Efficacy of Weekly Rifapentine and Isoniazid for Tuberculosis Prevention

• Status: Completed
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Huashan Hospital
• Treatments: Isoniazid; Rifampin; Rifapentine

Criteria

Inclusion Criteria:

• Individuals with Silica exposure or diagnosed with silicosis;

• Age between 18 to 65 years;

• Willing to provide signed informed consent, or parental consent and participant assent.

Exclusion Criteria:

• Clinical or culture confirmed active TB;

• A history of treatment for > 14 consecutive days with a rifamycin or > 30 consecutive days with INH during the previous 2 years;

• A documented history of a completing an adequate course of treatment for active TB or latent TB infection;

• Allergy to Isoniazid, Rifampin, or Rifapentine;

• Human immunodeficiency virus (HIV) infection;

• History of hepatitis B/C infection or liver cirrhosis;

• Serum Aspartic transaminase (AST) or alanine transaminase (ALT) > 2x upper limit of normal or total bilirubin >2.5 mg/dL;

• Receiving immunosuppressants or biological agents;

• Life expectancy <3 years;

• Mental disorder;

• Participated in other clinical trials in recent three months;

• Other conditions that investigates consider not suitable for participate.