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

TREATMENT OF COMPLICATED URINARY INFECTION WITH FIVE DAY HIGH DOSE LEVOFLOXACIN

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 Overview

• Status: Terminated
• Conditions: Complicated Urinary Infection
• Intervention / Treatment: Drug: Levofloxacin

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
• Enrollment: 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2H 2A6
      • St. Boniface General Hospital
    • Winnipeg, Manitoba, Canada, R3A 1R9
      • Health Sciences Centre
    • Winnipeg, Manitoba, Canada, R3E 0W3
      • University of Manitoba

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

• Sponsor: University of Manitoba
• Investigators: Principal Investigator: Godfrey KP Harding, MD, FRCPC, University of Manitoba

Study record dates

Study Major Dates

• Study Start: October 1, 2004
• Primary Completion: December 7, 2022
• Study Completion: July 1, 2005

Study Registration Dates

• First Submitted: October 27, 2005
• First Submitted That Met QC Criteria: October 27, 2005
• First Posted (Estimate): October 28, 2005

Study Record Updates

• Last Update Posted (Estimate): June 3, 2015
• Last Update Submitted That Met QC Criteria: June 2, 2015
• Last Verified: August 1, 2005

More Information

Terms related to this study

• Keywords: Complicated Urinary Infection
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Infections; Communicable Diseases; Urinary Tract Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Anti-Infective Agents, Urinary; Renal Agents; Levofloxacin; Ofloxacin
• Other Study ID Numbers: CAPSS-383; LOF-UTI-3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No