Levofloxacin as an Empirical Therapy in Patients With Complicated Urinary Tract Infections
NCT ID: NCT03160807
Last Updated: 2017-05-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
214 participants
INTERVENTIONAL
2017-04-15
2018-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Levofloxacin 5 days
Levolet 500 mg given for 5 days
Levofloxacin
Levolet 500 mg OD for 5 days
Levofloxacin 10 days
Levolet 500 mg given for 10 days
Levofloxacin
Levolet 500 OD for 10 days
Interventions
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Levofloxacin
Levolet 500 mg OD for 5 days
Levofloxacin
Levolet 500 OD for 10 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
19 Years
70 Years
ALL
No
Sponsors
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Dr. Reddy's Laboratories Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Dr Ilyas Tungiskhanovich
Role: PRINCIPAL_INVESTIGATOR
Scientific Centre of Urology named after B.U Dzharbusynov 2, Basenov street, Almaty 050060, Republic of Kazakhstan
Locations
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Scientific Centre of Urology named after B.U Dzharbusynov 2, Basenov street,
Almaty, , Kazakhstan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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EM_KZ_LEVOLET
Identifier Type: -
Identifier Source: org_study_id
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