search
Back to results

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

Primary Purpose

Urinary Tract Infection

Status
Unknown status
Phase
Phase 4
Locations
Kazakhstan
Study Type
Interventional
Intervention
Levofloxacin
Levofloxacin
Sponsored by
Dr. Reddy's Laboratories Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Tract Infection

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Levofloxacin 5 days

Levofloxacin 10 days

Arm Description

Levolet 500 mg given for 5 days

Levolet 500 mg given for 10 days

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
No. of adverse events in entire study duration
Type and total number of AEs recorded in study duration
Percentage of patient compliant to therapy in each study arm.
Percentage of patients compliant to study treatment
Percentage of patient samples sensitive to levofloxacin in each study arm.
Percent sensitivity

Full Information

First Posted
June 28, 2016
Last Updated
May 18, 2017
Sponsor
Dr. Reddy's Laboratories Limited
search

1. Study Identification

Unique Protocol Identification Number
NCT03160807
Brief Title
Levofloxacin as an Empirical Therapy in Patients With Complicated Urinary Tract Infections
Acronym
Levolet-KZ16
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 15, 2017 (Actual)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
March 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dr. Reddy's Laboratories Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
214 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Levofloxacin 5 days
Arm Type
Experimental
Arm Description
Levolet 500 mg given for 5 days
Arm Title
Levofloxacin 10 days
Arm Type
Active Comparator
Arm Description
Levolet 500 mg given for 10 days
Intervention Type
Drug
Intervention Name(s)
Levofloxacin
Other Intervention Name(s)
Levolet 500
Intervention Description
Levolet 500 mg OD for 5 days
Intervention Type
Drug
Intervention Name(s)
Levofloxacin
Other Intervention Name(s)
Levolet 500
Intervention Description
Levolet 500 OD for 10 days
Primary Outcome Measure Information:
Title
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
Description
Cure: a complete resolution of clinically significant signs & symptoms
Time Frame
Baseline to 5 days
Secondary Outcome Measure Information:
Title
Percentage of patients with microbiological eradication at test of cure visit (TOC)
Description
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
Title
No. of adverse events in entire study duration
Description
Type and total number of AEs recorded in study duration
Time Frame
Baseline to EOT visit (Baseline to 15 days)
Title
Percentage of patient compliant to therapy in each study arm.
Description
Percentage of patients compliant to study treatment
Time Frame
Baseline to EOT visit (Baseline to 15 days)
Title
Percentage of patient samples sensitive to levofloxacin in each study arm.
Description
Percent sensitivity
Time Frame
Baseline to EOT (Baseline to 15 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
SUHAS S KHANDARKAR
Phone
04049002419
Ext
2419
Email
suhassk@drreddys.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Ilyas Tungiskhanovich
Organizational Affiliation
Scientific Centre of Urology named after B.U Dzharbusynov 2, Basenov street, Almaty 050060, Republic of Kazakhstan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Scientific Centre of Urology named after B.U Dzharbusynov 2, Basenov street,
City
Almaty
ZIP/Postal Code
050060
Country
Kazakhstan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ilyas Tungiskhanovich
Phone
+7727 337 8492
Email
22iliyas@mail.ru

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

We'll reach out to this number within 24 hrs