Clinical trial NCT03900858: Short Course Rifapentine and Isoniazid for the Preventive Treatment of Tuberculosis(SCRIPT-TB)
Official title: Short Course Rifapentine and Isoniazid for the Preventive Treatment of Tuberculosis(SCRIPT-TB)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Silicosis Tuberculosis
Keywords: rifapentine
isoniazid
preventive
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
Collaborators: name: Affiliated Wenling Hospital of Wenzhou Medical University
First posted: 2019-04-03
Enrollment: 566
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Cumulative rate of culture-confirmed or clinically diagnosed TB disease in participants
timeFrame: 3 years
Secondary outcomes:
measure: Percentage of participants with drug discontinuation for any reason and due to adverse drug reactions associated with 1RPT/INH
timeFrame: up to 30 days after the last dose of study drug
measure: Percentage of patients with Grade 3 or 4 drug toxicities and deaths associated with 1RPT/INH
timeFrame: up to 30 days after the last dose of study drug
measure: Percentage of participants who complete the treatment regimen
timeFrame: Enrollment up to Month 1 (1RPT/INH)
Other outcomes:
Locations:
city: Taizhou
country: China
facility: Wenling No.1 People's Hospital, Zhejiang
state: Zhejiang
Study officials:
affiliation: Huashan Hospital of Fudan University，Shanghai，China
name: Wenhong Zhang, MD，PhD
role: PRINCIPAL_INVESTIGATOR
References: