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

Primary Purpose

Acute Uncomplicated Pyelonephritis

Status
Terminated
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Levofloxacin
Sponsored by
University of Manitoba
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Uncomplicated Pyelonephritis focused on measuring Pyelonephritis

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • St. Boniface General Hospital
  • Health Sciences Centre
  • Misericordia Urgent Care
  • University of Manitoba

Outcomes

Primary Outcome Measures

Microbiological cure at the 10-14 day and 33-35 day followup

Secondary Outcome Measures

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.

Full Information

First Posted
October 12, 2005
Last Updated
October 12, 2005
Sponsor
University of Manitoba
Collaborators
Ortho-McNeil Pharmaceutical, Janssen-Ortho Inc., Canada, PriCara, Unit of Ortho-McNeil, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00239161
Brief Title
Safety and Efficacy Study of the Treatment of Kidney Infections With Short Course Levofloxacin
Official Title
TREATMENT OF ACUTE UNCOMPLICATED PYELONEPHRITIS WITH SHORT COURSE LEVOFLOXACIN A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2005
Overall Recruitment Status
Terminated
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Manitoba
Collaborators
Ortho-McNeil Pharmaceutical, Janssen-Ortho Inc., Canada, PriCara, Unit of Ortho-McNeil, Inc.

4. Oversight

5. Study Description

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.
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: To assess the efficacy and tolerability of levofloxacin 750 mg once daily for treatment of acute uncomplicated pyelonephritis in 25 women. To describe the population pharmacokinetics of levofloxacin 750 mg once daily in treatment of young women with acute pyelonephritis. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Uncomplicated Pyelonephritis
Keywords
Pyelonephritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Levofloxacin
Primary Outcome Measure Information:
Title
Microbiological cure at the 10-14 day and 33-35 day followup
Secondary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lindsay E Nicolle, MD, FRCPC
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Godfrey KM Harding, MD, FRCPC
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
George G Zhanel, PhD, FCCP
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Boniface General Hospital
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada
Facility Name
Health Sciences Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
Facility Name
Misericordia Urgent Care
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3C 1A2
Country
Canada
Facility Name
University of Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0W3
Country
Canada

12. IPD Sharing Statement

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

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