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)
Completed · Phase 3 · Has a placebo group
Conditions studied: Bacterial Infections
In brief
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.
Key facts
- Study ID
- NCT02066402
- Run by
- Bayer
- People needed
- 598
- Starts
- 2014-03-04
- Expected to finish
- 2016-04-18
- Last updated by the study team
- 2017-06-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Study site — La Mesa, California, United States
- Study site — Oceanside, California, United States
- Study site — Las Vegas, Nevada, United States
- Study site — Teaneck, New Jersey, United States
- Study site — Wuhu, Anhui, China
- Study site — Fuzhou, Fujian, China
- Study site — Guangzhou, Guangdong, China
- Study site — Guangzhou, Guangdong, China
- Study site — Wuhan, Hubei, China
- Study site — Changsha, Hunan, China
- Study site — Changsha, Hunan, China
- Study site — Changsha, Hunan, China
- Study site — Nanjing, Jiangsu, China
- Study site — Nanjing, Jiangsu, China
- Study site — Suzhou, Jiangsu, China
- Study site — Wuxi, Jiangsu, China
- Study site — Changchun, Jilin, China
- Study site — Dalian, Liaoning, China
- Study site — Shenyang, Liaoning, China
- Study site — Shenyang, Liaoning, China
- Study site — Xi'an, Shaanxi, China
- Study site — Xi'an, Shaanxi, China
- Study site — Jinan, Shandong, China
- Study site — Taiyuan, Shanxi, China
- Study site — Chula Vista, California, United States
Full record on ClinicalTrials.gov
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