Urinary Tract Infection
Conditions
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.
Interventions
DRUGLevofloxacin
Levolet 500 mg OD for 5 days
Sponsors
Dr. Reddy's Laboratories Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline to 5 days | Cure: a complete resolution of clinically significant signs & symptoms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with microbiological eradication at test of cure visit (TOC) | 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 | 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. | 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. | Baseline to EOT (Baseline to 15 days) | Percent sensitivity |
Countries
Kazakhstan
Contacts
Primary ContactSUHAS S KHANDARKAR
Outcome results
None listed