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

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

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Locations
Status
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Locations

Investigative Site

Las Vegas, United States, 89109

Status
Completed
 
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Oceanside, United States, 92056

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Completed
 
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Teaneck, United States, 07666

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Completed
 
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La Mesa, United States, 91942

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Completed
 
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Chula Vista, United States, 91911

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Completed
 
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Chengdu, China, 610041

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Completed
 
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Beijing, China, 100191

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Completed
 
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Beijing, China, 100034

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Terminated
 
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Beijing, China, 100044

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Terminated
 
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Beijing, China, 100730

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Completed
 
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Dalian, China, 116027

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Completed
 
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Guangzhou, China, 510180

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Completed
 
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Guangzhou, China, 510120

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Completed
 
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Wuhan, China, 430030

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Completed
 
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Changsha, China, 410005

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Completed
 
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Nanjing, China, 210029

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Completed
 
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Changchun, China, 130021

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Completed
 
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Kunming, China, 650032

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Completed
 
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Nanjing, China

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Completed
 
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Jinan, China, 250012

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Terminated
 
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Shanghai, China, 200003

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Completed
 
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Shanghai, China, 200025

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Completed
 
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Shanghai, China, 200092

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Completed
 
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Shanghai, China, 200062

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Completed
 
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Beijing, China, 100050

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Completed
 
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Suzhou, China, 215006

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Completed
 
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Tianjin, China, 300121

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Completed
 
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Tianjin, China, 300052

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Completed
 
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Wuhu, China, 241001

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Completed
 
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Wuxi, China

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Completed
 
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Xi'an, China, 710061

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Completed
 
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Urumqi, China, 830054

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Completed
 
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Urumchi, China, 830054

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Completed
 
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Hangzhou, China, 310009

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Completed
 
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Hangzhou, China, 310003

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Terminated
 
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Hangzhou, China, 310014

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Completed
 
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Chongqing, China, 400042

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Terminated
 
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Fuzhou, China, 350025

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Completed
 
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Shenyang, China, 110016

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Completed
 
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Shenyang, China, 110001

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Terminated
 
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Changsha, China, 410013

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Completed
 
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Quezon City, Philippines

Status
Completed
 
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Taguig City, Philippines

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Completed
 
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Xi'an, China, 710038

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Completed
 
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Taipei, Taiwan, China, 10002

Status
Completed
 
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Taoyuan, Taiwan, China, 333

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Terminated
 
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Taichung, Taiwan, China, 40447

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Completed
 
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Tainan, Taiwan, China, 710

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Completed
 
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Kaohsiung, Taiwan, China, 81362

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Completed
 
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Kaohsiung, Taiwan, China, 807

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Completed
 
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Taipei, Taiwan, China, 116

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Completed
 
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Changsha, China, 410015

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Completed
 
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Hangzhou, China, 310016

Status
Completed
 
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Shanghai, China, 201700

Status
Completed
 
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Investigative Site

Taiyuan, China, 030001

Status
Completed
 
Locations

Investigative Site

Shanghai, China, 201406

Status
Completed
 

Trial Design