tuberculosis
Conditions
Interventions
Preventive treatment trial protocol group:Isoniazid+Rifapentin (maximum dose 600 mg), twice a week for a total of 6 weeks
Preventive treatment recommendation group:Isoniazid+Rifapentin (maximum dose 600 mg), twice a week for a total of 3 months
Post exposure intervention group:Isoniazid+Rifapentin (maximum dose 600 mg), twice a week for a total of 6 weeks
Non intervention group after exposure:no intervention
Sponsors
Institute of Pathogen Biology, Chinese Academy of Medical Sciences & Peking Union Medical College
Eligibility
Sex/Gender
All
Age
5 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.In the screening phase (1) Age 5 to 75 (born between January 1, 1951, and January 1, 2021); (2) Close contacts of patients with rifampicin-sensitive pulmonary tuberculosis; (3) Local registered residence population or permanent residents (those who have lived continuously for more than 6 months), capable of ensuring the completion of the entire research period; (4) Voluntarily sign the informed consent form and cooperate in completing the study content. 2. Post-exposure intervention: (1) Individuals with IGRA-negative results in close contact baseline screening; 3. Preventive Therapy for Latent Tuberculosis Infection: (1) Individuals with an IGRA-positive result in close contact baseline screening.
Exclusion criteria
Exclusion criteria: 1. In the screening stage: (1) Pregnant, lactating or women planning to become pregnant; (2) Patients with epilepsy or those taking antiepileptic drugs, or those with other mental disorders that render them unable to fully act; (3) Those with severe diseases (such as malignant tumors), mental disorders, alcoholism, drug abuse, etc., that render them unable to fully act, unable to cooperate with the trial or unable to commit to completing the entire study period, or other conditions deemed unsuitable for participation in this study by the researcher. 2. Post-exposure intervention: (1) Suspected or current cases of active pulmonary tuberculosis; (2) History of tuberculosis or drug-resistant tuberculosis treatment; (3) History of tuberculosis preventive treatment; (4) History of allergy to isoniazid or rifapentine; (5) Biliary obstruction; (6) Acute or progressive liver or kidney disease; (7) HIV-infected individuals; (8) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin (TBIL) >= 2 times the upper limit of normal; (9) Blood system diseases, thrombocytopenia (platelets = 2 times the upper limit of normal; 9) Blood system diseases, thrombocytopenia (platelets < 50×10^9/L) or leukopenia (< 3×10^9/L).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of tuberculosis; | — |
Secondary
| Measure | Time frame |
|---|---|
| Individual compliance;Occurrence of side-effects;Occurrence of adverse events;Overall adherence;IGRA conversion rate; | — |
Countries
China
Contacts
Public ContactXuefang Cao
Institute of Pathogen Biology, Chinese Academy of Medical Sciences & Peking Union Medical College
Outcome results
None listed