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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.

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ClinicalTrials.gov Identifier: NCT00210886
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : June 10, 2011
Sponsor:
Collaborator:
PriCara, Unit of Ortho-McNeil, Inc.
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 21, 2005
Last Update Posted Date June 10, 2011
Study Start Date  ICMJE October 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
Combination of clinical success and microbiologic eradication (known as therapeutic response) at post-therapy visit.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00210886 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
By patient and pathogen microbiologic and clinical responses at the post-therapy and post-study visits.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Comparison of the Effectiveness and Safety of Levofloxacin to That of Ciprofloxacin in Treating Complicated Urinary Tract Infection and Acute Pyelonephritis.
Official Title  ICMJE 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.
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 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Urinary Tract Infections
  • Pyelonephritis
Intervention  ICMJE Drug: levofloxacin
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 25, 2009)
1109
Original Enrollment  ICMJE
 (submitted: September 13, 2005)
770
Actual Study Completion Date  ICMJE April 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00210886
Other Study ID Numbers  ICMJE CR004705
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators  ICMJE PriCara, Unit of Ortho-McNeil, Inc.
Investigators  ICMJE
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
PRS Account Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Verification Date April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP