Silicosis Tuberculosis Clinical Trial
— TBOfficial title:
Short Course Rifapentine and Isoniazid for the Preventive Treatment of Tuberculosis(SCRIPT-TB)
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.
| Status | Recruiting |
| Enrollment | 566 |
| Est. completion date | June 1, 2022 |
| Est. primary completion date | January 1, 2022 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years to 65 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| China | Wenling No.1 People's Hospital, Zhejiang | Taizhou | Zhejiang |
| Lead Sponsor | Collaborator |
|---|---|
| Huashan Hospital | Wenling No.1 People's Hospital, China |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Cumulative rate of culture-confirmed or clinically diagnosed TB disease in participants | Cumulative rate of culture-confirmed or clinically diagnosed TB disease in participants | 3 years | |
| Secondary | Percentage of participants with drug discontinuation for any reason and due to adverse drug reactions associated with 1RPT/INH | Percentage of participants with drug discontinuation for any reason and due to adverse drug reactions associated with 1RPT/INH | up to 30 days after the last dose of study drug | |
| Secondary | Percentage of patients with Grade 3 or 4 drug toxicities and deaths associated with 1RPT/INH | Percentage of patients with Grade 3 or 4 drug toxicities and deaths associated with 1RPT/INH | up to 30 days after the last dose of study drug | |
| Secondary | Percentage of participants who complete the treatment regimen | Percentage of participants who complete the treatment regimen | Enrollment up to Month 1 (1RPT/INH) |