NCT02066402

Efficacy and Safety of Intravenous to Oral 6-Day Tedizolid Phosphate vs. Intravenous to Oral 10-Day Linezolid in Patients With Acute Bacterial Skin and Skin Structure Infection (ABSSSI)

A Phase 3 Randomized, Double-Blind, Multicenter Study Comparing the Efficacy and Safety of Intravenous to Oral 6-Day Tedizolid Phosphate and Intravenous to Oral 10-Day Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 598 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is aimed to evaluate the efficacy and safety between Tedizolid 200mg daily (intra venous) I.V. to oral for 6-day treatment compared with that of Linezolid 600mg twice daily I.V. to oral for 10-day treatment Acute Bacterial Skin and skin structure infection (ABSSSI).This is a double-blind, randomized, active control, 7-10days treatment for all subjects.

Detailed description

Number of participants with adverse evnets as a measure of safety and tolerability will be covered in Adverse Events section. ABSSSI Efficacy Safety Tedizolid Phosphate Linezolid

Conditions

• Bacterial Infections

Interventions

Type	Name	Description
DRUG	Tedizolid (BAY119-2631)	50 % of the participants will be randomized to this arm and will receive 200 mg Tedizolid once daily i.v to oral from 1-6 days
DRUG	Placebo Tedizolid (BAY119-2631)	50 % of the participants will be randomized to this arm and will receive 200 mg Placebo Tedizolid once daily i.v to oral from 7-10 days
DRUG	Linezolid	50 % of the participants will be randomized to this arm and will receive 600 mg Linezolid twice daily i.v. to oral from 1-10 days
DRUG	Placebo Linezolid	50 % of the participants will be randomized to this arm and will receive 600 mg Placebo Linezolid twice daily i.v. to oral from 1-10 days

Timeline

• Start date: 2014-03-04
• Primary completion: 2016-03-06
• Completion: 2016-04-18
• First posted: 2014-02-19
• Last updated: 2017-06-07
• Results posted: 2017-06-07

Locations

55 sites across 4 countries: United States, China, Philippines, Taiwan