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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 598
- 主要终点
- Percentage of Participants With Early Clinical Response at 48-72 Hours After the First Infusion of Study Drug in the ITT Analysis Set.
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Tedizolid Phosphate (Sivextro, BAY119-2631)
Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo.
干预措施: Tedizolid (BAY119-2631) (Drug)
Tedizolid Phosphate (Sivextro, BAY119-2631)
Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo.
干预措施: Placebo Tedizolid (BAY119-2631) (Drug)
Tedizolid Phosphate (Sivextro, BAY119-2631)
Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo.
干预措施: Placebo Linezolid (Drug)
Linezolid
Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days.
干预措施: Placebo Tedizolid (BAY119-2631) (Drug)
Linezolid
Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days.
干预措施: Linezolid (Drug)
结局指标
主要结局
Percentage of Participants With Early Clinical Response at 48-72 Hours After the First Infusion of Study Drug in the ITT Analysis Set.
时间窗: Baseline and 48-72 hours visit
Early clinical response is defined as responder if there is \>=20% reduction in the area of erythema, edema, and/or induration (length × width) of the primary acute bacterial skin and skin structure infections (ABSSSI) lesion, compared with baseline at the 48-72 Hour visit.
次要结局
- Programmatically Defined Clinical Response at End of Therapy (EOT) Visit in the ITT Analysis Set(Baseline and EOT visit (Day 11))
- Programmatically Defined Clinical Response at End of Therapy (EOT) Visit in the Clinically Evaluable at EOT (CE-EOT) Analysis Set(Baseline and EOT visit (Day 11))
- Overall Investigator's Assessment of Clinical Success at Post Therapy Evaluation (PTE) Visit (7-14 Days After EOT Visit) in the ITT Analysis Set(Baseline and post-therapy evaluation visit (7-14 days after Day 11))
- Value of the Visual Analog Scale (VAS) Pain Scores at Each Time Point(Up to EOT visit (Day 11))
- Change From Baseline in the Visual Analog Scale (VAS) Pain Scores at Each Time Point(Up to EOT visit (Day 11))
- Value of the Faces Rating Scale (FRS) Pain Scores at Each Time Point(Up to EOT visit (Day 11))
- Change From Baseline in the Faces Rating Scale (FRS) Pain Scores at Each Time Point(Up to EOT visit (Day 11))
- Overall Investigator's Assessment of Clinical Success at Post Therapy Evaluation (PTE) Visit (7-14 Days After EOT Visit) in the Clinically Evaluable at Post Therapy Evaluation (CE-PTE) Analysis Set(Baseline and post-therapy evaluation visit (7-14 days after Day 11))
- Investigator's Assessment of Clinical Response at 48-72 Hours(Baseline and at 48-72 hours)
- Investigator's Assessment of Clinical Response at Day 7 Visit(Baseline and Day 7 visit)