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

Study Overview
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Brief Summary
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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
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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.

Official Title
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TREATMENT OF COMPLICATED URINARY INFECTION WITH FIVE DAY HIGH DOSE LEVOFLOXACIN

Conditions
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Complicated Urinary Infection

Intervention / Treatment
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* Drug: Levofloxacin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Levofloxacin|nan|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Complicated Urinary Infection