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

Sponsor
Dr. Reddy's Laboratories Limited (Industry)
Overall Status
Unknown status
CT.gov ID
NCT03160807
Collaborator
(none)
214
Enrollment
1
Location
2
Arms
10.5
Anticipated Duration (Months)
20.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
214 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Apr 15, 2017
Anticipated Primary Completion Date :
Mar 1, 2018
Anticipated Study Completion Date :
Mar 1, 2018

Arms and Interventions

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

    		•
    Active Comparator: Levofloxacin 10 days

    Levolet 500 mg given for 10 days

    Drug: Levofloxacin
    Levolet 500 OD for 10 days
    Other Names:
  • Levolet 500

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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 [Baseline to 5 days]

      Cure: a complete resolution of clinically significant signs & symptoms

    Secondary Outcome Measures

    1. Percentage of patients with microbiological eradication at test of cure visit (TOC) [Baseline to 5 days and upto 10 days]

      Eradication: All uropathogens present at ≥105 CFU/ml at baseline had been reduced to <104 CFU/ml

    2. No. of adverse events in entire study duration [Baseline to EOT visit (Baseline to 15 days)]

      Type and total number of AEs recorded in study duration

    3. Percentage of patient compliant to therapy in each study arm. [Baseline to EOT visit (Baseline to 15 days)]

      Percentage of patients compliant to study treatment

    4. Percentage of patient samples sensitive to levofloxacin in each study arm. [Baseline to EOT (Baseline to 15 days)]

      Percent sensitivity

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Scientific Centre of Urology named after B.U Dzharbusynov 2, Basenov street, Almaty Kazakhstan 050060

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Reddy's Laboratories Limited
    ClinicalTrials.gov Identifier:
    NCT03160807
    Other Study ID Numbers:
    • EM_KZ_LEVOLET
    First Posted:
    May 19, 2017
    Last Update Posted:
    May 19, 2017
    Last Verified:
    May 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    Urinary Tract Infections
    Levofloxacin
    Ofloxacin

    Study Results

    No Results Posted as of May 19, 2017