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

NCT ID: NCT03900858

Last Updated: 2019-04-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 566 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2022-06-01

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.

Conditions

Silicosis Tuberculosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Isoniazid/ Rifapentine 3 times a week

Intervention：Isoniazid/ Rifapentine 3 times a week given by DOT oral Rifapentine (450mg) plus Isoniazid (400mg) for 12 doses

Group Type: EXPERIMENTAL

Isoniazid；Rifapentine

Intervention Type: DRUG

1 months (12 doses) of three-weekly rifapentine at a dose of 450mg plus isoniazid at a dose of 400mg given under direct observation

No Intervention

No preventive treatment Follow up without intervention. Have already done.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Isoniazid；Rifapentine

1 months (12 doses) of three-weekly rifapentine at a dose of 450mg plus isoniazid at a dose of 400mg given under direct observation

Intervention Type: DRUG

Other Intervention Names

Isoniazid I INH; Rifapentine RPT; 1RPT/INH 1HP

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Affiliated Wenling Hospital of Wenzhou Medical University

OTHER

Sponsor Role: collaborator

Huashan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wen-hong Zhang

Director of Division of Infectious Diseases

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wenhong Zhang, MD，PhD

Role: PRINCIPAL_INVESTIGATOR

Huashan Hospital of Fudan University，Shanghai，China

Locations

Wenling No.1 People's Hospital, Zhejiang

Taizhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qiaoling Ruan, MD

Role: CONTACT

10301010198@fudan.edu.cn

(8621)52889999 ext. 8123

Wenhong Zhang, MD，PhD

Role: CONTACT

(8621)52889999 ext. 8123

Facility Contacts

Miaoyao Ling, MD

Role: primary

lmy120904@sina.com

+86576-89668099

References

Ruan QL, Yang QL, Ma CL, Lin MY, Huang XT, Mao YP, Gao JM, Li JJ, Zhang XN, You ZX, Zheng QQ, Ren YF, Liu XF, Shao LY, Zhang WH. Efficacy and safety of a novel short course rifapentine and isoniazid regimen for the preventive treatment of tuberculosis in Chinese silicosis patients: a pilot study (SCRIPT-TB). Emerg Microbes Infect. 2025 Dec;14(1):2502010. doi: 10.1080/22221751.2025.2502010. Epub 2025 May 16.

Reference Type: DERIVED

PMID: 40326358 (View on PubMed)

Other Identifiers

2017ZX10201302-004

Identifier Type: -

Identifier Source: org_study_id