Tuberculosis
Conditions
Interventions
Gold Standard:The gold standard for the diagnosis of TB is TB culture, and the reference standard for latent TB infection is QFT.
Index test:IP-10 mRNA release assay
Sponsors
The Third People's Hospital of Shenzhen
Eligibility
Sex/Gender
All
Age
No minimum to 18 Years
Inclusion criteria
Inclusion criteria: 1. Suspected tuberculosis inclusion criteria: (1) Suspected tuberculosis inclusion criteria: 1) Refer to the Diagnostic Criteria for Tuberculosis of the People's Republic of China Health Industry Standards (WS288-2017) and the Guidelines for the Diagnosis and Treatment of Tuberculosis formulated by the Tuberculosis Branch of the Chinese Medical Association: with cough, coughing up sputum which may be accompanied by hemoptysis, chest pain, dyspnea; fever (often afternoon low-grade fever) which may be accompanied by symptoms or signs such as night sweats, fatigue, decreased appetite, weight loss, or other symptoms or signs that are easily confused with pulmonary tuberculosis. Other respiratory diseases that are easily confused with tuberculosis. 2) Children and adolescents aged =18 years, both male and female; 3) Agree to participate in this trial and sign the informed consent form; 4) The subjects can comply with the requirements of the clinical trial program and participate in the follow-up visits. (2) Suspected extrapulmonary tuberculosis inclusion criteria: Patients with suspected extrapulmonary tuberculosis diagnosed by epidemiology, clinical manifestations, imaging examination, pathogenetic examination, pathologic examination and other auxiliary examinations, and with tuberculosis foci involving parts other than the lungs. Combined with the characteristics of this clinical study and its implementation in the field. 2.Non-tuberculosis lung disease inclusion criteria: 1) Subjects with definite lung disease, but the clinician can exclude tuberculosis based on the patient's clinical presentation, imaging and laboratory examination; 2) Children and adolescents aged =18 years, male and female; 3) I agree to participate in this trial and sign the informed consent form; 4) Subjects can comply with the requirements of the clinical trial program to participate in follow-up visits. 3.Inclusion criteria for tuberculosis close contacts: 1) Children and adolescents aged =18 years, male and female; 2) Identified as close contacts of patients with sensitive Mycobacterium tuberculosis infection. Definition of close contacts: those who have direct contact with bacillus-positive TB patients from 3 months before their diagnosis to 2 weeks after the start of anti-tuberculosis, which can be categorized into intra-household close contacts (including people living in the same household or guests who often come to the house) and extra-household close contacts (including work colleagues, schoolmates, etc.). 3) The subject agrees to participate in the trial and signs the informed consent form; 4) The subjects themselves can comply with the requirements of the clinical trial program to participate in follow-up visits.
Exclusion criteria
Exclusion criteria: 1. Exclusion criteria for tuberculosis patients: 1) Combination of the following serious diseases, such as advanced tumors, hematologic diseases, acute or progressive liver or kidney disease, and decompensated stage of heart failure; 2) Those who are participating in the clinical trial of other new drugs or those who have participated in the clinical trial of any other new drugs within 3 months before the clinical trial; 3) Those with severe allergies and a history of allergy to two or more drugs; 4) Patients with psychiatric exacerbations; 5) Receiving anti-tuberculosis treatment for more than 4 weeks. 6) Receiving immunosuppressive therapy for more than 1 month. 7) Any condition that, in the opinion of the investigator, is characterized by poor adherence, past history, physical examination or laboratory findings that may affect the evaluation of the trial. 2.Exclusion criteria for patients with non-tuberculosis lung disease: 1) Combination of the following serious diseases, such as advanced tumors, hematologic diseases, acute or progressive liver or kidney disease, and decompensated stage of heart failure; 2) Those who are participating in the clinical trial of other new drugs or those who have participated in the clinical trial of any other new drugs within 3 months before the clinical trial; 3) Those with severe allergies and a history of allergy to two or more drugs; 4) Patients with psychotic episodes; 5) Those with a previous history of tuberculosis; 6) Any condition that the investigator believes that there is poor compliance, past history, physical examination or laboratory test results that may affect the evaluation of the trial. 3.Exclusion criteria for tuberculosis close contacts: 1) Combination of the following serious diseases, such as advanced tumors, hematologic diseases, acute or progressive liver or kidney disease, and decompensated stage of heart failure; 2) Those who are participating in clinical trials of other new drugs or those who have participated in clinical trials of any other new drugs within 3 months before the clinical trial; 3) Those with severe allergies and a history of allergy to two or more drugs; 4) Patients with psychotic episodes; 5) Those with a previous history of tuberculosis; 6) Any condition that, in the opinion of the investigator, is characterized by poor adherence, past history, physical examination or laboratory test results that may affect the evaluation of the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| sensitivity;specificity; | — |
Secondary
| Measure | Time frame |
|---|---|
| diagnostic consistency; | — |
Countries
China
Contacts
Public ContactShuihua Lu
The Third People's Hospital of Shenzhen
Outcome results
None listed