Tuberculosis
Conditions
Interventions
Gold Standard:
Index test:
Sponsors
Shanghai Public Health Clinical Center
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Tuberculosis patients inclusion criteria: 1. According to People's Republic of China Health Industry Standard WS288-2008 tuberculosis diagnostic criteria, a diagnosis of pulmonary tuberculosis patients; 2. Aged 18-65 years old, male or female; 3. Subjects agreed to participate in this study and signed informed consent; 4. Subjects can comply with the requirements of the clinical trials to participate in follow-up programs. Initial Treatment of Pulmonary tuberculosis Inclusion criteria: to meet any one of the following three judges can be selected: 1. Have not yet started anti- tuberculosis treatment; 2. Ongoing standard chemotherapy drugs and less than a course; 3. Irregular chemotherapy less than one month; In this clinical trial the initial treatment of pulmonary tuberculosis patients should meet "unfinished intensive phase of chemotherapy." Retreatment tuberculosis inclusion criteria: to meet any one of the following four judges can be selected: 1. Patients with early treatment failure; 2. Regular medication in full course and sputum return into positive 3. Irregular chemotherapy than one month; 4. Patients with chronic discharge bacteria; In this clinical trial the retreatment tuberculosis patients should meet "unfinished intensive phase of chemotherapy." Pulmonary tuberculosis with sputum bacteria positive Inclusion criteria: Acid-fast bacilli smear-positive in 1-3 months before the trialto meet any one of the following four can be selected: 1. Two acid-fast bacilli sputum smear positive; 2. A acid-fast bacilli sputum smear positive and pulmonary imaging with typical manifestations of tuberculosis; 3. A acid-fast bacilli sputum smear positive and a Mycobacterium tuberculosis culture positive; 4. A acid-fast bacilli sputum smear negative,Mycobacterium tuberculosis culture positive ,pulmonary imaging performance typical manifestations of tuberculosis. Pulmonary tuberculosis with sputum bacteria negative inclusion criteria: three sputum smear and one sputum culture-negative. With three items of the following 1-6 or any one of 7-8 can be selected : 1. Typical symptoms of tuberculosis and chest X-ray findings; 2. TB treatment is effective; 3. Clinical diagnosis exclude other non-tuberculous lung disease; 4. PPD (5TU) severe positive ,serum TB antibody positive ; 5. PCR + probe sputum-positive ; 6. lung tissue outside the confirmed tuberculosis; 7. Bronchoalveolar lavage fluid (BALF) detection of acid-fast mycobacteria; 8. Bronchus or lung tissue pathology confirmed tuberculosis; Extrapulmonary TB patients inclusion criteria:The epidemiology, clinical manifestations, imaging, etiological examination, pathological examination and other laboratory examinations diagnosis extrapulmonary TB patientspatients,and tuberculosis involving in the site other than the lungs.In this clinical trial the extrapulmonary TB patients should meet "unfinished intensive phase of chemotherapy." Other patients with non-tuberculous disease inclusion critera: 1. Have a clear lung disease, but clinicians based on clinical manifestations, imaging and laboratory tests can rule out tuberculosis; 2. Aged 18-65 years old, male or female; 3. Subjects agreed to participate in this study and signed informed consent; 4. Subjects can comply with the requirements of the clinical trials to participate in follow-up programs.
Exclusion criteria
Exclusion criteria: Tuberculos Patients Exclusion criteria: 1. The consolidation of the following serious disease such as advanced tumors,chronic obstructive pulmonary disease with acute exacerbation,acute or progressive liver disease or kidney disease,congestive heart failure decompensation,etc; 2. Subjects are participating in other clinical trials;Subjects have participated in any other clinical trials within three months before; 3. Severe allergies,have allergy histories of two or more drugs; 4. Pregnant or lactating women; 5. Exacerbation of mental illness patients; 6. Researchers think there is poor compliance,past history,physical examination or laboratory test results,which are likely to affect any of the trial evaluation. Other patients with non-tuberculous disease Exclusion criteria: 1. The consolidation of the following serious disease such as advanced tumors,chronic obstructive pulmonary disease with acute exacerbation,acute or progressive liver disease or kidney disease,congestive heart failure decompensation,etc; 2. Subjects are participating in other clinical trials;Subjects have participated in any other clinical trials within three months before; 3. Severe allergies,have allergy histories of two or more drugs; 4. Pregnant or lactating women; 5. Exacerbation of mental illness patients; 6. have history of tuberculosis; 7. Researchers think there is poor compliance,past history,physical examination or laboratory test results,which are likely to affect any of the trial evaluation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate sensitivity (positive coincidence rate), specificity (negative coincidence rate) and compliance rate of TB-PPD, garma-IFN (T-SPOT) , EC allergen) in tuberculosis patients and other patients with non-tuberculous disease;Evaluate the safety of EC allergen in tuberculosis patients and other patients with non-tuberculous disease; | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the correlation of TB-PPD, garma-IFN (T-SPOT) , EC allergens in tuberculosis patients and other patients with non-tuberculous disease; | — |
Countries
China
Contacts
Public ContactLifeng Tao
Outcome results
None listed