A Phase 3, Multicenter, Randomized, Open-label, Active-controlled, Parallel-design Clinical Study to Evaluate the Efficacy and Safety of Meropenem and Pralubactam for Injection in the Treatment of Carbapenem-Resistant Enterobacteriaceae Infections
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Proportion of Participants With a Response of Overall Success(clinical response and microbiological response)[Complicated Urinary Tract Infection (cUTI)]
研究概览
简要总结
The study will evaluate the efficacy and safety of Meropenem and Pralurbactam versus Best Available Therapy in the treatment of Carbapenem-Resistant Enterobacteriaceae Infections. Infections evaluated in the study will be hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), complicated intra-abdominal infection (cIAI), complicated urinary tract infection (cUTI), and Bloodstream Infection (BSI).
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized male or female≥18 and ≤80 years of age，
- •Participant must have a diagnosis of an infection (HABP/VABP, cUTI, cIAI, BSI) due to confirmed Carbapenem-Resistant Enterobacteriaceae infection, requiring administration of IV antibacterial therapy
- •Participant who had received appropriate prior empiric antibacterial therapy for a carbapenem-resistant pathogen must meet at least 1 of the following criteria: no or no more than 24h; worsening of objective symptoms or signs after at least 48 hours of antibacterial therapy; no change of objective symptoms or signs after at least 72 hours of antibacterial therapy
- •The estimated survival time is more than 28 days
- •Understand and abide by the research procedures and methods, voluntarily participate in this research, and sign an informed consent form
排除标准
- •Participants who need more than 3 systemic antibiotics as part of best available treatment (BAT)
- •Participant is expected to require more than 21 days of treatment
- •Acute Physiology and Chronic Health Evaluation (APACHE) II score >30 using the most recent available data
- •Other medical or psychiatric condition may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- •Those who participated in other clinical trials within 28 days before randomization and used any test drugs or medical devices
研究组 & 干预措施
Meropenem and Pralurbactam
Meropenem and Pralurbactam (180min infusion)
干预措施: Meropenem and Pralurbactam (Drug)
Best Available Therapy
Subjects will receive Best Available Therapy (IV antibiotics)
干预措施: Best Available Therapy (e.g., colistin, meropenem, tegecycline, amikacinceftezidime-avibatam) (Drug)
结局指标
主要结局
Proportion of Participants With a Response of Overall Success(clinical response and microbiological response)[Complicated Urinary Tract Infection (cUTI)]
时间窗: at Test of Cure (TOC) visit (Day 12-23)
Proportion of Participants Who Died Due to Any Cause[Hospital-acquired Bacterial Pneumonia (HABP), Ventilator-associated Bacterial Pneumonia (VABP) and Bloodstream Infection(BSI) Subjects]
时间窗: Day 28
Proportion of Participants With a clinical response [Complicated Intra-abdominal Infection (cIAI) Subjects]
时间窗: at Test of Cure (TOC) visit (Day 10-23
次要结局
未报告次要终点