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TB YOUTH - TB sYstemic Management Using One-month, Ultra-short TPT Regimen for scHool Contacts (TB-YOUTH)

Primary Purpose

Tuberculosis, Latent Tuberculosis

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Rifampin and Isoniazid
isoniazid and rifapentine
Sponsored by
Huashan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tuberculosis focused on measuring latent tuberculosis, TPT, active screening

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Students of junior middle school, high school and university, age13 years old Close contact of school active tuberculosis case (e.g. in the same classroom, in the same dormitory, in the same floor) IGRA (Interferon-Gamma Release Assay) is positive and diagnosed as LTBI Himself/herself (together with his/her guardian for age under 18 years old) willing to participate in trial and sign informed consent. Exclusion Criteria: Current clinical or sputum culture confirmed active tuberculosis Had continuously taken rifamycin (rifampicin, rifapentine etc.) or isoniazid for more than 14 days in the past 2 years Have completed a full course of treatment for ATB or LTBI Allergic or intolerant to rifamycin (rifapentine or rifampicin) or isoniazid HIV (human immunodeficiency virus) antibody positive or AIDS (Acquired immunodeficiency syndrome) patients History of viral hepatitis (e.g. chronic hepatitis B, chronic hepatitis C) or liver cirrhosis Liver dysfunction (Total bilirubin > 5mg/dL (43 umol/L) or Alanine aminotransferase > 2ULN or Aspartate aminotransferase > 2ULN) or renal dysfunction Current receiving immunosuppressive therapy or biological agents Blood system diseases or Platelet count<50×10^9/L or White Blood Cell count<3.0×10^9/L Other conditions deemed unsuitable for TPT by physician.

Sites / Locations

  • Central Hospital of Jingan DistrictRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1H3P3 regimen of isoniazid and rifapentine 3 times a week for one month

3HR regimen of isoniazid and rifampicin once daily for three months

Arm Description

12-dose ultra-short TPT 1H3P3 regimen of isoniazid and rifapentine 3 times a week for one month

3HR regimen of isoniazid and rifampicin once daily for three months

Outcomes

Primary Outcome Measures

Number of participants with culture or GeneXpert MTB/RIF confirmed TB or clinically highly suggested TB
The primary aim is to estimate the effectiveness non-inferiority of 1H3P3 to 3HR.

Secondary Outcome Measures

Number of participants permanently withdrawal from medication for any reason.
subjects may withdrawal from medication after serious adverse effect
N Number of participants complete the treatment.
to compare the completion rates of the two regimens
All-cause mortality.
subjects may withdrawal from this study because of death
Number of participants with drug resistance result.
to study drug resistance condition of school TB endemic

Full Information

First Posted
March 23, 2023
Last Updated
September 25, 2023
Sponsor
Huashan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06022146
Brief Title
TB YOUTH - TB sYstemic Management Using One-month, Ultra-short TPT Regimen for scHool Contacts
Acronym
TB-YOUTH
Official Title
TB YOUTH - TB sYstemic Management Using One-month, Ultra-short TPT Regimen for scHool Contacts
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
September 1, 2026 (Anticipated)
Study Completion Date
September 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huashan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This is a prospective, multi-center, open-label, cluster randomized controlled clinical trial conducted in school settings to estimate the non-inferiority effect of 1H3P3 compared with 3HR.
Detailed Description
Background: Adolescents are susceptible to tuberculosis. Almost 1.1 million children (aged below 15 years) and another half a million older adolescents (15-19 years) become ill with TB every year. Approximately 5%-10% people infected with TB develop to active disease, which suggest that a great proportion of adolescents remain undiagnosed and unprotected. Undiagnosed cases and school-based transmission contribute to the burden of TB among adolescents. Closing the gap in targeted interventions for TB prevention in schools is essential to break the cycle of transmission and ensure the well-being of school-aged adolescents. However, TB preventive treatment targeted on adolescents are still lacking. Method: This is a prospective, multicenter, open-label, non-inferiority, cluster randomized controlled clinical trial within the national tuberculosis control program of GuiZhou,China. Close contacts of school tuberculosis index cases are actively screened with QFT(QuantiFERON-TB Gold Plus), chest X-ray, pooled GeneXpert MTB/RIF test of sputum and symptoms. After ruling out active tuberculosis, LTBI students are enrolled to attend a non-inferiority, cluster randomized controlled clinical trial. The students will be given either 3HR or 1H3P3 regimen and followed for two years. Our primary endpoint is culture or GeneXpert MTB/RIF confirmed TB or clinically highly suggested TB. Assume ICC (interclass correlation coefficient) to be 0.05, the study will need 1658 subjects per arm to provide 80% power to detect a 20% non-inferiority margin of primary endpoint between the two arms. Discussion: The effectiveness of contact investigation among adolescent students as a tool for improved tuberculosis control has not been established. The integration of ultra-short treatment regimens with active screening holds the potential to provide a comprehensive and effective strategy for tuberculosis prevention and control in school environments, which may help reform the national tuberculosis policy regarding adolescent TB.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis, Latent Tuberculosis
Keywords
latent tuberculosis, TPT, active screening

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3316 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1H3P3 regimen of isoniazid and rifapentine 3 times a week for one month
Arm Type
Experimental
Arm Description
12-dose ultra-short TPT 1H3P3 regimen of isoniazid and rifapentine 3 times a week for one month
Arm Title
3HR regimen of isoniazid and rifampicin once daily for three months
Arm Type
Active Comparator
Arm Description
3HR regimen of isoniazid and rifampicin once daily for three months
Intervention Type
Drug
Intervention Name(s)
Rifampin and Isoniazid
Intervention Description
3HR regimen of isoniazid and rifampicin once daily for three months
Intervention Type
Drug
Intervention Name(s)
isoniazid and rifapentine
Intervention Description
12-dose ultra-short TPT 1H3P3 regimen of isoniazid and rifapentine 3 times a week for one month
Primary Outcome Measure Information:
Title
Number of participants with culture or GeneXpert MTB/RIF confirmed TB or clinically highly suggested TB
Description
The primary aim is to estimate the effectiveness non-inferiority of 1H3P3 to 3HR.
Time Frame
up to 24 months after treatment
Secondary Outcome Measure Information:
Title
Number of participants permanently withdrawal from medication for any reason.
Description
subjects may withdrawal from medication after serious adverse effect
Time Frame
up to 24 months after treatment
Title
N Number of participants complete the treatment.
Description
to compare the completion rates of the two regimens
Time Frame
up to 24 months after treatment
Title
All-cause mortality.
Description
subjects may withdrawal from this study because of death
Time Frame
up to 24 months after treatment
Title
Number of participants with drug resistance result.
Description
to study drug resistance condition of school TB endemic
Time Frame
up to 24 months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Students of junior middle school, high school and university, age13 years old Close contact of school active tuberculosis case (e.g. in the same classroom, in the same dormitory, in the same floor) IGRA (Interferon-Gamma Release Assay) is positive and diagnosed as LTBI Himself/herself (together with his/her guardian for age under 18 years old) willing to participate in trial and sign informed consent. Exclusion Criteria: Current clinical or sputum culture confirmed active tuberculosis Had continuously taken rifamycin (rifampicin, rifapentine etc.) or isoniazid for more than 14 days in the past 2 years Have completed a full course of treatment for ATB or LTBI Allergic or intolerant to rifamycin (rifapentine or rifampicin) or isoniazid HIV (human immunodeficiency virus) antibody positive or AIDS (Acquired immunodeficiency syndrome) patients History of viral hepatitis (e.g. chronic hepatitis B, chronic hepatitis C) or liver cirrhosis Liver dysfunction (Total bilirubin > 5mg/dL (43 umol/L) or Alanine aminotransferase > 2ULN or Aspartate aminotransferase > 2ULN) or renal dysfunction Current receiving immunosuppressive therapy or biological agents Blood system diseases or Platelet count<50×10^9/L or White Blood Cell count<3.0×10^9/L Other conditions deemed unsuitable for TPT by physician.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ruan Qiaoling, PhD
Phone
13661856002
Email
ruan_qiao_ling@fudan.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Zhang Wenhong, PhD
Phone
52888123
Email
zhangwenhong@fudan.edu.cn
Facility Information:
Facility Name
Central Hospital of Jingan District
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenhong Zhang, Prof
Phone
021-61578000

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
This research targets adolescent students in school. We decide not to share IPD from the ethical perspective.

Learn more about this trial

TB YOUTH - TB sYstemic Management Using One-month, Ultra-short TPT Regimen for scHool Contacts

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