A Phase 3, Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Contezolid Acefosamil and Contezolid Compared to Linezolid Administered Intravenously and Orally to Adults With Moderate or Severe Diabetic Foot Infections (DFI)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 865
- 试验地点
- 14
- 主要终点
- Clinical response calculated with percentage of subjects with resolution of DFI signs and symptoms and requiring no further therapy as assessed by Investigators
研究概览
简要总结
This is a Phase 3, multicenter, randomized, double-blind, safety and efficacy study of contezolid acefosamil (IV)/contezolid (PO) compared with linezolid (IV and PO) administered for a total of 14 to 28 days in adult subjects with moderate or severe DFI.
详细描述
Approximately 865 subjects (519 contezolid acefosamil/contezolid: 346 linezolid) will be enrolled with moderate or severe DFI that are confirmed or suspected to be due to a Gram-positive bacterial pathogen (MITT analysis set).
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
- Double (Participant, Investigator)
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
- •Have diabetes mellitus (type 1 or 2) per the American Diabetes Association criteria
- •Have a foot infection that started at or below the malleolus and does not extend above the knee
- •Foot infection that meets the IWGDF DFI criteria for classification 3 (moderate infection) or 4 (severe infection)
- •Foot infection had acute onset or worsening of signs and symptoms within the past 14 days
排除标准
- •Previous DFI known or suspected to be caused by Gram-positive pathogens that are resistant to oxazolidinone antibiotics
- •DFI with presumptive evidence or suspicion of osteomyelitis
- •Necrotizing fasciitis, crepitant cellulitis, wet gangrene, gas gangrene, ecthyma gangrenosum, septic arthritis, or severely impaired arterial supply to any portion of the affected foot which may need revascularization before the end of the study
- •Evidence of significant hepatic, renal, hematologic, or immunologic disease
- •Females who are pregnant or breastfeeding
- •Prior receipt of any formulation of contezolid acefosamil or contezolid
- •Inability to cooperate fully with the requirements of the study protocol, including the schedule of events, or likely to be noncompliant with any study requirements, or the Investigator determines that the subject should not participate in the study
研究组 & 干预措施
contezolid acefosamil/contezolid
干预措施: contezolid acefosamil (IV)/contezolid (PO) (Drug)
linezolid
干预措施: Linezolid (IV and PO) (Drug)
结局指标
主要结局
Clinical response calculated with percentage of subjects with resolution of DFI signs and symptoms and requiring no further therapy as assessed by Investigators
时间窗: Day 35
The primary objective is to evaluate the Investigator's assessment of clinical response at the D35 visit in subjects receiving contezolid acefosamil/contezolid compared to subjects receiving linezolid in the MITT analysis
Clinical laboratory assessment - complete blood count
时间窗: 28-35 days after End-of-Therapy (EOT)
Will be evaluated under safety of contezolid acefosamil (IV)/contezolid (PO) compared with linezolid (IV and PO)
Vital signs - heart rate
时间窗: 28-35 days after End-of-Therapy (EOT)
Will be evaluated under safety of contezolid acefosamil (IV)/contezolid (PO) compared with linezolid (IV and PO)
Adverse events - symptoms reported by subjects
时间窗: 28-35 days after End-of-Therapy (EOT)
Evaluate safety of contezolid acefosamil (IV)/contezolid (PO) compared with linezolid (IV and PO)
次要结局
- Clinical response calculated with percentage of subjects with resolution of DFI signs and symptoms and requiring no further therapy as assessed by Investigators(Day 10, 28-35 days after EOT)