Fecal Microbiota Transplantation in Patients With Multiple Drug Resistant Klebsiella Pneumoniae Pneumonia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of days MDR-KP turns negative
研究概览
简要总结
Multidrug-resistant Klebsiella pneumoniae (MDR-KP) infections account for 10% of all nosocomial infections, and even with effective antibiotics, the mortality rate is as high as 50%. Intestinal bacteria transplantation can not only treat intestinal diseases, but also inhibit the colonization and proliferation of drug-resistant bacteria. This study explored the therapeutic value of fecal microbiota transplantation in patients with MDR-KP pneumonia.
详细描述
Intervention study (controlled clinical study) : patients with multidrug-resistant Klebsiella pneumoniae pneumonia were randomly assigned to the experimental group (conventional antibiotic treatment + fecal microbiota transplantation) and the control group (conventional antibiotic treatment); The clinical symptoms, inflammatory indexes, immune indexes, intestinal microecology, respiratory microecology and antibiotic resistance gene changes were compared between the two groups.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-75;
- •Meet the diagnostic criteria for community-acquired pneumonia or hospital-acquired pneumonia;
- •The etiological results of sputum or alveolar lavage fluid suggested MDR-KP infection;
- •The patient or his family members voluntarily participated, collected alveolar lavage fluid and stool samples, agreed to perform FMT treatment, and signed the informed consent.
排除标准
- •Subjects with persistent bronchial asthma, severe pulmonary dysfunction, or inability to tolerate bronchoscopy;
- •Patients with severe damage of intestinal barrier such as sepsis and digestive tract perforation due to various reasons;
- •Those currently diagnosed with explosive colitis or toxic megacolon have gastroesophageal reflux disease or peptic ulcer; Subjects taking probiotics within 6 months;
- •Enteral nutrition patients who could not tolerate 50% of heat calorie requirements due to severe diarrhea, significant fibrous intestinal stenosis, severe gastrointestinal bleeding, high-flow intestinal fistula and other reasons.
- •Patients with obvious bleeding tendency, severe pulmonary hypertension, superior vena cava obstruction, and aortic aneurysm rupture risk;
- •Patients with malignant hypertension, recent myocardial infarction (≤6 months), severe arrhythmia, and cardiac insufficiency;
- •suffering from malignant tumor diseases, congenital or acquired immune deficiency diseases, other systemic inflammatory response diseases;
- •Those who have recently been treated with high-risk immunosuppressive/cytotoxic drugs, such as rituximab, doxorubicin, or steroid hormones (20mg/d ponisone or higher) for more than 4 weeks;
- •Severe immunosuppression: adult neutrophils <1 500/mm3, child neutrophils <1 000/mm3;
- •Pregnancy or lactation;
- •There is a mental disability or active mental illness that prevents informed consent;
- •Conditions deemed unsuitable for study inclusion by other clinicians.
结局指标
主要结局
Number of days MDR-KP turns negative
时间窗: one month
The number of days that multidrug-resistant Klebsiella pneumoniae turned negative after treatment
Length of hospital stay
时间窗: one month
Total length of stay from admission to discharge or death
mortality rate
时间窗: one month
The ratio of death cases to the total number of patients
次要结局
- The Incidence of fever(one month)
- The incidence of cough(one month)
- The incidence of phlegm(one month)
- The incidence of chest pain assessed by VAS(one month)
研究者
luxia Kong
physician
Wuhan Central Hospital