NCT03160807

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

An Open Label Non Placebo Study to Evaluate Efficacy and Safety of Levofloxacin as an Empirical Therapy in Patients With Complicated Urinary Tract Infections

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 214 (estimated)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: All
• Age: 19 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urinary Tract Infection

Interventions

Type	Name	Description
DRUG	Levofloxacin	Levolet 500 mg OD for 5 days
DRUG	Levofloxacin	Levolet 500 OD for 10 days

Timeline

• Start date: 2017-04-15
• Primary completion: 2018-03-01
• Completion: 2018-03-01
• First posted: 2017-05-19
• Last updated: 2017-05-19

Locations

1 site across 1 country: Kazakhstan