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

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ClinicalTrials.gov Identifier: NCT03160807
Recruitment Status : Recruiting
First Posted : May 19, 2017
Last Update Posted : May 19, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited

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

Condition or disease Intervention/treatment Phase
Urinary Tract Infection Drug: Levofloxacin 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.


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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 15, 2017
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Levofloxacin 5 days
Levolet 500 mg given for 5 days
Drug: Levofloxacin
Levolet 500 mg OD for 5 days
Other Name: Levolet 500

Active Comparator: Levofloxacin 10 days
Levolet 500 mg given for 10 days
Drug: Levofloxacin
Levolet 500 OD for 10 days
Other Name: Levolet 500




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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: Baseline to EOT (Baseline to 15 days) ]
    Percent sensitivity



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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03160807


Contacts
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Contact: SUHAS S KHANDARKAR 04049002419 ext 2419 suhassk@drreddys.com

Locations
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Kazakhstan
Scientific Centre of Urology named after B.U Dzharbusynov 2, Basenov street, Recruiting
Almaty, Kazakhstan, 050060
Contact: Ilyas Tungiskhanovich    +7727 337 8492    22iliyas@mail.ru   
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
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Principal Investigator: Dr Ilyas Tungiskhanovich Scientific Centre of Urology named after B.U Dzharbusynov 2, Basenov street, Almaty 050060, Republic of Kazakhstan

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Responsible Party: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT03160807     History of Changes
Other Study ID Numbers: EM_KZ_LEVOLET
First Posted: May 19, 2017    Key Record Dates
Last Update Posted: May 19, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Urinary Tract Infections
Urologic Diseases
Levofloxacin
Ofloxacin
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors