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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 : Unknown
Verified May 2017 by Dr. Reddy's Laboratories Limited.
Recruitment status was:  Recruiting
First Posted : May 19, 2017
Last Update Posted : May 19, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited

Tracking Information
First Submitted Date  ICMJE June 28, 2016
First Posted Date  ICMJE May 19, 2017
Last Update Posted Date May 19, 2017
Actual Study Start Date  ICMJE April 15, 2017
Estimated Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 18, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 18, 2017)
  • 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
  • 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
  • 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
  • Percentage of patient samples sensitive to levofloxacin in each study arm. [ Time Frame: Baseline to EOT (Baseline to 15 days) ]
    Percent sensitivity
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Levofloxacin as an Empirical Therapy in Patients With Complicated Urinary Tract Infections
Official Title  ICMJE An Open Label Non Placebo Study to Evaluate Efficacy and Safety of Levofloxacin as an Empirical Therapy in Patients With Complicated Urinary Tract Infections
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Urinary Tract Infection
Intervention  ICMJE
  • Drug: Levofloxacin
    Levolet 500 mg OD for 5 days
    Other Name: Levolet 500
  • Drug: Levofloxacin
    Levolet 500 OD for 10 days
    Other Name: Levolet 500
Study Arms  ICMJE
  • Experimental: Levofloxacin 5 days
    Levolet 500 mg given for 5 days
    Intervention: Drug: Levofloxacin
  • Active Comparator: Levofloxacin 10 days
    Levolet 500 mg given for 10 days
    Intervention: Drug: Levofloxacin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 18, 2017)
214
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2018
Estimated Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Kazakhstan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03160807
Other Study ID Numbers  ICMJE EM_KZ_LEVOLET
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Dr. Reddy's Laboratories Limited
Study Sponsor  ICMJE Dr. Reddy's Laboratories Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dr Ilyas Tungiskhanovich Scientific Centre of Urology named after B.U Dzharbusynov 2, Basenov street, Almaty 050060, Republic of Kazakhstan
PRS Account Dr. Reddy's Laboratories Limited
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP