The Effectiveness and Safety Study of Eravacycline Combination Therapy for Multidrug-Resistant Acinetobacter Baumannii Pneumonia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Clinical Responded Rate
研究概览
简要总结
The goal of this observational study is to learn about the eravacycline combination therapy in multidrug-resistant acinetobacter gaumannii pneumonia. The main question is to evaluate the the effectiveness and safety.
Participants will be given Eravacycline and Polymyxin，or other antibiotcs that the Investigator considered suitable. During the clinical trial, participants will be monitored for blood drug concentrations and drug concentrations in the ELF (Epithelial Lining Fluid。Clinical efficacy rate and microbiological clearance rate will be assessed at the same time
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •≥18 years old;
- •Meets the diagnostic criteria for pneumonia specified by the Chinese Medical Association Respiratory Branch.
- •CRAB is identified or predominant pathogenic bacteria, and drug sensitivity test indicates that Eravacycline is sensitive to the strain;
- •Patients expected to receive Eravacycline for ≥4 days;
- •Has already signed the informed consent
排除标准
- •Pregnant or lactating;
- •Concurrent intracranial infection, urinary tract infection, or bloodstream infection;
- •Individuals in a moribund state;
- •The investigator believes there is any medical history, current condition, treatment, laboratory abnormalities, or other circumstances that may affect the trial results, interrupt the trial process (or the subject's inability to complete all trial requirements, operations, and visits), or increase the subject's risk with the experimental medication. Patients with terminal illnesses or evidence of immediately life-threatening diseases are excluded;
- •Patients with a history of allergic reactions to tetracyclines or any excipients in the investigational drug formulation
研究组 & 干预措施
Eravacyline combination
干预措施: Eravacycline Injection (Drug)
结局指标
主要结局
Clinical Responded Rate
时间窗: 28 days
Complete the treatment, and meet one of the following criteria to be considered clinical respond: 1. Patient's oxygenation index is stable or improved; 2. Patients with a SOFA score \<3 remain unchanged or decrease, and patients with a SOFA score ≥3 decrease by at least 30%; 3. Normal body temperature for more than 3 days; 4. Improvement in pulmonary imaging; 5. Infection indicators show a continuous downward trend for 3 consecutive day
次要结局
- "Incidence Rate of Adverse Event(28days)
- The microbiological clearance rate(within 14days)
- The all-cause mortality rate within 28 days(28 days)
研究者
Hui Zhang，PhD
Chief physician
Fujian Medical University Union Hospital