NCT03900858: TB

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

Status unknown NA Last updated 5 April 2019

What this trial tests

NA trial testing Isoniazid；Rifapentine in Silicosis Tuberculosis in 566 participants. Status unknown.

Timeline

1 December 2018

Primary endpoint
1 January 2022

1 June 2022

Quick facts

Lead sponsor	Huashan Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	566
Start date	1 December 2018
Primary completion	1 January 2022
Estimated completion	1 June 2022
Sites	1 location across China

Drugs / interventions tested

• Isoniazid；Rifapentine — full drug profile →

Conditions studied

• Silicosis Tuberculosis — all drugs for Silicosis Tuberculosis →

Sponsor

Huashan Hospital

Who can join

Adults 18 to 65, male only, with Silicosis Tuberculosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Management of Tuberculosis Infection: Current Situation, Recent Developments and Operational Challenges.
   Agbota G, Bonnet M, Lienhardt C. · · 2023 · cited 16× · PMID 36986284 · DOI 10.3390/pathogens12030362
2. <i>Mycobacterium tuberculosis</i> Infection among 1,659 Silicosis Patients in Zhejiang Province, China.
   Yang Q, Lin M, He Z, Liu X, et al · · 2022 · cited 8× · PMID 36453892 · DOI 10.1128/spectrum.01451-22
3. 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).
   Ruan QL, Yang QL, Ma CL, Lin MY, et al · · 2025 · PMID 40326358 · DOI 10.1080/22221751.2025.2502010