MedTrace Logo

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

NCT03900858 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 566

Last updated 2019-04-05

No results posted yet for this study

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

Interventions

DRUG

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

Sponsors & Collaborators

  • Affiliated Wenling Hospital of Wenzhou Medical University

    collaborator OTHER

  • Huashan Hospital

    lead OTHER

Principal Investigators

  • Wenhong Zhang, MD，PhD · Huashan Hospital of Fudan University，Shanghai，China

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-01
Primary Completion
2022-01-01
Completion
2022-06-01

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03900858 on ClinicalTrials.gov