Tuberculosis
Conditions
Interventions
Community-dwelling population aged 3 to 64 years:EEC&EC
Community-dwelling population above 65 years&Triple Yin Population:EEC&TB-PPD
Tuberculosis Participants aged 3 to 64 years:EEC&EC
Tuberculosis Participants above 65 years:EEC&TB-PPD
Participants with non-tuberculous lung disease aged 3 to 64 years:EEC&EC
Participants with non-tuberculous lung disease above 65 years:EEC&TB-PPD
Sponsors
Beijing Chest Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
3 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Inclusion criteria for the general population in the community: 1) Aged 3 years and above at the time of enrollment, regardless of gender; 2) The individual and/or guardian agree to participate in this trial and sign the informed consent form; 3) The individual and/or guardian can comply with the requirements of the clinical trial protocol to participate/accompany the participants to participate in the follow-up; 4) No history of tuberculosis (including intrapulmonary and extrapulmonary tuberculosis) after medical history inquiry; 5) No clinical symptoms of tuberculosis poisoning. Tuberculosis poisoning symptoms refer to obvious systemic symptoms such as fatigue, low fever in the afternoon, loss of appetite, night sweats, etc. in addition to local symptoms such as cough, chest pain, and chest tightness. Women may have endocrine system disorders, such as irregular menstruation, amenorrhea, etc.; 6) Inclusion criteria for triple-negative population: People with negative results of the first skin test on both arms and IGRA test results (i.e., negative results of EEC, TB-PPD, and IGRA tests). 2. Inclusion criteria for patients with tuberculosis (including pulmonary tuberculosis): 1) Age 3 years and above at the time of enrollment, regardless of gender; 2) Participants aged >=18 years were diagnosed with tuberculosis/pulmonary tuberculosis according to the diagnostic standard "Standard Tuberculosis Classification of the Health Industry of the People's Republic of China WS196-2017" issued by the health and health authorities of the State Council (recognizing the diagnosis made by comprehensive clinical analysis); participants aged 3-17 years were diagnosed with tuberculosis according to the "Expert Consensus on Diagnosis of Childhood Pulmonary Tuberculosis (2022 Edition)" formulated by the Children's Tuberculosis Professional Committee of the Tuberculosis Branch of the Chinese Medical Association. Including pulmonary tuberculosis and extrapulmonary tuberculosis, of which pulmonary tuberculosis includes bacteria-negative/bacteria-positive pulmonary tuberculosis and primary/relapsed pulmonary tuberculosis; patients with both pulmonary tuberculosis and extrapulmonary tuberculosis can be included and classified as pulmonary tuberculosis; 3) The individual and/or guardian agree to participate in this trial and sign the informed consent form; 4) The individual and/or guardian can comply with the requirements of the clinical trial protocol to participate in follow-up. 3. Inclusion criteria for patients with non-tuberculous lung diseases: 1) Patients with a clinical diagnosis of clear non-tuberculous lung diseases, and clinical physicians can exclude pulmonary tuberculosis and extrapulmonary tuberculosis based on the patient's clinical manifestations, imaging and laboratory tests, including pneumonia, lung cancer, bronchitis, bronchiectasis, non-tuberculous mycobacterial disease, chronic obstructive pulmonary disease, etc.; 2) Aged 3 years and above at the time of enrollment, regardless of gender; 3) The patient and/or guardian agree to participate in this trial and sign the informed consent form; 4) The patient or guardian can comply with the requirements of the clinical trial protocol to participate in follow-up.
Exclusion criteria
Exclusion criteria: 1. Exclusion criteria for the general population in the community: 1) Those with known or suspected (or high-risk) severe immune diseases, immune function damage or abnormalities (except human immunodeficiency virus [HIV] infection/AIDS), including: a. Those who received immunosuppressants (including chemotherapy) (using medium/high doses of glucocorticoids (>=20mg/d or >=0.5mg/kg/d prednisone or equivalent other hormones), and the medication time was >14 days) or immunopotentiators within 3 days before the skin test or during the trial, and those who were evaluated by the researchers to affect the efficacy of the participants; Note: For glucocorticoid drugs: topical inhalation, nasal spray, local injection, application and other external use, as well as long-term physiological replacement therapy for systemic medication such as oral, intramuscular injection, intravenous injection or intravenous drip, there are no restrictions, such as prednisone or equivalent doses of other drugs with a dose of 5 years old) or =20mg/d or >=0.5mg/kg/d), medication time>14 days) or immunoenhancers within 3 days before the skin test or during the trial, and those who are
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The sensitivity (true positive rate) of the EEC and EC detection methods in tuberculosis patients aged 3 to 64 years;The specificity (true negative rate) of the EEC and EC assays in patients aged 3 to 64 years with non-tuberculous lung diseases;The specificity (true negative rate) of the EEC and EC tests for the diagnosis of Mycobacterium tuberculosis infection in healthy participants aged 3 to 64 years (with no abnormal imaging, negative IGRA test results, and no symptoms/signs of tuberculosis);The negative rate of EEC test drugs and TB-PPD control drugs in BCG-vaccinated populations in the triple-negative population;The sensitivity (true positive rate) of the EEC test drug compared with the control IGRA and TB-PPD for assisting clinical diagnosis of TB in TB patients aged 65 years and above;To evaluate the consistency (accordance rate) of the diagnostic results between EEC and IGRA in non-tuberculous lung diseases in the general community population aged 65 years and above; | — |
Secondary
| Measure | Time frame |
|---|---|
| Verify the participant operating characteristic curve (ROC curve) and area under the curve (AUC) of EEC, and verify the optimal diagnostic threshold, time range, and specific reaction type (redness or induration) of the test drug;To evaluate the consistency of skin test results (positive detection rate and negative detection rate) between EEC and EC in the general community population, TB patients, and patients with non-tuberculous lung diseases;3) To evaluate the positive rate of skin test results of EEC and TB-PPD in the general community population;4) The incidence of adverse events (AEs) and serious adverse events (SAEs) in EEC during the trial; | — |
Countries
China
Contacts
Public ContactNaihui Chu/Nie Wenjuan
Beijing Chest Hospital, Capital Medical University
Outcome results
None listed