Multi Center Clinical Research and Evaluation of Melting Technology for Rapid Detection of Drug Resistant Tuberculosis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 3,100
- 主要终点
- Comparison of diagnostic efficacy
研究概览
简要总结
Background:
Drug resistant tuberculosis is a serious public health problem that threatens the health of human life and the development of society and economy. At present, the diagnosis of drug-resistant tuberculosis mainly depends on traditional drug susceptibility test. But it is limited in Mycobacterium tuberculosis slow growth speed, traditional solid drug sensitivity test usually need to 3 months to results, delay the development of drug resistance in patients with effective treatment. Probe melting curves resistance detection technology is the recent emergence of a new molecular biology and drug resistant tuberculosis detection technology, probe melting curves with different fluorescent labeled probe coverage detection specific to M.tuberculosis drug resistance determining region, through changes in the melting point of the probe hybridization, acquire mutation information of detection region, shorten detection time and detect nonuniform resistance.
In this study, by selecting a nationally representative in different levels of hospitals jointly launched multi center, large sample clinical assessment, completed the comprehensive evaluation of sensitivity, specificity and health economics of drug resistant pulmonary tuberculosis, especially resistance to multidrug and extensively drug-resistant TB patients detection,in order to evaluate the rapid, accurate and economic and appropriate technology of drug resistance pulmonary tuberculosis detection.
In order to accomplish the overall goal of the project, in the framework of the overall design, according to the principles of the core tasks are divided into four sub topics, namely:
Sub topic 1 of the core mission is included in 3100 cases of smear positive pulmonary TB suspicious symptoms, from which selected more than 1000 cases of drug-resistant pulmonary tuberculosis patients, using MGIT liquid culture and drug sensitivity test as the gold standard,evaluate the sensitivity and specificity of probe melting curves in detction of resistance of four kinds of anti tuberculosis drug to Mycobacterium tuberculosis; Sub topic 2 core task is including at least 500 cases of culture positive pulmonary tuberculosis patients and treatment follow-up, using MGIT liquid culture and drug sensitivity test as the gold standard, evaluate the application value of probe melting curves for monitoring spectrum changes of drug resistance of Mycobacterium tuberculosis during pulmonary tuberculosis treatment.
The core mission of sub topic 3 is to project implementation of hospital as the research site,acquire the cost-effect evaluation and analysis by comparing probe melting technology with Mycobacterium tuberculosis MGIT liquid culture, and drug sensitivity test with xpert MTB/RIF technology.
详细描述
Sub topic 1:Probe melting curve method for the analysis of drug resistance detection technology for detection of Mycobacterium tuberculosis resistance performance analysis.
Research methods: multi center clinical study. Research object: sputum acid fast staining microscopy positive of pulmonary tuberculosis with suspicious symptoms.
Technical principle and operation method: see attachment.
Entry criteria:
- during the study of all smear positive pulmonary tuberculosis with suspicious symptoms; 2) can provide 3-4ml sputum samples three times in 2 days; 3) informed consent. Exclusion criteria: the quality of sputum specimen is not qualified (sputum sample is less than 3ml or saliva sputum).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •During the study of all smear positive pulmonary tuberculosis with suspicious symptoms
- •Can provide 3-4ml sputum samples three times in 2 days
- •Informed consent
排除标准
- •The quality of the sputum sample is not qualified (the sputum sample is less than 3ml or saliva sputum)
结局指标
主要结局
Comparison of diagnostic efficacy
时间窗: from January,2015 to December,2018
Using Xpert-MTB/RIF as control technology, the diagnostic efficacy of two kinds of drug resistance detection technology was compared.
Evaluation of the application value of probe melting curve technology
时间窗: up to 3.5 years
For the first time in China to carry out drug-resistant TB rapid detection technology appllied in the follow-up, improve the resistance detection technology to monitor the change of TB drug resistance spectrum in the treatment of pulmonary tuberculosis.Selecting patients with MGIT liquid culture positive pulmonary tuberculosis(selected from sub topic1) were included in the study，at least 500 patients were included in the study.Observe the outcomes and the change of drug resistance spectrum.drug-resistant TB rapid detection technology applied in the follow-up of patients with pulmonary TB by monitoring TB drug resistance spectrum change,provides the basis for the resistant phenotype and genotype identification and diagnosis of nonuniform resistance.Data statistics and analysis:95% confidence intervals, chi square test and Kappa test were calculated respectively.
analyze the cost-effect assessment of probe melting curve technology and other two kinds of detection methods
时间窗: up to 3.5 years
Complete the cost-effectiveness assessment analysis of the probe melting curve technology compared with Mycobacterium tuberculosis MGIT liquid culture and drug sensitivity test,and xpert MTB / RIF technology. Methods:Using cost analysis and acceptability questionnaire.Each of the implementation of the hospital, collecting the basic data and input the costs into the software,using opportunity cost method.
the sensitivity and specificity of probe melting curves technology
时间窗: up to 3.5 years
assess the sensitivity and specificity of probe melting curves for four kinds of anti tuberculosis drug resistance to Mycobacterium tuberculosis.
次要结局
未报告次要终点
研究者
Yanming Li
chief physician
Beijing Hospital