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

Sponsor:	University of Manitoba
Information provided by:	University of Manitoba
ClinicalTrials.gov Identifier:	NCT00245791

Purpose

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	Intervention	Phase
Complicated Urinary Infection	Drug: Levofloxacin	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	TREATMENT OF COMPLICATED URINARY INFECTION WITH FIVE DAY HIGH DOSE LEVOFLOXACIN

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Urinary Tract Infections

Drug Information available for: Ofloxacin Levofloxacin Ofloxacin hydrochloride

U.S. FDA Resources

Further study details as provided by University of Manitoba:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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.

Estimated Enrollment:	30
Study Start Date:	October 2004
Estimated Study Completion Date:	July 2005

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:

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00245791

Locations

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

Sponsors and Collaborators

University of Manitoba

Investigators

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

More Information

No publications provided

Study ID Numbers:	CAPSS-383, LOF-UTI-3
Study First Received:	October 27, 2005
Last Updated:	October 27, 2005
ClinicalTrials.gov Identifier:	NCT00245791 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by University of Manitoba:

Complicated Urinary Infection

Additional relevant MeSH terms:

Communicable Diseases
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Urinary Tract Infections
Ofloxacin
Enzyme Inhibitors
Anti-Infective Agents, Urinary

Renal Agents
Infection
Pharmacologic Actions
Anti-Bacterial Agents
Urologic Diseases
Therapeutic Uses
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on February 09, 2010