regimen will be given placebo for the last 5 days of their participation in the study. The intravenous infusion bags will be covered so that the solution cannot be seen. The objective of the study is to demonstrate that 5 days of levofloxacin once daily is at least as effective as 10 days of ciprofloxacin twice daily in treating complicated urinary tract infection or acute pyelonephritis.

Patients will take 750 milligrams of levofloxacin intravenously and/or by mouth once daily for 5 days or 400 milligrams of ciprofloxacin intravenously and/or 500 milligrams of ciprofloxacin by mouth twice daily for 10 days.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00210886

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
PriCara, Unit of Ortho-McNeil, Inc.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

Levofloxacin Versus Ciprofloxacin in the Treatment of Complicated Urinary Tract Infection or Acute Pyelonephritis  This link exits the ClinicalTrials.gov site

Publications of Results:
Study ID Numbers: CR004705
Study First Received: September 13, 2005
Last Updated: March 31, 2008
ClinicalTrials.gov Identifier: NCT00210886  
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
urinary tract infection
bladder infection
pyelonephritis
complicated urinary tract infection
kidney infection
acute pyelonephritis

Study placed in the following topic categories:
Ciprofloxacin
Urologic Diseases
Nephritis
Pyelonephritis
Ofloxacin
Urinary Tract Infections
Kidney Diseases

Additional relevant MeSH terms:
Communicable Diseases
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Nephritis, Interstitial
Enzyme Inhibitors
Anti-Infective Agents, Urinary
Infection
Renal Agents
Pyelitis
Pharmacologic Actions
Anti-Bacterial Agents
Therapeutic Uses
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009