Urinary Tract Infection Study With the Antibiotic Levofloxacin Given at a Higher Dose Over a Shorter Period of Time

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00245791
Recruitment Status : Terminated
First Posted : October 28, 2005
Last Update Posted : June 3, 2015
Information provided by:
University of Manitoba

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.

Condition or disease Intervention/treatment Phase
Complicated Urinary Infection Drug: Levofloxacin Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2004
Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Microbiologic and clinical cure at the early post-therapy follow-up visit (12-19 days after initiating antimicrobial).

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00245791

Canada, Manitoba
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
Sponsors and Collaborators
University of Manitoba
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 Identifier: NCT00245791     History of Changes
Other Study ID Numbers: CAPSS-383
First Posted: October 28, 2005    Key Record Dates
Last Update Posted: June 3, 2015
Last Verified: August 2005

Keywords provided by University of Manitoba:
Complicated Urinary Infection

Additional relevant MeSH terms:
Communicable Diseases
Urinary Tract Infections
Urologic Diseases
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors