Efficacy of Weekly Rifapentine and Isoniazid for Tuberculosis Prevention
Status:
Completed
Trial end date:
2018-06-01
Target enrollment:
Participant gender:
Summary
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.