Trial Condition(s):

Bacterial Infections

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)

Bayer Identifier:

16121

ClinicalTrials.gov Identifier:

NCT02066402

EudraCT Number:

Not Available

EU CT Number:

Not Available

Study Completed

Trial Purpose

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.

Inclusion Criteria
- Males or females >/=18 years old
 - Adequate venous access for a minimum of 2 I.V. doses of study drug
 -  Acute Bacterial Skin and skin structure infection (ABSSSI) meeting at least 1 of the clinical syndrome definitions listed below and requiring I.V. antibiotic therapy. Local symptoms must have started within 7 days before the Screening Visit
 --  Cellulitis/erysipelas
 --  Major cutaneous abscess
 -- Wound Infection
 - Suspected or documented gram-positive infection from baseline Gram stain or culture.
Exclusion Criteria
- Uncomplicated skin and skin structure infections such as furuncles, minor abscesses
 - Infections associated with, or in close proximity to, a prosthetic device
 - Severe sepsis or septic shock
 - Known bacteremia at time of screening
 -  ABSSSI due to or associated with any of the following: 
 -- Suspected or documented gram-negative pathogens in patients with cellulitis/erysipelas or major cutaneous abscess that require an antibiotic with specific gram-negative coverage. Patients with wound infections where gram-negative adjunctive therapy is warranted may be enrolled if they meet the other eligibility criteria
 -- Diabetic foot infections, gangrene, or perianal abscess
 -- Concomitant infection at another site not including a secondary ABSSSI lesion (eg, septic arthritis, endocarditis, osteomyelitis)
 --  Infected burns
 -- Decubitus or chronic skin ulcer, or ischemic ulcer due to peripheral vascular disease (arterial or venous)
 -- Any evolving necrotizing process (ie, necrotizing fasciitis)
 - Use of antibiotics as follows:
 -- Systemic antibiotic with gram-positive cocci activity for the treatment of any infection within 24 hours before the first infusion of study drug
 -- Patients who failed prior therapy for the primary infection site are also excluded from enrollment
 -- Topical antibiotic on the primary lesion within 24 hours before the first infusion of study drug except for antibiotic/antiseptic-coated dressing applied to the clean postsurgical wound
 - Administration of Linezolid within 30 days before the first infusion of the study drug
 - Recent history of opportunistic infections where the underlying cause of these infections is still active (eg, leukemia, transplant, acquired immunodeficiency syndrome [AIDS])
 - Previous exposure to Tedizolid Phosphate treatment

Trial Summary

Enrollment Goal
598
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
Yes
Products
Sivextro (Tedizolid phosphate, BAY119-2631)
Accepts Healthy Volunteers
No

Where to Participate

Loading...
Locations
Locations
Locations

Investigative Site

Las Vegas, United States, 89109

Locations

Investigative Site

Oceanside, United States, 92056

Locations

Investigative Site

Teaneck, United States, 07666

Locations

Investigative Site

La Mesa, United States, 91942

Locations

Investigative Site

Chula Vista, United States, 91911

Locations

Investigative Site

Chengdu, China, 610041

Locations

Investigative Site

Beijing, China, 100191

Locations

Investigative Site

Beijing, China, 100034

Locations

Investigative Site

Beijing, China, 100044

Locations

Investigative Site

Beijing, China, 100730

Locations

Investigative Site

Dalian, China, 116027

Locations

Investigative Site

Guangzhou, China, 510180

Locations

Investigative Site

Guangzhou, China, 510120

Locations

Investigative Site

Wuhan, China, 430030

Locations

Investigative Site

Changsha, China, 410005

Locations

Investigative Site

Nanjing, China, 210029

Locations

Investigative Site

Changchun, China, 130021

Locations

Investigative Site

Kunming, China, 650032

Locations

Investigative Site

Nanjing, China

Locations

Investigative Site

Jinan, China, 250012

Locations

Investigative Site

Shanghai, China, 200003

Locations

Investigative Site

Shanghai, China, 200025

Locations

Investigative Site

Shanghai, China, 200092

Locations

Investigative Site

Shanghai, China, 200062

Locations

Investigative Site

Beijing, China, 100050

Locations

Investigative Site

Suzhou, China, 215006

Locations

Investigative Site

Tianjin, China, 300121

Locations

Investigative Site

Tianjin, China, 300052

Locations

Investigative Site

Wuhu, China, 241001

Locations

Investigative Site

Wuxi, China

Locations

Investigative Site

Xi'an, China, 710061

Locations

Investigative Site

Urumqi, China, 830054

Locations

Investigative Site

Urumchi, China, 830054

Locations

Investigative Site

Hangzhou, China, 310009

Locations

Investigative Site

Hangzhou, China, 310003

Locations

Investigative Site

Hangzhou, China, 310014

Locations

Investigative Site

Chongqing, China, 400042

Locations

Investigative Site

Fuzhou, China, 350025

Locations

Investigative Site

Shenyang, China, 110016

Locations

Investigative Site

Shenyang, China, 110001

Locations

Investigative Site

Changsha, China, 410013

Locations

Investigative Site

Quezon City, Philippines

Locations

Investigative Site

Taguig City, Philippines

Locations

Investigative Site

Xi'an, China, 710038

Locations

Investigative Site

Taipei, Taiwan, China, 10002

Locations

Investigative Site

Taoyuan, Taiwan, China, 333

Locations

Investigative Site

Taichung, Taiwan, China, 40447

Locations

Investigative Site

Tainan, Taiwan, China, 710

Locations

Investigative Site

Kaohsiung, Taiwan, China, 81362

Locations

Investigative Site

Kaohsiung, Taiwan, China, 807

Locations

Investigative Site

Taipei, Taiwan, China, 116

Locations

Investigative Site

Changsha, China, 410015

Locations

Investigative Site

Hangzhou, China, 310016

Locations

Investigative Site

Shanghai, China, 201700

Locations

Investigative Site

Taiyuan, China, 030001

Locations

Investigative Site

Shanghai, China, 201406

Trial Design