Pulmonary Tuberculosis
Conditions
Interventions
Sponsors
Wuhan Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
16 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Inclusion criteria for tuberculosis patients: (1) Patients with confirmed tuberculosis or tuberculosis patients who have started anti-tuberculosis therapy should preferably be within 14 days and no more than 1 month (the interval between the start of treatment and the discontinuation of the previous treatment is greater than 6 months); Male or female aged 16 to 65; (2) Subjects who meet the "Diagnostic Criteria for Pulmonary Tuberculosis of the People's Republic of China Health Industry Standard (WS288-2017)" (recognized diagnosis made by comprehensive clinical analysis); (3) Patients with positive etiology-positive pulmonary tuberculosis need to provide positive test results, including but not limited to positive sputum smear, positive mycobacterial isolation culture, positive Mycobacterium tuberculosis genetic test, and positive lung histopathology test. The proportion of patients with negative etiology >=50%; (4) I promise to comply with the requirements of the clinical trial protocol to participate in the follow-up, agree to participate in this trial and sign the informed consent form; (5) Female subjects of childbearing age (women within one year after the development and maturity of female reproductive organs (menarche) to ovarian function decline (menopause)) have a negative pregnancy test test before enrollment, and have taken effective contraceptive measures within 2 weeks before inclusion in this study, and have no birth plan within 28 days after enrollment, and commit to taking effective contraceptive measures (including: oral contraceptives, injectable or implanted contraception, extended-release topical contraceptives, hormone patches, intrauterine devices (IUDs), sterilization, avoidance of sexual activity, Condoms (males), diaphragms, cervical caps, etc.; Contraceptive measures that are not considered effective are safe period contraception, external ejaculation method, emergency contraception, etc.). 2. Healthy Subject Inclusion Criteria: (1) *Age 16-65 years old, male or female, axillary body temperature <=37.3°C on the day of enrollment; (2) I promise to comply with the requirements of the clinical trial protocol to participate in the follow-up, agree to participate in this trial and sign the informed consent form; (3) No history of tuberculosis, family history of tuberculosis, and close contact with tuberculosis (referring to direct contact with registered tuberculosis patients within 3 months before diagnosis to 14 days after starting anti-tuberculosis therapy), no internal or external tuberculosis, and no respiratory symptoms of tuberculosis and other parts of the body. Chest imaging examination without abnormalities; (4) No clinical symptoms of tuberculosis poisoning (tuberculosis poisoning symptoms refer to local symptoms such as cough, chest pain, and chest tightness, as well as obvious systemic symptoms, such as fatigue, low-grade fever in the afternoon, loss of appetite, night sweats, etc.) Women may have endocrine system disorders, such as irregular menstruation, amenorrhea, etc.); (5) No history of heart, liver, kidney, digestive tract, nervous system, mental and metabolic abnormalities after consultation; (6) *Physical examination, electrocardiogram, vital signs and laboratory examinations including blood routine, blood biochemistry, and urine routine are normal or abnormal and have no clinical significance; (7) Female subjects of childbearing age (women who are in the maturity of female reproductive orga
Exclusion criteria
Exclusion criteria: 1.*Skin test of tuberculin (PPD) or similar products within 3 months prior to enrollment; 2. Suffering from acute infectious diseases (such as measles, whooping cough, influenza, pneumonia, etc.), acute ocular conjunctivitis, acute otitis media, generalized skin diseases and allergies (those who have a history of allergy to two or more drugs or foods, or known allergies and scars to the components of this drug); 3. Suffering from congenital malformations, developmental disorders, congenital diseases, and any serious diseases, such as: progressive atherosclerosis or poor blood sugar control, diabetes mellitus judged by the investigator to be unsuitable for the trial, chronic obstructive pulmonary disease requiring oxygen therapy, acute or progressive liver disease or kidney disease, congestive heart failure, skin rash and pyoderma and other diseases; 4. Those who have a history of convulsions, epilepsy, encephalopathy, and neurological symptoms or signs; 5. Those who have known or suspected (or high-risk) immune damage or abnormalities, including: (1) *Those who are receiving immunosuppressants (including chemotherapy) or immuno-enhancer therapy within 3 months, such as long-term use of systemic glucocorticoids (2 consecutive weeks or more, dose of 2mg/kg/day or 20mg/day prednisone or equivalent); Topical medications (such as ointments, eye drops, inhalants, or nasal sprays)), thymus peptides, interleukins, interferons, shiitake polysaccharides, BCG-PSN, etc. are allowed; (2) *Those who have received immunoglobulin preparations or blood products or plasma extraction treatment within 3 months; (3) Patients with malignant tumors; (4) HIV-infected individuals; 6.*Acute febrile illness (except tuberculosis patients); 7. *Vaccination with non-live vaccines within 7 days or live attenuated vaccines within 28 days before the skin test; 8. Is participating in or has participated in any other clinical investigator within 3 months before this clinical study; 9. Pregnant and lactating women; 10.*Has a clear history of hypertension and systolic blood pressure >=150 mmHg and/or diastolic blood pressure >=100 mmHg after drug control; 11. Suspected or confirmed drug abuse or alcoholism; Observers whose mental and physical disabilities affect the results of skin test injections; 12. Any condition that the investigator believes may affect the evaluation of the trial, such as poor compliance. For criteria marked with an asterisk (*), if the subject has the conditions specified in that criterion, the visit can be rescheduled if they no longer have those conditions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The positive detection rate of EM and the average diameters of induration and erythema in tuberculosis patients at each observation time point;The positive detection rate of EM and the average diameters of induration and erythema in healthy participants at each observation time point; | — |
Secondary
| Measure | Time frame |
|---|---|
| The consistency of IGRA results before and 24 hours, 72 hours, and 7 days after the skin test in the medium-dose and high-dose groups of tuberculosis patients and healthy participants.;The positive detection rate in tuberculosis patients, negative compliance rate in healthy participants, and consistency of IGRA responses at each observation time point; | — |
Countries
China
Contacts
Public ContactLiu Guan
Wuhan Pulmonary Hospital
Outcome results
None listed