Urinary Tract Infection Study With the Antibiotic Levofloxacin Given at a Higher Dose Over a Shorter Period of Time
|ClinicalTrials.gov Identifier: NCT00245791|
Recruitment Status : Terminated
First Posted : October 28, 2005
Last Update Posted : June 3, 2015
|Condition or disease||Intervention/treatment||Phase|
|Complicated Urinary Infection||Drug: Levofloxacin||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||TREATMENT OF COMPLICATED URINARY INFECTION WITH FIVE DAY HIGH DOSE LEVOFLOXACIN|
|Study Start Date :||October 2004|
|Estimated Study Completion Date :||July 2005|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00245791
|St. Boniface General Hospital|
|Winnipeg, Manitoba, Canada, R2H 2A6|
|Health Sciences Centre|
|Winnipeg, Manitoba, Canada, R3A 1R9|
|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|