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Clinical Trial 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 Trial 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. ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00245791
Study type Interventional
Source University of Manitoba
Contact
Status Terminated
Phase Phase 4
Start date October 2004
Completion date July 2005