active tuberculosis
Conditions
Interventions
Group 1HP:Isoniazid and rifapentin combined with prophylactic anti-tuberculosis therapy for 28 days
Sponsors
TheThird people's hospital of Shenzhen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age =18 years, male or female. 2.There is no evidence of active tuberculosis by tuberculosis pathogenesis or clinically diagnosed. 3.One of the following groups of people who meet the recommendations for preventive treatment of tuberculosis in the "2023 Edition of WHO Comprehensive Guidelines for Tuberculosis: Module 1" or the "China Technical Code for Tuberculosis Preventive and Control Work (2023 Edition)": ?Peoples who are in close contact with pathogenic positive pulmonary tuberculosis patients, and the results of tuberculosis immunology test are positive. ? People living with HIV. ?At-risk population: the results of tuberculosis immunology test are positive with one of the following conditions:treatment with anti-tumour necrosis factor; long-term haematological/peritoneal dialysis; preparation for organ transplantation or bone marrow transplantation; silicosis; long-term application of glucocorticoids or other immunosuppressive agents.
Exclusion criteria
Exclusion criteria: 1.Pathogenic or clinically diagnosed tuberculosissuspected tuberculosis.(The diagnostic criteria for active tuberculosis in this study refer to the People's Republic of China health industry standard ). 2.History of exposure to rifampicin-resistant(RR-TB), multidrug-resistant(MDR-TB), or extensively drug-resistant (XDR-TB). 3.History of treatment with isoniazid for=30 consecutive days or rifamycin antibiotics for =14 consecutive days within 2 years prior to enrolment. 4.Allergy to isoniazid and rifapentine. 5.Drugs that have significant interactions with tisoniazid and rifapentine (such as Phenobarbital, acid-forming drugs, probenecid, miconazole or ketoconazole eg.) 6.Those who are participating in a clinical trial of another new drug or have participated in a clinical trial of any other new drug within 3 months prior to prophylactic treatment. 7.Any of the following:?Chronic alcoholics (drinking more than 14 taels (about 7 beers) per week or more than 4 taels (about 2 beers) per drink);?alanine aminotransferase or aspartate aminotransferase > 3 times the upper limit of normal, total bilirubin > 2.5 times the upper limit of normal;?People who are in the acute phase of a disease or anaphylactic reaction;?Patients with a previous history of mental illness and epilepsy, or who are being treated with antipsychotic medication;?Patients with haematological disorders: platelet count <50*10^9/L, white cell count<3000*10^9/L;?Patients with severe immunosuppression, advanced malignancy;?Those who are known to have poor adherence to the prescribed regimen prior to taking the medication;?Previous tuberculosis, within 2 years of completion of standardised anti-tuberculosis treatment. 8.Pregnant or breastfeeding women. 9.The investigator considers the presence of any conditions such as poor adherence, past history, physical examination or laboratory findings that are likely to influence the assessment of the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment completion rate;Incidence rate of adverse events at 3-4 levels;Incidence of adverse reactions associated with anti-tuberculosis drugs; | — |
Secondary
| Measure | Time frame |
|---|---|
| Validation of the optimal dose of rifapentine in 1HP regimens in HIV-infected and non-HIV-infected individuals; | — |
Countries
Chinia
Contacts
Public ContactWeijian Liu
The Third People's Hospital of Shenzhen
Outcome results
None listed