Clinical trial NCT00245791: Urinary Tract Infection Study With the Antibiotic Levofloxacin Given at a Higher Dose Over a Shorter Period of Time
Official title: TREATMENT OF COMPLICATED URINARY INFECTION WITH FIVE DAY HIGH DOSE LEVOFLOXACIN
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Complicated Urinary Infection
Keywords: Complicated Urinary Infection
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2005-10-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Microbiologic and clinical cure at the early post-therapy follow-up visit (12-19 days after initiating antimicrobial).
Secondary outcomes:
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.
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: St. Boniface General Hospital
state: Manitoba
city: Winnipeg
country: Canada
facility: Health Sciences Centre
state: Manitoba
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Lindsay E Nicolle, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Manitoba
name: Godfrey KP Harding, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Manitoba
name: George G Zhanel, PhD, FCCP
role: PRINCIPAL_INVESTIGATOR
References: