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

NCT03900858 | Unknown DMC

• 1 other identifier: 2017ZX10201302-004
• Study Type: interventional
• Target: 566
• Locations: 1 country
• Sites: 1

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.

Conditions

Silicosis Tuberculosis

Keywords

rifapentine; isoniazid; preventive

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• 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

• Percentage of participants who complete the treatment regimen

  Enrollment up to Month 1 (1RPT/INH)

Study Arms (2)

Isoniazid/ Rifapentine 3 times a week

EXPERIMENTAL

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

Drug: Isoniazid；Rifapentine

No Intervention

NO INTERVENTION

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

Interventions

Isoniazid；Rifapentine 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

Also known as: Isoniazid I INH, Rifapentine RPT, 1RPT/INH 1HP

Isoniazid/ Rifapentine 3 times a week

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Huashan Hospital: lead
• Affiliated Wenling Hospital of Wenzhou Medical University: collaborator

Study Sites (1)

Wenling No.1 People's Hospital, Zhejiang

Taizhou, Zhejiang, 317500, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 40326358 DERIVED

MeSH Terms

Interventions

rifapentine

Study Officials

• Wenhong Zhang, MD，PhD

  Huashan Hospital of Fudan University，Shanghai，China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qiaoling Ruan, MD

CONTACT

(8621)52889999; 10301010198@fudan.edu.cn

Wenhong Zhang, MD，PhD

CONTACT

(8621)52889999

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Division of Infectious Diseases

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: April 3, 2019
• Study Start: December 1, 2018
• Primary Completion: January 1, 2022
• Study Completion: June 1, 2022
• Last Updated: April 5, 2019

Record last verified: 2019-04

Locations

CN (1)