tuberculosis
Conditions
Interventions
Intervention group:The intervention group received a combination of isoniazid and rifapentine for 4 weeks (twice a week, with a maximum dose of 600 mg each time) and M.vaccae injection 3 times (once e
Control group:No intervention
Sponsors
Institute of Pathogen Biology, Chinese Academy of Medical Sciences and Peking Union Medical College; The Center for Disease Prevention and Control of Zhongmu County, Zhengzhou
Eligibility
Sex/Gender
All
Age
50 Years to 70 Years
Inclusion criteria
Inclusion criteria: Baseline Investigation Phase: a.Age 50-70 years old (date of birth between January 1, 1953 and December 31, 1972); b. Local household registration population or permanent resident population (more than 6 months), and can guarantee to complete the entire research cycle; c. Voluntarily sign the informed consent form and cooperate with the completion of the research content. Intervention phase: Positive for Mycobacterium tuberculosis infection.
Exclusion criteria
Exclusion criteria: Baseline Investigation Phase: a. Existing patients with tuberculosis; b. Women who are pregnant, breastfeeding or planning to become pregnant; c. History of tuberculosis preventive treatment; d. Epilepsy patients or those taking anti-epileptic drugs; e. Those who are incapacitated due to mental disorders, deaf-mute disabilities, inconvenience of movement, etc., who cannot cooperate with the trial or who cannot promise to complete the entire research cycle, and other situations judged by the investigator to be unsuitable to participate in this study. Intervention phase: a. Suspected cases or current patients with active pulmonary tuberculosis; b. History of drug-resistant TB or TB within the past two years; c. Women who are pregnant, breastfeeding or planning to become pregnant; d. Those with a history of drug allergies, vaccine allergies or those with allergic constitution; e. Those with acute or progressive liver disease or kidney disease or abnormal liver and kidney function; f. Patients with biliary obstruction; g. Anti-HCV antibody positive; h. Patients with febrile disease, severe heart disease, severe hypertension, myocardial damage, significant vascular sclerosis, and endocarditis; i. Extremely weak and severe anemia, thrombocytopenia, leukopenia or coagulation dysfunction; j. Those with serious diseases (such as malignant tumors), autoimmune diseases or those who use immunosuppressants, mental illnesses, deaf-mute disabilities, etc. who do not have full capacity, cannot cooperate with the completion of the project content and the researchers judge that they are not suitable to participate in this project.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of tuberculosis; | — |
Secondary
| Measure | Time frame |
|---|---|
| Individual compliance;Occurrence of adverse events;Overall adherence; | — |
Countries
China
Contacts
Public ContactLei Gao
Institute of Pathogen Biology, Chinese Academy of Medical Sciences and Peking Union Medical College
Outcome results
None listed