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

  • STATUS
    Recruiting
  • End date
    Jun 1, 2022
  • participants needed
    566
  • sponsor
    Huashan Hospital
Updated on 22 January 2021

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.

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.

Details
Condition Silicosis Tuberculosis
Treatment Isoniazid;Rifapentine
Clinical Study IdentifierNCT03900858
SponsorHuashan Hospital
Last Modified on22 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 65 yrs?
Are you male?
Do you have any of these conditions: Do you have Silicosis Tuberculosis??
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
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