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

Complicated Urinary Infection Clinical Trial

Official title:

TREATMENT OF COMPLICATED URINARY INFECTION WITH FIVE DAY HIGH DOSE LEVOFLOXACIN

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00245791
• Other study ID #: CAPSS-383
• Secondary ID: LOF-UTI-3
• Status: Terminated
• Phase: Phase 4
• First received: October 27, 2005
• Last updated: June 2, 2015
• Start date: October 2004
• Est. completion date: July 2005

Study information

• Verified date: August 2005
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: July 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

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

• Communicable Diseases
• Complicated Urinary Infection
• Infection
• Urinary Tract Infections

Intervention

Drug:
• Levofloxacin

Locations

Country	Name	City	State
Canada	Health Sciences Centre	Winnipeg	Manitoba
Canada	St. Boniface General Hospital	Winnipeg	Manitoba
Canada	University of Manitoba	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microbiologic and clinical cure at the early post-therapy follow-up visit (12-19 days after initiating antimicrobial).
Secondary	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.