NCT00245791

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2004

Shorter than P25 for phase_4

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 2005

Completed
Last Updated

June 3, 2015

Status Verified

August 1, 2005

First QC Date

October 27, 2005

Last Update Submit

June 2, 2015

Conditions

Complicated Urinary Infection

Keywords

Complicated Urinary Infection

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (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.

Interventions

LevofloxacinDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute symptoms of urinary infection of less than 7 days duration and an underlying structural or functional abnormality of the genitourinary tract.
  • Pre-therapy urine culture \> 105 cfu/ml (\> 108 cfu/L) of at least one urinary pathogen.
  • Age 18-80 years, male or female.

You may not qualify if:

  • Prior allergic reaction to any fluoroquinolone antimicrobial.
  • Known infection with a fluoroquinolone - resistant organism.
  • Requiring parenteral therapy because of severity of illness or unable to take oral medications.
  • Women who are pregnant or breastfeeding.
  • Requiring additional antimicrobial therapy for infections elsewhere.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

St. Boniface General Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Health Sciences Centre

Winnipeg, Manitoba, R3A 1R9, Canada

Location

University of Manitoba

Winnipeg, Manitoba, R3E 0W3, Canada

Location

MeSH Terms

Interventions

Levofloxacin

Intervention Hierarchy (Ancestors)

OfloxacinFluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 27, 2005

First Posted

October 28, 2005

Study Start

October 1, 2004

Study Completion

July 1, 2005

Last Updated

June 3, 2015

Record last verified: 2005-08

Locations

CA(3)