Tuberculosis Clinical Trial
Official title:
Effectiveness and Tolerability of Weekly Rifapentine/Isoniazid for 3 Months for Tuberculosis Preventive Treatment: A Randomized Controlled Study in China
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.
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