Levofloxacin as an Empirical Therapy in Patients With Complicated Urinary Tract Infections (Levolet-KZ16)

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

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

Study Overview

• Status: Unknown
• Conditions: Urinary Tract Infection
• Intervention / Treatment: Drug: Levofloxacin; Drug: Levofloxacin

Detailed Description

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
• Enrollment (Anticipated): 214
• Phase: Phase 4

Contacts and Locations

Study Locations

• Kazakhstan
  • Almaty, Kazakhstan, 050060
    • Recruiting
    • Scientific Centre of Urology named after B.U Dzharbusynov 2, Basenov street,
    • Contact: Ilyas Tungiskhanovich; Phone Number: +7727 337 8492; Email: 22iliyas@mail.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Levofloxacin 5 days; Levolet 500 mg given for 5 days	Drug: Levofloxacin; Levolet 500 mg OD for 5 days; Other Names: Levolet 500; Drug: Levofloxacin; Levolet 500 OD for 10 days; Other Names: Levolet 500
Active Comparator: Levofloxacin 10 days; Levolet 500 mg given for 10 days	Drug: Levofloxacin; Levolet 500 mg OD for 5 days; Other Names: Levolet 500; Drug: Levofloxacin; Levolet 500 OD for 10 days; Other Names: Levolet 500

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Dr. Reddy's Laboratories Limited
• Investigators: Principal Investigator: Dr Ilyas Tungiskhanovich, Scientific Centre of Urology named after B.U Dzharbusynov 2, Basenov street, Almaty 050060, Republic of Kazakhstan

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2017
• Primary Completion (Anticipated): March 1, 2018
• Study Completion (Anticipated): March 1, 2018

Study Registration Dates

• First Submitted: June 28, 2016
• First Submitted That Met QC Criteria: May 18, 2017
• First Posted (Actual): May 19, 2017

Study Record Updates

• Last Update Posted (Actual): May 19, 2017
• Last Update Submitted That Met QC Criteria: May 18, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Infections; Communicable Diseases; Urinary Tract Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Anti-Infective Agents, Urinary; Renal Agents; Levofloxacin; Ofloxacin
• Other Study ID Numbers: EM_KZ_LEVOLET

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No