Multi-drug Resistant Gram-negative Bacilli-surveillance and Clinical Feature in China
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
Objective
- To evaluate the impact of MDR pathogen on prognosis and therapy cost;
- To compare the efficacy of different antibiotics in treatment of infection caused by MDR pathogens;
- To evaluate the risk factors of MDR pathogens infection;
- To evaluate the distribution and characteristics of MDR pathogens;
- To investigate the proportion of MDR isolates to construct systematic database.
详细描述
- Background:
In recent years, the incidence of infection caused by multi-drug resistant (MDR) pathogen keeps increasing. The increase of MDR bacterial is a serious challenge for empirical therapy. Common empirical antibiotic may not cover MDR pathogen and is inappropriate for patients with infection caused by MDR pathogens, which finally increases mortality. A number of studies have demonstrated MDR pathogens are related to excess mortality, longer hospital stays and more treatment cost. Compared to infection caused by non-MDR pathogens, infection caused by MDR pathogens possesses higher mortality by 10% to 15%, longer ICU stays by 6 -10 days, and less appropriate empirical antibiotics by 50%. In addition, studies have shown that the treatment of infection caused by MDR pathogens is more expensive by $10,000-$50,000 than that by sensitive pathogens. Monitoring of MDR pathogens may find epidemiological trends, discover new MDR bacteria, evaluate risk factors and assess the effectiveness of interventions. Data of MDR pathogens has been available in Europe and the United States, however, is absent in China. By now, the features of bacterial resistance in different regions, hospitals, or in certain patients with exposure to antibiotics, still keep uncertainty.
The current study is to enroll continuous MDR isolates and clinical data of the patients from which the pathogens were isolated. The data may clarify the distribution and characteristics of MDR pathogens in China, as well as clinical outcome of infection caused by MDR pathogens, which is essential for management and treatment of infection caused by MDR pathogens. 2. Study center: 10 3. Strains MDR gram-negative bacilli isolated from lower respiratory tract, pleural effusion or blood will be reported to clinician. Confirmation that the isolate is 'real' pathogen of a certain infection, not colonization or pollution, is needed. Microbiologic data will be collected, such as result of susceptibility test.
Inclusion criteria:
- Gram-negative bacillus.
- Resistant to more than 3 kinds of antibacterial agents.
Exclusion criteria:
- Repetitive organism isolated from the same center in one patient.
- Judged as colonization or pollution by clinician.
- Enrolled into other trial, and the data is not available for the current study.
- Microbiologic investigators collect data:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Gram-negative bacillus.
- •Resistant to more than 3 kinds of antibacterial agents.
排除标准
- •Repetitive organism isolated from the same center in one patient.
- •Judged as colonization or pollution by clinician.
- •Enrolled into other trial, and the data is not available for the current study.
结局指标
主要结局
Mortality
时间窗: Jun 2015
Mortality comparizon between MDR or non-MDR infection
次要结局
- Therapy cost(Jun 2015)
研究者
Prof Xie Canmao
Director, Respiratory Department
Sun Yat-sen University