Effect of Bacterial Lysates on Respiratory Tract Microecology in Patients With Mechanical Ventilation and Evaluation of the Efficacy of Prevention and Treatment of Ventilator-associated Pneumonia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- VAP incidence
研究概览
简要总结
The purpose of this study is to assess the effect of bacterial lysates on respiratory tract microecology in patients with mechanical ventilation and the efficacy of prevention and treatment of ventilator associated pneumonia.
详细描述
After being informed about the study and potential risks, all patients giving written informed consent will undergo a one-week screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be randomized in a double-blind manner in a 1:1 ratio to Bacterial Lysates( 14mg, once a day) or placebo(once a day).
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted to ICU for mechanical ventilation
- •The expected mechanical ventilation time is more than 72h
- •Sign the informed consent form when conscious and voluntary, and complete the questionnaire survey and follow-up as required; If it is unable to sign the informed consent form and complete the questionnaire survey and follow-up, the legal representative or guardian can act on behalf of it.
排除标准
- •Ventilator associated pneumonia is known and confirmed
- •Pregnant or lactating female
- •Allergic to the active ingredients of bacterial lysates or any excipients listed in the ingredients
- •Patients with autoimmune diseases
- •Patients with acute intestinal infection
- •Patients participating in other clinical studies at the same time
- •Patients considered unsuitable by other researchers to participate in this study
研究组 & 干预措施
Bacterial Lysate group
Oral / gastric administration of bacterial lysate once a day on an empty stomach, 14.0mg each time for at least 5 days
干预措施: Bacterial Lysates (Drug)
Control group
Oral / gastric administration of normal saline once a day, 14.0ml each time
干预措施: normal saline (Other)
结局指标
主要结局
VAP incidence
时间窗: 2 weeks
The incidence rate of ventilator associated pneumonia
次要结局
- Assessment of human immune status(one week)
- drug resistant bacteria Incidence(one week)
- Composition of respiratory bacteria(one week)
- survival rate(28 days)
研究者
Sheng Wang MD PhD
Director
Shanghai 10th People's Hospital