A Phase 3 interventional study of Weekly INH / RRT given by DOT in Silicosis and Tuberculosis, sponsored by Huashan Hospital. Completed at 1 site in China. Open to male participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-06-30.
Sponsored by Huashan Hospital · Phase 3, Interventional, and Prevention
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, the three-month (12-dose) regimen of weekly rifapentine and isoniazid (3RPT/INH) are now recommended by WHO for its non-inferiority, safety and convenience compared with 6\~9 months regimen of daily isoniazid monotherapy or 3\~4 months daily rifampicin monotherapy. And the treatment completion rate is higher compared with daily regimen. However, relevant study is lacking in China where the TB burden is high with the incidence rate of 70/100, 000. And the provision of chemoprophylaxis is not recommended in China currently.
Silicosis is a high risk factor of Mycobacterium tuberculosis infection. This is an open-label, randomized, Phase III clinical trial to evaluate the effectiveness and tolerability of the 3RPT/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, the three-month (12-dose) regimen of weekly rifapentine and isoniazid (3RPT/INH) are now recommended by WHO for its non-inferiority, safety and convenience compared with 6\~9 months regimen of daily isoniazid monotherapy or 3\~4 months daily rifampicin monotherapy. And the treatment completion rate is higher compared with daily regimen. However, relevant study is lacking in China where the TB burden is high with the incidence rate of 70/100, 000.
Silicosis is a high risk factor of Mycobacterium tuberculosis infection. This is an open-label, randomized, Phase III clinical trial to evaluate the effectiveness and tolerability of the 3RPT/INH to prevent tuberculosis (TB) among silicotic patients.
The PRIMARY objective of this open-label, randomized, Phase III clinical trial is to evaluate the effectiveness of the 3RPT/INH to prevent TB compared with those who do not receive preventive treatment among eligible silicotic patients.
The SECONDARY objective:
Describe the safety profile of 3RPT/INH in China (the rates of drug discontinuation for any reason and due to adverse drug reactions associated with 3RPT/INH, the rates of any grade 3, 4, or 5 drug toxicity associated with 3RPT/INH) Describe the treatment completion rates of 3RPT/INH. Describe patterns of antibiotic resistance of M. tuberculosis isolates in patients who develop TB despite preventive treatment.
Compare the results of QuantiFERON Gold In-Tube before and after preventive treatment.
For assessment of the primary outcome, development of TB, a sample size of approximately 280 persons per arm will be required with 3 years follow-up.
Exclusion Criteria:
Weekly INH / RRT given by DOT
Drug: Weekly INH / RRT given by DOT
Follow up without intervention
weekly oral Rifapentine 15 mg/kg (up to 900mg) plus Isoniazid 15 mg/kg (up to 900mg) for 12 doses
Also known as: isoniazid, I, INH, rifapentine, RPT, 3 RPT/INH
Cumulative rate of culture-confirmed or clinically diagnosed TB disease in participants
Time frame: 3 years
Percentage of participants with drug discontinuation for any reason and due to adverse drug reactions associated with 3RPT/INH
Time frame: 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 3RPT/INH
Time frame: up to 30 days after the last dose of study drug
Percentage of participants who complete the treatment regimen
Time frame: Enrollment up to Month 3 (3RPT/INH)
The proportion of rifampicin and/or isoniazid resistance of M. tuberculosis isolates in patients who develop TB in preventive treatment group.
Time frame: 3 years
Measure the quantitative and qualitative changes of the results of QuantiFERON Gold In-Tube before and after preventive treatment.
Time frame: Enrollment up to 3 months after preventive treatment
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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Huashan Hospital