Urinary Tract Infection Study With the Antibiotic Levofloxacin Given at a Higher Dose Over a Shorter Period of Time
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||TREATMENT OF COMPLICATED URINARY INFECTION WITH FIVE DAY HIGH DOSE LEVOFLOXACIN|
- Microbiologic and clinical cure at the early post-therapy follow-up visit (12-19 days after initiating antimicrobial).
- 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.
|Study Start Date:||October 2004|
|Estimated Study Completion Date:||July 2005|
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.
|Health Sciences Centre|
|Winnipeg, Manitoba, Canada, R3A 1R9|
|St. Boniface General Hospital|
|Winnipeg, Manitoba, Canada, R2H 2A6|
|University of Manitoba|
|Winnipeg, Manitoba, Canada, R3E 0W3|
|Principal Investigator:||Lindsay E Nicolle, MD, FRCPC||University of Manitoba|
|Principal Investigator:||Godfrey KP Harding, MD, FRCPC||University of Manitoba|
|Principal Investigator:||George G Zhanel, PhD, FCCP||University of Manitoba|