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

April 3, 2019 updated by: Wen-hong Zhang, Huashan Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

566

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Taizhou, Zhejiang, China, 317500
        • Recruiting
        • Wenling No.1 People's Hospital, Zhejiang
        • Contact:
        • Sub-Investigator:
          • Xitian Huang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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
Other Names:
  • Isoniazid I INH
  • Rifapentine RPT
  • 1RPT/INH 1HP
No Intervention: No Intervention
No preventive treatment Follow up without intervention. Have already done.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative rate of culture-confirmed or clinically diagnosed TB disease in participants
Time Frame: 3 years
Cumulative rate of culture-confirmed or clinically diagnosed TB disease in participants
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants with drug discontinuation for any reason and due to adverse drug reactions associated with 1RPT/INH
Time Frame: up to 30 days after the last dose of study drug
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
Time Frame: 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
Time Frame: Enrollment up to Month 1 (1RPT/INH)
Percentage of participants who complete the treatment regimen
Enrollment up to Month 1 (1RPT/INH)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huashan Hospital

Collaborators

Wenling No.1 People's Hospital, China

Investigators

  • Principal Investigator: Wenhong Zhang, MD，PhD, Huashan Hospital of Fudan University，Shanghai，China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2018

Primary Completion (Anticipated)

January 1, 2022

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

April 1, 2019

First Submitted That Met QC Criteria

April 1, 2019

First Posted (Actual)

April 3, 2019

Study Record Updates

Last Update Posted (Actual)

April 5, 2019

Last Update Submitted That Met QC Criteria

April 3, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017ZX10201302-004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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