tuberculosis
Conditions
Interventions
Experimental group:blinded
control group:blinded
Sponsors
Wuhan Infectious Disease Hospital
Eligibility
Sex/Gender
All
Age
No minimum to 65 Years
Inclusion criteria
Inclusion criteria: Selection criteria for tuberculosis patients: (1) Subjects aged 15 to 65 years (including 15 and 65 years old) are based on the "People's Republic of China Health Industry Standards for Tuberculosis Diagnosis (WS288-2017)" and the "Guidelines for the Diagnosis and Treatment of Tuberculosis" formulated by the Chinese Medical Association Tuberculosis Branch Subjects who are clinically diagnosed or diagnosed with tuberculosis; (2) Subjects under 15 years old (not including 15 years old) were diagnosed or diagnosed as pulmonary tuberculosis according to the standard clinical diagnosis of pulmonary tuberculosis in accordance with the "Clinical Diagnosis Standards and Treatment Plan for Children's Tuberculosis" (trial implementation) formulated by the Respiratory Group of the Pediatrics Branch of the Chinese Medical Association Subject; (3) I (and/or guardian) agree to participate in this trial and sign an informed consent form; (4) I (and/or guardian) can participate in the follow-up in compliance with the requirements of the clinical trial protocol. Inclusion criteria for patients with extrapulmonary tuberculosis: (1) A patient diagnosed as extrapulmonary tuberculosis by epidemiology, clinical manifestations, imaging examination, etiological examination, pathological examination and other auxiliary examinations, and the tuberculosis lesion involves parts other than the lung. Combining the characteristics of this clinical study and on-site implementation, the enrollment of patients with extrapulmonary tuberculosis needs to meet the "intensified chemotherapy phase"; (2) I (and/or guardian) agree to participate in this trial and sign an informed consent form; (3) I (and/or guardian) can follow the requirements of the clinical trial protocol to participate in the follow-up.
Exclusion criteria
Exclusion criteria: (1) Suffering from acute infectious diseases (such as measles, whooping cough, influenza, pneumonia, etc.), acute ocular conjunctivitis, acute otitis media, generalized skin diseases and allergies (have a history of allergies to two or more drugs or food, Or those who are known to have allergies and scars to the components of this medicine); (2) Suffer from any serious disease, such as: tumor, progressive atherosclerosis or diabetes with complications, chronic obstructive pulmonary disease requiring oxygen therapy, acute or progressive liver disease or kidney disease, congestive heart failure, etc.; (3) Those who have convulsions, epilepsy, have a history of mental illness and/or a family history of mental illness; (4) Those who have known or suspected (or high-risk) immune function impairment or abnormalities, such as those receiving immunosuppressant or immunopotentiator treatment, receiving glucocorticoids within 3 months, or those outside the gastrointestinal tract Immunoglobulin preparations or blood products or plasma extracts, human immunodeficiency virus infections or related diseases; (5) The human immunodeficiency virus (HIV) antibody test result is positive; (6) The interval between inoculation of live attenuated vaccine is less than 28 days, and the interval of other vaccines is less than 14 days; (7) Before the skin test, it is in the acute disease stage or the acute onset of chronic disease (3 days before the skin test); (8) Those who are participating in or have participated in any other clinical research within 3 months before this clinical research; (9) Women who are pregnant or breastfeeding, or who plan to become pregnant during the study period; (10) Have a clear history of hypertension; (11) Suspected or confirmed drug abuse or alcohol abuse; (12) Those with upper limb disabilities; (13) Infants (under 1 year old) weigh less than 2.5kg at birth, or premature babies or dystocia; (14) Infants (under 1 year old) suffer from neonatal respiratory distress syndrome, pathological jaundice, congenital malformations, developmental disorders and congenital diseases; (15) The investigator believes that there are any circumstances that may affect the evaluation of the trial, such as poor compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event; | — |
Secondary
| Measure | Time frame |
|---|---|
| scleroma;blush; | — |
Countries
China
Contacts
Public ContactWei Ming
Wuhan Infectious Disease Hospital
Outcome results
None listed