Short Course Rifapentine and Isoniazid for the Preventive Treatment of Tuberculosis(SCRIPT-TB)

Last updated: April 3, 2019
Sponsor: Huashan Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lung Disease

Hiv

Treatment

N/A

Clinical Study ID

NCT03900858
2017ZX10201302-004
  • Ages 18-65
  • Male

Study Summary

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.

Eligibility Criteria

Inclusion

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 participantassent.

Exclusion

Exclusion Criteria:

  • Clinical or culture confirmed active TB;

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

  • A documented history of a completing an adequate course of treatment for active TB orlatent 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 ofnormal 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.

Study Design

Total Participants: 566
Study Start date:
December 01, 2018
Estimated Completion Date:
June 01, 2022

Study 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, 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.

Connect with a study center

  • Wenling No.1 People's Hospital, Zhejiang

    Taizhou, Zhejiang 317500
    China

    Active - Recruiting

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