Efficacy of Weekly Rifapentine and Isoniazid for Tuberculosis Prevention
Condition: Silicosis; Tuberculosis
MeSH terms: Tuberculosis; Silicosis
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      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.
    

Intervention name(s): Weekly INH / RRT given by DOT
Intervention type(s): Drug
Intervention description(s): weekly oral Rifapentine 15 mg/kg (up to 900mg) plus Isoniazid 15 mg/kg (up to 900mg) for 12 doses
Other intervention name(s): isoniazid; I; INH; rifapentine; RPT; 3 RPT/INH
Intervention MeSH terms: Isoniazid; Rifapentine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: rifapentine; isoniazid; QuantiFERON Gold In-Tube; tuberculin skin test