NCT02302092

An Efficacy and Safety of Flomoxef Versus Cefepime in the Treatment of Participants With Urinary Tract Infections

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urinary Tract Infection

Interventions

Type	Name	Description
DRUG	Flomoxef	Flomoxef intravenous infusion
DRUG	Cefepime	Cefepime intravenous infusion

Timeline

• Start date: 2015-12-01
• Primary completion: 2016-02-02
• Completion: 2016-12-15
• First posted: 2014-11-26
• Last updated: 2017-10-27
• Results posted: 2017-10-27

Locations

5 sites across 1 country: Russia