NCT07327619招募中3 期
A Multicenter, Randomized, Double-blind, Active-Controlled, Parallel, Phase Ⅲ Study to Evaluate the Efficacy and Safety of Meropenem and Pralurbactam for Injection Compared to Ceftazidime and Avibactam Sodium for Injection in Subjects With Hospital-acquired and Ventilator-associated Bacterial Pneumonia
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 420
- 试验地点
- 1
- 主要终点
- Proportion of Participants Who Died Due to Any Cause Description: Due to Day 14，Proportion of Participants Who Died Due to Any Cause in mITT
研究概览
简要总结
This study is to evaluate the efficacy and safety of Meropenem and Pralurbactam for Injection in Subjects with HABP/VABP. The primary objective is to demonstrate non-inferiority of Meropenem and Pralurbactam to Ceftazidime and Avibactam Sodium for Injection. This study is a randomized, double-blind, active-controlled study. The total duration of the study will be approximately 32 days including screening and follow-up.
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
- •1. Male or female participants ≥18 and ≤80 years of age
- •2. have a diagnosis of HAP/VAP.
- •3. have systemic signs and respiratory signs or symptoms of HAP/VAP.
- •4. New or worsening infiltrate on chest X-ray/CT obtained within 48 hours prior to screening.
- •5. The estimated survival time is at lest 28 days.
排除标准
- •1. Diagnosed or suspected CAP, Atypical pneumonias, Viral pneumonia or Chemical pneumonia.
- •2. The total duration of antibiotic exposure for antibiotics whose administration begins in the 72 hours is longer than 24 hours.
- •3. Acute Physiology and Chronic Health Evaluation (APACHE) II score >
- •4. Allergic to any carbapenem, cephalosporin, penicillin, metronidazole disodium phosphate, other beta-lactam drugs or other beta-lactamase inhibitors and their auxiliary materials.
- •5. Those who have a history of drug abuse or drug abuse within 6 months before screening.
- •6. 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
Experimental
干预措施: Meropenem and Pralurbactam (Drug)
Ceftazidime-avibactam
Active Comparator
干预措施: Ceftazidime-avibactam (Drug)
结局指标
主要结局
Proportion of Participants Who Died Due to Any Cause Description: Due to Day 14，Proportion of Participants Who Died Due to Any Cause in mITT
时间窗: Day 14
次要结局
未报告次要终点
研究者
研究点 (1)
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