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)

PHASE3CompletedINTERVENTIONAL
Enrollment

598

Participants

Timeline

Start Date

March 4, 2014

Primary Completion Date

March 6, 2016

Study Completion Date

April 18, 2016

Conditions
Bacterial Infections
Interventions
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

Trial Locations (55)

116

Taipei

333

Taoyuan District

710

Tainan City

807

Kaohsiung City

10002

Taipei

40447

Taichung

81362

Kaohsiung City

89109

Las Vegas

91911

Chula Vista

91942

La Mesa

92056

Oceanside

100034

Beijing

100044

Beijing

100050

Beijing

100191

Beijing

100730

Beijing

110001

Shenyang

110016

Shenyang

116027

Dalian

130021

Changchun

200003

Shanghai

200025

Shanghai

200062

Shanghai

200092

Shanghai

201406

Shanghai

201700

Shanghai

210029

Nanjing

215006

Suzhou

241001

Wuhu

250012

Jinan

300052

Tianjin

300121

Tianjin

310003

Hangzhou

310009

Hangzhou

310014

Hangzhou

310016

Hangzhou

350025

Fuzhou

400042

Chongqing

410005

Changsha

410013

Changsha

410015

Changsha

430030

Wuhan

510120

Guangzhou

510180

Guangzhou

610041

Chengdu

650032

Kunming

710038

Xi'an

710061

Xi'an

830054

Ürümqi

07666

Teaneck

Unknown

Nanjing

Wuxi

City of Taguig

Quezon City

030001

Taiyuan

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Bayer

INDUSTRY