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

Phase 4

• Conditions: Urinary Tract Infection
• Interventions: Drug: Levofloxacin

• Registration Number: NCT03160807
• Lead Sponsor: Dr. Reddy's Laboratories Limited

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.

Study Timeline

• Study First Submitted: 2016-06-28
• Study Start: 2017-04-15
• Status Verified: 2017-05
• Study First Submitted QC: 2017-05-18
• Last Update Submitted: 2017-05-18
• Study First Posted: 2017-05-19
• Last Update Posted: 2017-05-19
• Primary Completion: 2018-03
• Study Completion: 2018-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 214

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Levofloxacin 10 days	Levofloxacin	Levolet 500 mg given for 10 days
Levofloxacin 5 days	Levofloxacin	Levolet 500 mg given for 5 days

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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
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

Trial Locations

Locations (1)

Scientific Centre of Urology named after B.U Dzharbusynov 2, Basenov street,; 🇰🇿 Almaty, Kazakhstan