Phase 2, Double-Blind, Randomized, Multicenter, Parallel, Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TNP-2092 to Treat Acute Bacterial Skin and Skin Structure Infection in Adults
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Early Clinical Response at the Early Assessment Visit in the Modified Intent-to-Treat (mITT) Population
研究概览
简要总结
The purpose of this study is to evaluate safety, tolerability, pharmacokinetic characteristics and efficacy of TNP-2092 in adults with ABSSSI suspected or confirmed to be caused by gram-positive pathogens.
详细描述
This Phase 2, double-blind, randomized, multicenter, parallel, controlled study is conducted to evaluate safety, tolerability, pharmacokinetics and efficacy of TNP-2092, and vancomycin in adults with ABSSSI suspected or confirmed to be caused by gram-positive pathogens. The duration of the treatment period is a minimum of 7 days and a maximum of 14 days.
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
- •Subjects may be included in the study if they meet all of the following inclusion criteria:
- •Males or females, 18 years of age or older;
- •ABSSSI suspected or confirmed to be caused by gram-positive pathogens, including:
- •Cellulitis/erysipelas;
- •Wound infection;
- •Major cutaneous abscess;
- •Lesion with a minimum surface area of 75 cm2;
- •Capable of giving signed informed consent.
排除标准
- •Subjects will be excluded from the study if any of the following exclusion criteria apply prior to randomization:
- •History or hypersensitivity or intolerability to any fluoroquinolone, rifamycin or glycopeptide classes;
- •ABSSSI suspected or confirmed to be caused by pathogens that are resistant to the glycopeptide class;
- •Prior administration of systemic antibacterial therapy within 96 hours before randomization;
- •ABSSSI with suspected or confirmed infection caused by gram-negative or anaerobic organisms;
- •ABSSSI with suspected or confirmed infection caused by fungal, mycobacterial, parasitic, or viral pathogens;
- •Evidence of significant hepatic, hematologic, or immunologic disease;
- •History or evidence of severe renal disease.
研究组 & 干预措施
TNP-2092
TNP-2092 300 mg intravenous every 12 hours
干预措施: TNP-2092 (Drug)
Vancomycin
vancomycin 1 g intravenous every 12 hours
干预措施: Vancomycin (Drug)
结局指标
主要结局
Early Clinical Response at the Early Assessment Visit in the Modified Intent-to-Treat (mITT) Population
时间窗: 48 to 72 hours after the first dose of study treatment
Early clinical response is defined as responder meeting two criteria: (1) patient had at least a 20% reduction of acute bacterial skin and skin structure infection (ABSSSI) primary lesion size compared to baseline measurements; (2) patient did not die of any cause within 72 hours of the first dose of study treatment. An indeterminate classification is used for a response that could not be adequately inferred because study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up, did not attend the EA clinic appointment), or if the early assessment visit is out of the 48 to 72 hours window after the intravenous study treatment starts.
Early Clinical Response at the Early Assessment Visit in the Micro-Intent-to-Treat (Micro-ITT) Population
时间窗: 48 to 72 hours after the first dose of study treatment
Early clinical response is defined as responder meeting two criteria: (1) patient had at least a 20% reduction of acute bacterial skin and skin structure infection (ABSSSI) primary lesion size compared to baseline measurements; (2) patient did not die of any cause within 72 hours of the first dose of study treatment. An indeterminate classification is used for a response that could not be adequately inferred because study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up, did not attend the EA clinic appointment), or if the early assessment visit is out of the 48 to 72 hours window after the intravenous study treatment starts.
Early Clinical Response at the Early Assessment (EA) Visit in the Intent-to-Treat (ITT) Population
时间窗: 48 to 72 hours after the first dose of study treatment
Early clinical response is defined as responder meeting two criteria: (1) patient had at least a 20% reduction of acute bacterial skin and skin structure infection (ABSSSI) primary lesion size compared to baseline measurements; (2) patient did not die of any cause within 72 hours of the first dose of study treatment. An indeterminate classification is used for a response that could not be adequately inferred because study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up, did not attend the EA clinic appointment), or if the early assessment visit is out of the 48 to 72 hours window after the intravenous study treatment starts.
次要结局
- Cmax After Last Infusion(57 to 60 minutes, 1.5 to 3 hours, 4 to 6 hours, 12 hours, after the last infusion)
- Cmax After First Infusion(57 to 60 minutes, 1.5 to 3 hours, 4 to 6 hours, 12 hours, after the first infusion)
- Investigator's Assessment of Clinical Response at the End of Treatment (EOT) Visit in the mITT Population(After a minimum of 7 days up to 14 days of study treatment)
- Investigator Assessment of Clinical Response at Post Treatment Evaluation (PTE) Visit in the mITT Population(7 to 14 days after the end of study treatment)
- Investigator Assessment of Clinical Response at Post Treatment Evaluation (PTE) Visit in the Micro-ITT Population(7 to 14 days after the end of study treatment)
- AUC0-12h After First Infusion(0 to 12 hours post-dose)
- AUC0-12h After Last Infusion(0 to 12 hours post-dose)
- Investigator's Assessment of Clinical Response at the End of Treatment (EOT) Visit in the Micro-ITT Population(After a minimum of 7 days up to 14 days of study treatment)