Ignite Creation Date:
2024-05-06 @ 10:07 AM
Last Modification Date:
2024-10-26 @ 12:24 PM
Study NCT ID:
NCT03160807
Status:
UNKNOWN
Last Update Posted:
2017-05-19
First Post:
2016-06-28
Brief Title:
Levofloxacin as an Empirical Therapy in Patients With Complicated Urinary Tract Infections
Sponsor:
Dr Reddys Laboratories Limited
Organization:
Dr Reddys Laboratories Limited
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2017-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Levolet-KZ16
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None