Complicated Urinary Infection
Conditions
Keywords
Complicated Urinary Infection
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: 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.
Interventions
DRUGLevofloxacin
Sponsors
University of Manitoba
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Microbiologic and clinical cure at the early post-therapy follow-up visit (12-19 days after initiating antimicrobial). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Canada
Outcome results
None listed