Clinical Trial: Efficacy of Weekly Rifapentine and Isoniazid for Tuberculosis Prevention

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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 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.

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
Sponsor: Huashan Hospital

Current Primary Outcome: Cumulative rate of culture-confirmed or clinically diagnosed TB disease in participants [ Time Frame: 3 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Percentage of participants with drug discontinuation for any reason and due to adverse drug reactions associated with 3RPT/INH [ Time Frame: up to 30 days after the last dose of study drug ]
  • Percentage of patients with Grade 3 or 4 drug toxicities and deaths associated with 3RPT/INH [ Time Frame: up to 30 days after the last dose of study drug ]
  • Percentage of participants who complete the treatment regimen [ Time Frame: Enrollment up to Month 3 (3RPT/INH) ]
  • The proportion of rifampicin and/or isoniazid resistance of M. tuberculosis isolates in patients who develop TB in preventive treatment group. [ Time Frame: 3 years ]
  • Measure the quantitative and qualitative changes of the results of QuantiFERON Gold In-Tube before and after preventive treatment. [ Time Frame: Enrollment up to 3 months after preventive treatment ]


Original Secondary Outcome: Same as current

Information By: Huashan Hospital

Dates:
Date Received: April 16, 2015
Date Started: March 2015
Date Completion: December 2018
Last Updated: April 25, 2015
Last Verified: April 2015