Clinical trial NCT03160807: Levofloxacin as an Empirical Therapy in Patients With Complicated Urinary Tract Infections
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Urinary Tract Infection
Lead sponsor: Dr. Reddy's Laboratories Limited
Sponsor class: INDUSTRY
First posted: 2017-05-19
Enrollment: 214
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Baseline to 5 days
Secondary outcomes:
measure: Percentage of patients with microbiological eradication at test of cure visit (TOC)
timeFrame: Baseline to 5 days and upto 10 days
measure: No. of adverse events in entire study duration
timeFrame: Baseline to EOT visit (Baseline to 15 days)
measure: Percentage of patient compliant to therapy in each study arm.
timeFrame: Baseline to EOT visit (Baseline to 15 days)
measure: Percentage of patient samples sensitive to levofloxacin in each study arm.
timeFrame: Baseline to EOT (Baseline to 15 days)
Other outcomes:
Locations:
city: Almaty
country: Kazakhstan
facility: Scientific Centre of Urology named after B.U Dzharbusynov 2, Basenov street,
Study officials:
affiliation: Scientific Centre of Urology named after B.U Dzharbusynov 2, Basenov street, Almaty 050060, Republic of Kazakhstan
name: Dr Ilyas Tungiskhanovich
role: PRINCIPAL_INVESTIGATOR
References: