Safety and Efficacy Study of the Treatment of Kidney Infections With Short Course Levofloxacin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00239161
Recruitment Status : Terminated
First Posted : October 14, 2005
Last Update Posted : October 14, 2005
Ortho-McNeil Pharmaceutical
Janssen-Ortho Inc., Canada
PriCara, Unit of Ortho-McNeil, Inc.
Information provided by:
University of Manitoba

Brief Summary:
The purpose of the study is to compare the safety and effectiveness of the antibiotic levofloxacin by administering a higher dose of levofloxacin using a shorter course of therapy to treat patients with infections of their kidney.

Condition or disease Intervention/treatment Phase
Acute Uncomplicated Pyelonephritis Drug: Levofloxacin Phase 4

Detailed Description:

The goal is to complete a pilot study of short course (5 days), high dose, levofloxacin treatment for women with acute uncomplicated pyelonephritis. Specific study objectives include:

  1. To assess the efficacy and tolerability of levofloxacin 750 mg once daily for treatment of acute uncomplicated pyelonephritis in 25 women.
  2. To describe the population pharmacokinetics of levofloxacin 750 mg once daily in treatment of young women with acute pyelonephritis.
  3. To identify urine proteins associated with the inflammatory response of acute pyelonephritis, and characterize the time course of resolution of these proteins following initiation of treatment.

Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : September 2004
Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Microbiological cure at the 10-14 day and 33-35 day followup

Secondary Outcome Measures :
  1. Clinical outcome at each visit. Microbiologic outcomes at 24,48,and72 hrs, adverse antimicrobial effects, adverse events or antimicrobial resistance. Correlation between pharmacodynamic parameters, bacteriologic and clinical resolution will be analyzed.

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion criteria:

  • Recent onset (less than 7 days) of costovertebral angle pain or tenderness with or without fever, and with or without lower urinary tract symptoms (dysuria, frequency, urgency). Diabetic women without long term complications of diabetes (retinopathy, nephropathy, or neuropathy) may be enrolled.
  • Stable hemodynamic status and able to tolerate oral medication.
  • Pretherapy urine culture >107 cfu/L (>104 cfu/ml) of a uropathogen (E. coli, other Enterobacteriaceae, S. saprophyticus). Patients will be enrolled into the study prior to urine culture results being known. If pretherapy cultures are subsequently not positive (usually at 48 hours), subjects will be discontinued.
  • Pyuria (> 10 wbc/mm3 or > 10 X106 wbc/L by hemocytometer; > 6-10 wbc/hpf, or > 1+ LE (leukocyte esterase) dipstick).

Exclusion Criteria:

·Pregnancy, breastfeeding, fluoroquinolone allergy, and any underlying structural or functional genitourinary abnormality.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00239161

Canada, Manitoba
St. Boniface General Hospital
Winnipeg, Manitoba, Canada, R2H 2A6
Health Sciences Centre
Winnipeg, Manitoba, Canada, R3A 1R9
Misericordia Urgent Care
Winnipeg, Manitoba, Canada, R3C 1A2
University of Manitoba
Winnipeg, Manitoba, Canada, R3E 0W3
Sponsors and Collaborators
University of Manitoba
Ortho-McNeil Pharmaceutical
Janssen-Ortho Inc., Canada
PriCara, Unit of Ortho-McNeil, Inc.
Principal Investigator: Lindsay E Nicolle, MD, FRCPC University of Manitoba
Principal Investigator: Godfrey KM Harding, MD, FRCPC University of Manitoba
Principal Investigator: George G Zhanel, PhD, FCCP University of Manitoba Identifier: NCT00239161     History of Changes
Other Study ID Numbers: CAPSS-353
First Posted: October 14, 2005    Key Record Dates
Last Update Posted: October 14, 2005
Last Verified: August 2005

Keywords provided by University of Manitoba:

Additional relevant MeSH terms:
Nephritis, Interstitial
Kidney Diseases
Urologic Diseases
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors