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 who have been diagnosed with tuberculosis, or tuberculosis patients who have recently started anti-tuberculosis treatment, preferably within 14 days, but no longer than one month (the interval between this treatment and the previous treatment should be more than 6 months); men and women aged 16 to 65; (2) Subjects diagnosed with pulmonary tuberculosis in accordance with the "Diagnostic Criteria for Pulmonary Tuberculosis (WS288-2017)" issued by the People's Republic of China Health Industry Standards (including clinical diagnoses made through comprehensive analysis); (3) For patients with bacteriologically positive pulmonary tuberculosis, proof of positive test results must be provided, including but not limited to positive sputum smear, positive mycobacterial culture, positive Mycobacterium tuberculosis gene test, and positive lung tissue pathological examination. The proportion of bacteriologically negative patients should be =50%; (4) The individual commits to comply with the clinical trial protocol requirements for follow-up, agrees to participate in this trial, and signs the informed consent form; (5) Female participants of childbearing potential (from the onset of menstruation to one year after ovarian function decline/menopause) must test negative for pregnancy before enrollment, have used effective contraceptive measures within the 2 weeks prior to enrollment, have no plans to become pregnant within 28 days after enrollment, and commit to using effective contraception (including: oral contraceptives, injectable or implanted contraception, slow-release local contraceptives, hormone patches, intrauterine devices (IUD), sterilization, abstaining from sexual activity, male condoms, diaphragms, cervical caps, etc.; methods not considered effective include natural family planning, coitus interruptus, and emergency contraception); 2. Inclusion Criteria for Healthy Subjects: (1) *Aged 16-65 years, of any gender, with an axillary temperature <=37.3°C on the day of enrollment; (2) The subject agrees to comply with the requirements of the clinical trial protocol for follow-up, consents to participate in this trial, and signs the informed consent form; (3) According to medical history inquiry, no personal or family history of tuberculosis, no close contact with tuberculosis (referring to direct contact with a registered pulmonary tuberculosis patient from 3 months before their diagnosis to 14 days after starting anti-tuberculosis treatment), no pulmonary or extrapulmonary tuberculosis, no respiratory or other systemic symptoms potentially indicative of tuberculosis. Chest imaging shows no abnormalities; (4) No clinical symptoms of tuberculosis toxicosis (tuberculosis toxicosis symptoms refer to obvious systemic symptoms in addition to local symptoms like cough, chest pain, and chest tightness, such as fatigue, afternoon low-grade fever, loss of appetite, night sweats, etc. Females may have endocrine system disorders, such as irregular menstruation or amenorrhea); (5) No history of heart, liver, kidney, gastrointestinal, nervous system, psychiatric, or metabolic disorders based on inquiry; (6) *Physical examination, electrocardiogram, vital signs, and laboratory tests, including blood routine, blood biochemistry, and urinalysis, are all normal or show abnormalities of no clinical significance; (7) Female subjects of childbearing potential (from the onset of menarche to one year af
Exclusion criteria
Exclusion criteria: 1. Have undergone a tuberculin (PPD) or similar skin test within 3 months prior to enrollment; 2. Suffer from acute infectious diseases (such as measles, whooping cough, influenza, pneumonia, etc.), acute conjunctivitis, acute otitis media, widespread skin disease, or an allergic constitution (those with a history of allergy to two or more drugs or foods, or known allergy to components of this drug, or prone to scarring); 3. Have congenital malformations, developmental disorders, congenital diseases, or any serious illness, such as progressive atherosclerosis, poorly controlled diabetes (judged by the investigator as unsuitable for participation), chronic obstructive pulmonary disease requiring oxygen therapy, acute or progressive liver or kidney disease, congestive heart failure, or diseases with rash and pyoderma; 4. Have a history of convulsions, epilepsy, encephalopathy, or neurological symptoms or signs; 5. Have known or suspected (or at high risk for) immune dysfunction or abnormalities, including: (1) *Within 3 months, or currently receiving immunosuppressants (including chemotherapy) or immunostimulants, such as long-term systemic corticosteroid therapy (continuous use for 2 weeks or more, 2 mg/kg/day or 20 mg/day prednisone or equivalent; local treatments such as ointments, eye drops, inhalants, or nasal sprays are allowed), thymosin, interleukin, interferon, lentinan, BCG-PSN, etc.; (2) *Within 3 months, received immunoglobulin products or blood products or plasma treatments; (3) Patients with malignant tumors; (4) HIV infection; 6. *Acute febrile illness (excluding tuberculosis); 7. *Received a non-live vaccine within 7 days before the skin test, or a live attenuated vaccine within 28 days; 8. Currently participating in or having participated in any other clinical study within 3 months prior to this study; 9. Pregnant or breastfeeding women; 10. *With a clear history of hypertension and with post-medication control systolic pressure >= 150 mmHg and/or diastolic pressure >= 100 mmHg; 11. Suspected or confirmed drug abuse or alcoholism; mental or physical disabilities affecting observation of skin test injection results; 12. Any situation that the investigator deems likely to affect trial assessment, such as poor compliance. For criteria marked with an asterisk (*), if the subject meets such criteria, visits can be rescheduled once these conditions no longer exist.
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 positive detection rate in tuberculosis patients, negative compliance rate in healthy participants, and consistency of IGRA responses at each observation time point;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.; | — |
Countries
China
Contacts
Public ContactJuan Du; Guan Liu
Wuhan Pulmonary Hospital
Outcome results
None listed