An observational study in Tuberculosis, Pulmonary, sponsored by Beijing Hospital. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-05-18.
Sponsored by Beijing Hospital · Observational
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.
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:
(2) the clinical symptoms and signs: fever, night sweats, cough, sputum and sputum, weight loss, hemoptysis or sputum with blood, chest pain, dyspnea, fatigue, height, weight, pulmonary rales.
(3) chest imaging (chest X-ray or CT scan): the specific description of the lesion distribution and morphological characteristics and scoring.
(4) laboratory examination: erythrocyte sedimentation rate (ESR), blood routine test, blood biochemistry (AST, ALT, TP, ALB, BUN, Cr and Glu), C-reactive protein (CRP).
(5) microbiological examination of sputum, sputum acid fast staining microscopy, MGIT liquid culture and drug sensitivity detection, xpert MTB/RIF, probe melting curves technology.
95% confidence intervals, using statistical methods by chi square test and Kappa test.
sub topic 2:the follow up of diagnosis and treatment in application of Probe melting curve method of resistance detection in patients with pulmonary tuberculosis.
Research methods: multi center clinical study. Study subjects and sample size: MGIT liquid culture positive pulmonary tuberculosis patients in sub topic 1, to be included in at least 500 cases.
Entry criteria and exclusion criteria: the same as the research sub topic 1.
1 observation index:
classification of outcomes:
(f) diagnostic change: diagnosis of pulmonary tuberculosis in the treatment process.
2.quality control and acceptance: the same research sub topic 1. 3 data statistics and analysis: Probe melting curves,the molecular diagnostic technique in patients with pulmonary tuberculosis treatment with statistical methods is the application of diagnosis in the calculated two-sided 95% confidence interval, chi square test and kappa test.
sub topic 3:Probe melting curve technology for the cost-effect analysis in detection of drug-resistant Mycobacterium tuberculosis.
Methods: using the cost analysis method and the questionnaire. Research object: research project implementation hospital laboratory.
Data collection, statistics and analysis:
1 cost analysis
each of the implementation of the following basic data collection and data entry software.
(f) the above collection cost input software, as a basis for the implementation of the basic data of the hospital;
2 acceptance survey: the design of the questionnaire, the survey of 3 projects in the implementation of the hospital not less than 10 laboratory technicians. The questionnaire covers the convenience of other methods, the needs of the laboratory, the application prospects and other aspects of the content.
1,417 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.
This study's planned enrollment of 3,100 is above the median of 250 across 421 observational studies indexed under Tuberculosis.
Browse Tuberculosis studies →Beijing Hospital is the lead sponsor of 51 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
the population of suspected symptoms of tuberculosis with sputum smear microscopy positive
Exclusion Criteria:
MGIT: The bactec MGIT 960 system is non-radiometric. It uses MGIT media and patented sensors, making efficient use of advanced fluorometric technology, which permits highly accurate detection of O2 consumption without sharps. Automated quality control is performed continuously to ensure precise and reliable operation. Results are provided as positive/negative and numerical growth units.
xpert-MTB/RIF: The Xpert MTB/RIF assay is a nucleic acid amplification (NAA) test that uses a disposable cartridge with the GeneXpert Instrument System. A sputum sample is collected from the patient with suspected TB. The sputum is mixed with the reagent that is provided with the assay, and a cartridge containing this mixture is placed in the GeneXpert machine. All processing from this point on is fully automated.The test simultaneously detects Mycobacterium tuberculosis complex (MTBC) and resistance to rifampin (RIF) in less than 2 hours.
Probe-based fluorescence melting curve analysis (FMCA) is a powerful tool for mutation detection based on melting temperature generated by thermal denaturation of the probe-target hybrid, which performed for Mycobacterium tuberculosis's drug resistant monitor. The method was explored two dual-labeled, self-quenched probes, TaqMan and shared-stem molecular beacons, in their ability to conduct FMCA. Both probes could be directly used for FMCA and readily integrated with closed-tube amplicon hybridization under asymmetric PCR conditions. Improved flexibility of FMCA by using these probes was illustrated in three representative applications of FMCA: mutation scanning, mutation identification and mutation genotyping, all of which achieved improved color-multiplexing with easy probe design and versatile probe combination and all were validated with a large number of real clinical samples.
the sensitivity and specificity of probe melting curves technology
assess the sensitivity and specificity of probe melting curves for four kinds of anti tuberculosis drug resistance to Mycobacterium tuberculosis.
Time frame: up to 3.5 years
Comparison of diagnostic efficacy
Using Xpert-MTB/RIF as control technology, the diagnostic efficacy of two kinds of drug resistance detection technology was compared.
Time frame: from January,2015 to December,2018
Evaluation of the application value of probe melting curve technology
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.
Time frame: up to 3.5 years
analyze the cost-effect assessment of probe melting curve technology and other two kinds of detection methods
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.
Time frame: up to 3.5 years
No study locations are listed for this record.
Plan to share: Yes
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Beijing Hospital