Silicosis Tuberculosis Clinical Trial
Official title:
Short Course Rifapentine and Isoniazid for the Preventive Treatment of Tuberculosis(SCRIPT-TB)
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.
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