Levofloxacin as an Empirical Therapy in Patients With Complicated Urinary Tract Infections

Urinary Tract Infection Clinical Trial

— Levolet-KZ16  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03160807
• Other study ID #: EM_KZ_LEVOLET
• Status: Recruiting
• Phase: Phase 4
• First received: June 28, 2016
• Last updated: May 18, 2017
• Start date: April 15, 2017
• Est. completion date: March 2018

Study information

• Verified date: May 2017
• Source: Dr. Reddy's Laboratories Limited
• Contact: SUHAS S KHANDARKAR
• Phone: 04049002419
• Email: suhassk[@]drreddys.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study is planned to evaluate safety and efficacy of Levolet in patients with complicated UTI

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 214
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Urinary Tract Infection
• Urinary Tract Infections

Intervention

Drug:
• Levofloxacin
Levolet 500 mg OD for 5 days
• Levofloxacin
Levolet 500 OD for 10 days

Locations

Country	Name	City	State
Kazakhstan	Scientific Centre of Urology named after B.U Dzharbusynov 2, Basenov street,	Almaty

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Reddy's Laboratories Limited

Country where clinical trial is conducted

Kazakhstan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cure: a complete resolution of clinically significant signs & symptoms	Baseline to 5 days
Secondary	Percentage of patients with microbiological eradication at test of cure visit (TOC)	Eradication: All uropathogens present at =105 CFU/ml at baseline had been reduced to <104 CFU/ml	Baseline to 5 days and upto 10 days
Secondary	No. of adverse events in entire study duration	Type and total number of AEs recorded in study duration	Baseline to EOT visit (Baseline to 15 days)
Secondary	Percentage of patient compliant to therapy in each study arm.	Percentage of patients compliant to study treatment	Baseline to EOT visit (Baseline to 15 days)
Secondary	Percentage of patient samples sensitive to levofloxacin in each study arm.	Percent sensitivity	Baseline to EOT (Baseline to 15 days)