Urinary Tract Infection Study With the Antibiotic Levofloxacin Given at a Higher Dose Over a Shorter Period of Time
Information source: University of Manitoba
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Complicated Urinary Infection
Intervention: Levofloxacin (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: University of Manitoba Official(s) and/or principal investigator(s):
Lindsay E Nicolle, MD, FRCPC, Principal Investigator, Affiliation: University of Manitoba
Godfrey KP Harding, MD, FRCPC, Principal Investigator, Affiliation: University of Manitoba
George G Zhanel, PhD, FCCP, Principal Investigator, Affiliation: University of Manitoba
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.
Clinical Details
Official title: TREATMENT OF COMPLICATED URINARY INFECTION WITH FIVE DAY HIGH DOSE LEVOFLOXACIN
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Microbiologic and clinical cure at the early post-therapy follow-up visit (12-19 days after initiating antimicrobial).
Secondary outcome: 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.
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:
1. 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.
2. To determine the tolerability of levofloxacin 750-mg once daily in patients with
complicated urinary infection.
3. To describe some characteristics of the resolution of the inflammatory response with
treatment of complicated urinary infection as demonstrated by changes in urine
proteins.
4. To identify any emergence of resistant organisms in recurrent urinary infection
following therapy.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Acute symptoms of urinary infection of less than 7 days duration and an underlying
structural or functional abnormality of the genitourinary tract.
2. Pre-therapy urine culture > 105 cfu/ml (> 108 cfu/L) of at least one urinary
pathogen.
3. Age 18-80 years, male or female.
Exclusion Criteria:
1. Prior allergic reaction to any fluoroquinolone antimicrobial.
2. Known infection with a fluoroquinolone - resistant organism.
3. Requiring parenteral therapy because of severity of illness or unable to take oral
medications.
4. Women who are pregnant or breastfeeding.
5. Requiring additional antimicrobial therapy for infections elsewhere.
Locations and Contacts
Health Sciences Centre, Winnipeg, Manitoba R3A 1R9, Canada
St. Boniface General Hospital, Winnipeg, Manitoba R2H 2A6, Canada
University of Manitoba, Winnipeg, Manitoba R3E 0W3, Canada
Additional Information
Starting date: October 2004
Ending date: July 2005
Last updated: October 27, 2005
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