Latent tuberculosis infection
Conditions
Interventions
HPMV regimen treatment group:Isoniazid-Rifapentine plus Mycobacterium vaccae(HPMV regimen) prophylactic anti-tuberculosis therapy for 28 days.
Sponsors
The Third People’s Hospital of Shenzhen
Eligibility
Sex/Gender
All
Age
2 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. The age of the patients ranged from 2 to 65 years. 2. If the patients is older than 18 years old, he/she should voluntarily participate and sign the informed consent form. Those aged = 18 years should obtain the consent of their parents or guardians to receive treatment and be able to complete the whole follow-up work, and sign a written informed consent form. 3. Patients should comply with the indications for treatment in " Technical Specifications for tuberculosis Prevention and Control in China (2020 Edition)": a. Students who have close contact with active pulmonary tuberculosis patients and other recently diagnosed LTBI patients. b. LTBI among HIV infected persons, or individuals who are not found positive in the infection test but the clinician thinks it is necessary to treat them. c. LTBI of children under 5 years old who have close contact with pathogenic positive pulmonary tuberculosis patients. d. Other people, including those who need to use tumor necrosis factor therapy, long-term dialysis, those who are ready for organ transplantation or bone marrow transplantation, silicosis patients, and LTBI patients who have long-term use of glucocorticoids or other immunosuppressants.
Exclusion criteria
Exclusion criteria: 1. Suspected or confirmed active tuberculosis after clinical evaluation. 2. The patients had a history of exposure to isoniazid/rifampicin/rifapentine resistant tuberculosis patients. 3.Patients with known allergy or intolerance to isoniazid/rifampicin/rifapentine; The contraindication of isoniazid/rifapentine/mycobacterium vaccae use is found after inquiring about the medical history or conducting examinations (such as blood routine test, liver and kidney functions, etc.); Drugs with significant interactions with isoniazid/rifampicin/rifapentine are being used. 4. Patients with acute febrile disease, severe heart disease, severe liver and kidney dysfunction, severe anemia, diabetes, excessive alcohol use, smoking, and underweight. 5. It is not appropriate to receive preventive treatment if one of the following conditions occurs: a. Severely allergic or in a period of allergic reaction. b. Those undergoing treatment for active viral hepatitis or with elevated serum alanine aminotransferase. c. Patients with blood system diseases, platelet count < 50*10^9/L, white blood cell count <3000*10^9/L. d. Epilepsy patients, psychiatric patients, and those receiving antipsychotic drug treatment. e. Patients who are known to have poor compliance before taking medicine and cannot adhere to the prescribed course of treatment. f. Patients who have suffered from tuberculosis in the past and completed standard anti tuberculosis treatment within 5 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of people who have completed treatment;Completion rate of treatment;Incidence rate of local adverse reactions;Incidence rate of systemic adverse reactions;Incidence rate of organic injury; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change rate of peripheral blood CD3 count before and after treatment;Change rate of peripheral blood CD4 count before and after treatment;Change rate of peripheral blood CD8 count before and after treatment;Change rate of peripheral blood CD4+/CD8+ratio before and after treatment; | — |
Countries
China
Contacts
Public ContactHUANG Jiamin
The Third People’s Hospital of Shenzhen
Outcome results
None listed