A Prospective, Randomized, Open-label, Active-controlled, Multicenter Study to Evaluate the Efficacy and Safety of BAY 1192631 in Japanese Patients With MRSA Infections (Skin and Soft Tissue Infection [SSTI] and SSTI-related Bacteremia)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 125
- 主要终点
- Clinical Response at Test of Cure (TOC)
研究概览
简要总结
The aim of this study is to see the efficacy and safety of BAY1192631 in Japanese patients with methicillin-resistant staphylococcus aureus (MRSA) (skin and soft tissue infections (SSTI) and SSTI-related bacteremia).
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
- None
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
- 未提供
排除标准
- •Having received any systemic antibacterial potentially effective against MRSA for >/=24 hours within 3 days prior to the first infusion of a study drug, or having received/expected to receive the medication within 24 hours prior to the first infusion, unless antibacterial therapy for >/=72 hours proves to be ineffective on or lack appropriate potency (resistant) to MRSA.
- •Moribund clinical condition such as death likely within the first 3 days of a study drug treatment
- •History of significant allergy or intolerance to linezolid or BAY1192631
- •Known or suspected human immunodeficiency virus (HIV) infection with a CD4+ T-cell count < 200/μL
- •Chronic treatment with immunosuppressive drugs
- •Active tuberculosis or non-tuberculous mycobacteriosis which need medical treatments
- •Current or anticipated neutropenia with neutrophil count < 1,000/ mm^3
- •Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) >/= 8 times the upper limit of reference range OR moderate to severe hepatic disease with Child Pugh score >/=10.
研究组 & 干预措施
Tedizolid Phosphate (Sivextro, BAY1192631)
Participants received 200 mg BAY1192631 solution or tablet once daily (intravenous (I.V.) or oral (PO))
干预措施: Tedizolid Phosphate (Sivextro, BAY1192631) (Drug)
Linezolid
Participants received 600 mg Linezolid solution or tablet twice daily, every 12 ± 3 hours (intravenous (I.V.) or oral (PO))
干预措施: Linezolid (Drug)
结局指标
主要结局
Clinical Response at Test of Cure (TOC)
时间窗: 7-14 days after the end of treatment (EOT) for skin and soft tissue infections (SSTI) and 4-6 weeks after EOT for bacteremia
Clinical response was evaluated by the masked investigator as clinical cure, clinical failure and indeterminate on the basis of the clinical symptoms/findings, vital sign and laboratory data from screening period to each evaluation point. Measurements for the assessment of clinical response included body temperature, pulse/heart rate, respiration rate, and white blood cell or band cell count.
Microbiological Response at Test of Cure (TOC)
时间窗: 7-14 days after the end of treatment (EOT) for skin and soft tissue infections (SSTI) and 4-6 weeks after EOT for bacteremia
Microbiological response was assessed in accordance with the Guidance for the method of microbiological assessment by Japanese Chemotherapy Society.
次要结局
- Clinical Response at End of Treatment Visit (EOT)(7-14 days for skin and soft tissue infections (SSTI) or 7-21 days for bacteremia from the study drug administration)
- Microbiological Response at End of Treatment (EOT)(7-14 days for skin and soft tissue infections (SSTI) or 7-21 days for bacteremia from the study drug administration)
- Reduction Ratio of the Lesion Size From the Screening Visit to Day 3 to Day 4 Visit (Only Skin and Soft Tissue Infection [SSTI])(Baseline and Day 3/4, Day 5/13, EOT, TOC)
- Change of the Lesion Size From the Screening Visit by Visit (Only Skin and Soft Tissue Infection [SSTI])(Multiple time points up to 7-14 days after the end of treatment)