Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2026-02-10 @ 7:02 PM
Study NCT ID:
NCT02302092
Status:
TERMINATED
Last Update Posted:
2017-10-27
First Post:
2014-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Efficacy and Safety of Flomoxef Versus Cefepime in the Treatment of Participants With Urinary Tract Infections
Sponsor:
Takeda
Organization:
Study Overview
Official Title:
A Phase 3, Randomized, Double-blind, Multicenter Study Comparing the Efficacy and Safety of Intravenous Infusions of Flomoxef Versus Intravenous Infusions of Cefepime in the Treatment of Subjects With Complicated Urinary Tract Infections Including Pyelonephritis
Status:
TERMINATED
Status Verified Date:
2017-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was prematurely terminated due to administrative and strategic reasons
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FLORUS
Brief Summary:
The purpose of this study is to compare the effectiveness of antibiotic flomoxef with cefepime for the treatment of complicated urinary tract infections (cUTIs) in Russian adults.
Detailed Description:
The drug being tested in this study is called Flomoxef. Flomoxef is being tested in people with a complicated urinary tract infection (cUTI) including a kidney infection. This study compares Flomoxef to Cefepime, another antibiotic.
The study enrolled 13 patients.
Participants are randomly assigned by a computer generated number to one of two treatment groups:
* Flomoxef - intravenous infusion 2g twice daily (every 12 hours); or
* Cefepime - intravenous infusion 1g twice daily (every 12 hours).
This multi-center trial is conducted at 4 sites in the Russian Federation. The overall time to participate in this study is 30+/-3 days. Participants make six visits to the clinic.
Study was prematurely terminated due to administrative and strategic reasons.
The study enrolled 13 patients.
Participants are randomly assigned by a computer generated number to one of two treatment groups:
* Flomoxef - intravenous infusion 2g twice daily (every 12 hours); or
* Cefepime - intravenous infusion 1g twice daily (every 12 hours).
This multi-center trial is conducted at 4 sites in the Russian Federation. The overall time to participate in this study is 30+/-3 days. Participants make six visits to the clinic.
Study was prematurely terminated due to administrative and strategic reasons.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U1111-1154-2448 | REGISTRY | WHO | View |