Back to resultsUrinary Tract Infection Study With the Antibiotic Levofloxacin Given at a Higher Dose Over a Shorter Period of Time
Primary Purpose
Complicated Urinary Infection
Status
Terminated
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Levofloxacin
Sponsored by
About this trial
This is an interventional treatment trial for Complicated Urinary Infection focused on measuring Complicated Urinary Infection
Eligibility Criteria
Inclusion Criteria: Acute symptoms of urinary infection of less than 7 days duration and an underlying structural or functional abnormality of the genitourinary tract. Pre-therapy urine culture > 105 cfu/ml (> 108 cfu/L) of at least one urinary pathogen. Age 18-80 years, male or female. Exclusion Criteria: Prior allergic reaction to any fluoroquinolone antimicrobial. Known infection with a fluoroquinolone - resistant organism. Requiring parenteral therapy because of severity of illness or unable to take oral medications. Women who are pregnant or breastfeeding. Requiring additional antimicrobial therapy for infections elsewhere.
Sites / Locations
- St. Boniface General Hospital
- Health Sciences Centre
- University of Manitoba
Outcomes
Primary Outcome Measures
Microbiologic and clinical cure at the early post-therapy follow-up visit (12-19 days after initiating antimicrobial).
Secondary Outcome Measures
Variables will include outcomes at 2 days of therapy, failure to complete therapy, adverse drug effects, long term clinical and microbiologic outcomes, and emergence of resistant organisms.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00245791
Brief Title
Urinary Tract Infection Study With the Antibiotic Levofloxacin Given at a Higher Dose Over a Shorter Period of Time
Official Title
TREATMENT OF COMPLICATED URINARY INFECTION WITH FIVE DAY HIGH DOSE LEVOFLOXACIN
Study Type
Interventional
2. Study Status
Record Verification Date
August 2005
Overall Recruitment Status
Terminated
Study Start Date
October 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Manitoba
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 and using a shorter course of therapy.
Detailed Description
This study will be a pilot study of the efficacy of 750 mg of levofloxacin once daily for 5 days in the treatment of complicated urinary tract infection.
The specific objectives include:
To describe clinical and microbiological outcome at short and long term follow-up with 5 days levofloxacin in subjects with acute symptomatic complicated urinary infection, both with and without indwelling catheters.
To determine the tolerability of levofloxacin 750-mg once daily in patients with complicated urinary infection.
To describe some characteristics of the resolution of the inflammatory response with treatment of complicated urinary infection as demonstrated by changes in urine proteins.
To identify any emergence of resistant organisms in recurrent urinary infection following therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complicated Urinary Infection
Keywords
Complicated Urinary Infection
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
Microbiologic and clinical cure at the early post-therapy follow-up visit (12-19 days after initiating antimicrobial).
Secondary Outcome Measure Information:
Title
Variables will include outcomes at 2 days of therapy, failure to complete therapy, adverse drug effects, long term clinical and microbiologic outcomes, and emergence of resistant organisms.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Acute symptoms of urinary infection of less than 7 days duration and an underlying structural or functional abnormality of the genitourinary tract.
Pre-therapy urine culture > 105 cfu/ml (> 108 cfu/L) of at least one urinary pathogen.
Age 18-80 years, male or female.
Exclusion Criteria:
Prior allergic reaction to any fluoroquinolone antimicrobial.
Known infection with a fluoroquinolone - resistant organism.
Requiring parenteral therapy because of severity of illness or unable to take oral medications.
Women who are pregnant or breastfeeding.
Requiring additional antimicrobial therapy for infections elsewhere.
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 KP 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
University of Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0W3
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Urinary Tract Infection Study With the Antibiotic Levofloxacin Given at a Higher Dose Over a Shorter Period of Time
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