Levofloxacin as an Empirical Therapy in Patients With Complicated Urinary Tract Infections

Study Overview
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Brief Summary
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Study is planned to evaluate safety and efficacy of Levolet in patients with complicated UTI

Detailed Description
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A complicated urinary tract infection is a urinary infection occurring in a patient with a structural or functional abnormality of the genitourinary tract. Fluoroquinolones have been recommended as the antimicrobials of choice for the empirical treatment of complicated urinary tract. Levofloxacin is a broad spectrum agent, which is known to demonstrate good clinical efficacy against urinary tract infection (UTI). There is no published evidence available on the empirical use of Levofloxacin 500 mg OD and its optimal duration of therapy in patients with Complicated Urinary Tract Infections (cUTI). The present study evaluates the efficacy and safety, and optimal duration of therapy of levofloxacin 500 mg OD in patients with complicated UTI.

Official Title
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An Open Label Non Placebo Study to Evaluate Efficacy and Safety of Levofloxacin as an Empirical Therapy in Patients With Complicated Urinary Tract Infections

Conditions
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Urinary Tract Infection

Intervention / Treatment
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* Drug: Levofloxacin
* Drug: Levofloxacin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or non-pregnant women over 18 years of age with cUTI in One or more clinical symptoms and signs of a lower UTI: fever (> 38°C, orally), chills, frequency of micturition, dysuria, urge sensation. One or more of the following underlying conditions suggestive of cUTI: Indwelling urinary catheter. Neurogenic bladder. Obstructive uropathy due to lithiasis, tumor or fibrosis. Acute urinary retention in men Exclusion Criteria: History of allergy to quinolones Are unable to take oral medication Have an intractable infection requiring > 14 days of therapy Have a requirement for concomitant administration of sucralfate or divalent and trivalent cations such as iron or antacids containing magnesium, aluminum or calcium Have prostatitis or epididymitis Have had a renal transplant Have ileal loop or vesica- urethral reflux Have significant liver or kidney impairment Have a history of tendinopathy associated with fluoroquinolones Are pregnant, nursing Have a history of convulsions or CNS disorders

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Levofloxacin 5 days<br>Levolet 500 mg given for 5 days | Drug: Levofloxacin<br>* Levolet 500 mg OD for 5 days<br>* Other names: Levolet 500;|
| Active Comparator: Levofloxacin 10 days<br>Levolet 500 mg given for 10 days | Drug: Levofloxacin<br>* Levolet 500 OD for 10 days<br>* Other names: Levolet 500;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with clinical cure rates at test of cure visit (TOC) defined as follows- Cure: a complete resolution of clinically significant signs & symptoms | Cure: a complete resolution of clinically significant signs & symptoms | Baseline to 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with microbiological eradication at test of cure visit (TOC) | Eradication: All uropathogens present at ≥105 CFU/ml at baseline had been reduced to <104 CFU/ml | Baseline to 5 days and upto 10 days | 
| No. of adverse events in entire study duration | Type and total number of AEs recorded in study duration | Baseline to EOT visit (Baseline to 15 days) | 
| Percentage of patient compliant to therapy in each study arm. | Percentage of patients compliant to study treatment | Baseline to EOT visit (Baseline to 15 days) | 
| Percentage of patient samples sensitive to levofloxacin in each study arm. | Percent sensitivity | Baseline to EOT (Baseline to 15 days) |