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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT03160807 |
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Date of registration:
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28/06/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Levofloxacin as an Empirical Therapy in Patients With Complicated Urinary Tract Infections
Levolet-KZ16 |
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Scientific title:
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An Open Label Non Placebo Study to Evaluate Efficacy and Safety of Levofloxacin as an Empirical Therapy in Patients With Complicated Urinary Tract Infections |
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Date of first enrolment:
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April 15, 2017 |
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Target sample size:
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214 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03160807 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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Kazakhstan
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Contacts
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Name:
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Ilyas Tungiskhanovich |
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Address:
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Telephone:
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+7727 337 8492 |
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Email:
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22iliyas@mail.ru |
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Affiliation:
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Name:
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SUHAS S KHANDARKAR |
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Address:
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Telephone:
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04049002419 |
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Email:
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suhassk@drreddys.com |
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Affiliation:
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Name:
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Dr Ilyas Tungiskhanovich |
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Address:
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Telephone:
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Email:
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Affiliation:
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Scientific Centre of Urology named after B.U Dzharbusynov 2, Basenov street, Almaty 050060, Republic of Kazakhstan |
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Key inclusion & exclusion criteria
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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
Age minimum:
19 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Urinary Tract Infection
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Intervention(s)
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Drug: Levofloxacin
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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No. of adverse events in entire study duration
[Time Frame: Baseline to EOT visit (Baseline to 15 days)]
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Percentage of patient samples sensitive to levofloxacin in each study arm.
[Time Frame: Baseline to EOT (Baseline to 15 days)]
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Percentage of patients with microbiological eradication at test of cure visit (TOC)
[Time Frame: Baseline to 5 days and upto 10 days]
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Percentage of patient compliant to therapy in each study arm.
[Time Frame: Baseline to EOT visit (Baseline to 15 days)]
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Secondary ID(s)
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EM_KZ_LEVOLET
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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