Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Affiliated Wenling Hospital of Wenzhou Medical University | OTHER |
Not provided
Not provided
Not provided
Not provided
Tuberculosis (TB) remains the most important infectious disease in the world. Preventive treatment plays an important role in successful control of TB. The investigators' previous study showed a 3-month weekly rifapentine and isoniazid regimen had a high protective efficacy but an unsatisfactory completion rate. Therefore, the investigators suppose that a one-month (12-dose) regimen of rifapentine and isoniazid (1RPT/INH) to be equivalent to a 3-month weekly rifapentine and isoniazid regimen with similar efficacy and higher completion rate. Relevant study is lacking in China where the TB burden is high with the incidence rate of 70/100, 000.
Silicosis is a risk factor of Mycobacterium tuberculosis infection. This is an open-label, non-randomized clinical trial to evaluate the efficacy and safety of the 1RPT/INH to prevent tuberculosis (TB) compared with those who do not receive preventive treatment among silicotic patients.
Tuberculosis (TB) remains the most important infectious disease in the world. Preventive treatment plays an important role in successful control of TB. For preventive therapy, alternative shortened courses such as 1-month daily rifapentine and isoniazid have been evaluated in HIV-infected individuals for its non-inferiority, safety and convenience compared with traditional monotherapy. And the treatment completion rate is higher. The investigators' previous study showed a 3-month weekly rifapentine and isoniazid regimen had a high protective efficacy but an unsatisfactory completion rate. Therefore, the investigators suppose that a one-month (12-dose) regimen of rifapentine and isoniazid (1RPT/INH) to be equivalent to a 3-month weekly rifapentine and isoniazid regimen with similar efficacy and higher completion rate. Relevant study is lacking in China where the TB burden is high with the incidence rate of 70/100, 000.
Silicosis is a risk factor of Mycobacterium tuberculosis infection. This is an open-label, non-randomized clinical trial to evaluate the efficacy and safety of the 1RPT/INH to prevent tuberculosis (TB) compared with those who do not receive preventive treatment among silicotic patients.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Isoniazid/ Rifapentine 3 times a week | Experimental | Intervention:Isoniazid/ Rifapentine 3 times a week given by DOT oral Rifapentine (450mg) plus Isoniazid (400mg) for 12 doses |
|
| No Intervention | No Intervention | No preventive treatment Follow up without intervention. Have already done. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isoniazidï¼›Rifapentine | Drug | 1 months (12 doses) of three-weekly rifapentine at a dose of 450mg plus isoniazid at a dose of 400mg given under direct observation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative rate of culture-confirmed or clinically diagnosed TB disease in participants | Cumulative rate of culture-confirmed or clinically diagnosed TB disease in participants | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with drug discontinuation for any reason and due to adverse drug reactions associated with 1RPT/INH | Percentage of participants with drug discontinuation for any reason and due to adverse drug reactions associated with 1RPT/INH | up to 30 days after the last dose of study drug |
| Percentage of patients with Grade 3 or 4 drug toxicities and deaths associated with 1RPT/INH |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qiaoling Ruan, MD | Contact | (8621)52889999 | 8123 | 10301010198@fudan.edu.cn |
| Wenhong Zhang, MD,PhD | Contact | (8621)52889999 | 8123 |
| Name | Affiliation | Role |
|---|---|---|
| Wenhong Zhang, MD,PhD | Huashan Hospital of Fudan University,Shanghai,China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wenling No.1 People's Hospital, Zhejiang | Recruiting | Taizhou | Zhejiang | 317500 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40326358 | Derived | Ruan QL, Yang QL, Ma CL, Lin MY, Huang XT, Mao YP, Gao JM, Li JJ, Zhang XN, You ZX, Zheng QQ, Ren YF, Liu XF, Shao LY, Zhang WH. Efficacy and safety of a novel short course rifapentine and isoniazid regimen for the preventive treatment of tuberculosis in Chinese silicosis patients: a pilot study (SCRIPT-TB). Emerg Microbes Infect. 2025 Dec;14(1):2502010. doi: 10.1080/22221751.2025.2502010. Epub 2025 May 16. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C018421 | rifapentine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Percentage of patients with Grade 3 or 4 drug toxicities and deaths associated with 1RPT/INH |
| up to 30 days after the last dose of study drug |
| Percentage of participants who complete the treatment regimen | Percentage of participants who complete the treatment regimen | Enrollment up to Month 1 (1RPT/INH) |