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

Dr. Reddy's Laboratories Limited214 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

214

Conditions

Urinary Tract Infection

Interventions

LevofloxacinDRUG

Levolet 500 mg OD for 5 days

LevofloxacinDRUG

Levolet 500 OD for 10 days

Eligibility

Sex: ALLMin age: 19 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Scientific Centre of Urology named after B.U Dzharbusynov 2, Basenov street,

Almaty, Kazakhstan

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: Baseline to 5 days

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: Baseline to EOT visit (Baseline to 15 days)

Percentage of patient samples sensitive to levofloxacin in each study arm.

Percent sensitivity

Time frame: Baseline to EOT (Baseline to 15 days)

Central Contacts

SUHAS S KHANDARKAR

CONTACT

04049002419 suhassk@drreddys.com

Data from ClinicalTrials.gov

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