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
|Condition or disease||Intervention/treatment||Phase|
|Urinary Tract Infection||Drug: Levofloxacin||Phase 4|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||214 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Levofloxacin 5 days
Levolet 500 mg given for 5 days
Levolet 500 mg OD for 5 days
Other Name: Levolet 500
Active Comparator: Levofloxacin 10 days
Levolet 500 mg given for 10 days
Levolet 500 OD for 10 days
Other Name: Levolet 500
- 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
- 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
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
|Contact: SUHAS S KHANDARKAR||04049002419 ext firstname.lastname@example.org|
|Scientific Centre of Urology named after B.U Dzharbusynov 2, Basenov street,||Recruiting|
|Almaty, Kazakhstan, 050060|
|Contact: Ilyas Tungiskhanovich +7727 337 8492 email@example.com|
|Principal Investigator:||Dr Ilyas Tungiskhanovich||Scientific Centre of Urology named after B.U Dzharbusynov 2, Basenov street, Almaty 050060, Republic of Kazakhstan|