A Novel Therapy With a 1-Month Ultrashort Regimen to Halt Progression From Latent Infection to Active Tuberculosis Among Close Contacts (The TB-YOUTH Study) (TB-YOUTH)

July 13, 2026 updated by: Wen-hong Zhang, Huashan Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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, and the the lost to follow-up rate is 10%, the study will need 1760 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.

Study Type

Interventional

Enrollment (Estimated)

3520

Phase

  • Phase 3

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • China
      • Bijie, China
        • Recruiting
        • 3rd People's Hospital of Bijie
        • Contact:
          • Lijuan Lin
        • Principal Investigator:
          • Lijuan Lin
      • Bijie, China
        • Recruiting
        • People's Hospital of Dafang Town
        • Contact:
          • Zhengjie Jiang
        • Principal Investigator:
          • Dan Ding
      • Bijie, China
        • Recruiting
        • People's Hospital of Nayong
        • Contact:
          • Qili Liu
        • Principal Investigator:
          • Qili Liu
      • Guiyang, China
        • Recruiting
        • Chinese Medicine Hospital of Qingzhen
        • Contact:
          • Jie Yang
        • Principal Investigator:
          • Jie Yang
      • Qiandongnan Miao and Dong Autonomous Region, China
        • Recruiting
        • People's Hospital of Majiang
        • Contact:
          • Jiangjiang Li
          • Phone Number: 13885553585
        • Contact:
          • Yiwu Li
        • Principal Investigator:
          • Yiwu Li
      • Qiandongnan Miao and Dong Autonomous Region, China
        • Recruiting
        • People's Hospital of Taijiang
        • Contact:
          • Jian Tai
        • Principal Investigator:
          • Jian Tai
      • Qiannan, China
        • Recruiting
        • People's Hospital of Changshun
        • Contact:
          • Changna Yang
          • Phone Number: +86 18744755490
    • Guiyang
      • Anshun, Guiyang, China
        • Recruiting
        • People's Hospital of Ziyun
        • Contact:
          • Zhengli Guo
          • Phone Number: +86 13985357572
    • Guizhou
      • Anshun, Guizhou, China
        • Recruiting
        • People's Hospital of Guanling
        • Contact:
          • Enyan Zhang
          • Phone Number: +86 18798039844
      • Anshun, Guizhou, China
        • Recruiting
        • People's Hospital of Pingba District
        • Contact:
          • Jinrong Wu
          • Phone Number: +86 13885332699
      • Anshun, Guizhou, China
        • Recruiting
        • People's Hospital of Puding
        • Contact:
          • Lei Liu
          • Phone Number: +86 15186613668
      • Anshun, Guizhou, China
        • Recruiting
        • People's Hospital of Xixiu District
        • Contact:
          • Jiali Wang
          • Phone Number: +86 13765361818
      • Anshun, Guizhou, China
        • Recruiting
        • People's Hospital of Zhenning
        • Contact:
          • Min Zhang
          • Phone Number: +86 18085307558
      • Bijie, Guizhou, China
        • Recruiting
        • People's Hospital of Hezhang
        • Contact:
          • Qian He
        • Principal Investigator:
          • Qian He
      • Bijie, Guizhou, China
        • Recruiting
        • People's Hospital of Qianxi
        • Contact:
          • Dan Xiong
          • Phone Number: +86 15085748336
      • Bijie, Guizhou, China
        • Recruiting
        • People's Hospital of Weining
        • Contact:
          • Yongbi Wang
        • Principal Investigator:
          • Yongbi Wang
      • Bijie, Guizhou, China
        • Recruiting
        • People's Hospital of Zhijin
        • Contact:
          • Tinggui Liu
        • Principal Investigator:
          • Tinggui Liu
      • Daozhen Klau and Hmong Autonomous County in Zun'yi, Guizhou, China
        • Recruiting
        • People's Hospital of Daozhen Klau and Hmong autonomous county
        • Contact:
          • Donghui Han
          • Phone Number: +86 13708506359
        • Principal Investigator:
          • Donghui Han
      • Guiyang, Guizhou, China
        • Recruiting
        • Guiyang Public Health Treatment Center
        • Contact:
          • Zhongfeng Huang
          • Phone Number: +86 13984308233
      • Guiyang, Guizhou, China
        • Recruiting
        • People's Hospital of Baiyun District
        • Contact:
          • Fengxiang Yang
          • Phone Number: +86 13639014358
      • Guiyang, Guizhou, China
        • Recruiting
        • People's Hospital of Huaxi District
        • Contact:
          • Dan Liu
          • Phone Number: +86 18096179686
      • Guiyang, Guizhou, China
        • Recruiting
        • People's Hospital of Kaiyang
        • Contact:
          • Jiye Wang
          • Phone Number: +86 13608525056
      • Guiyang, Guizhou, China
        • Recruiting
        • People's Hospital of Wudang District
        • Contact:
          • Xiaoju Wu
          • Phone Number: +86 18585836405
      • Guiyang, Guizhou, China
        • Recruiting
        • People's Hospital of Xifeng
        • Contact:
          • Xia Zhou
          • Phone Number: +86 13984879290
      • Guiyang, Guizhou, China
        • Recruiting
        • People's Hospital of Xiuwen
        • Contact:
          • Rongsong Ling
          • Phone Number: +86 13595098202
      • Liupanshui, Guizhou, China
        • Recruiting
        • Liuzhi Special District
        • Contact:
          • Ning Wang
        • Principal Investigator:
          • Ning Wang
      • Liupanshui, Guizhou, China
        • Recruiting
        • People's Hospital of Panzhou
        • Contact:
          • Hui Zhang
        • Principal Investigator:
          • Hui Zhang
      • Liupanshui, Guizhou, China
        • Recruiting
        • People's Hospital of Shuicheng District, Liupanshui City
        • Contact:
          • Dan Xiong
        • Principal Investigator:
          • Dan Xiong
      • Liupanshui, Guizhou, China
        • Recruiting
        • Second People's Hospital of Liupanshui City
        • Contact:
          • Benli Li
        • Principal Investigator:
          • Benli Li
      • Liupanshui, Guizhou, China
        • Recruiting
        • Third People's Hospital of Liupanshui
        • Contact:
          • Xiaohong Guo
          • Phone Number: +86 13688588822
        • Principal Investigator:
          • Xiaohong Guo
      • Qiandongnan Miao and Dong Autonomous Prefecture, Guizhou, China
        • Recruiting
        • People's Hospital of Cengong
        • Contact:
          • Zhongfeng Wang
          • Phone Number: +86 13648550826
        • Principal Investigator:
          • Zhongfeng Wang
      • Qiandongnan Miao and Dong Autonomous Prefecture, Guizhou, China
        • Recruiting
        • People's Hospital of Congjiang
        • Contact:
          • Phone Number: +86 13595589309
        • Principal Investigator:
          • Yuequn Yang
      • Qiandongnan Miao and Dong Autonomous Region, Guizhou, China
        • Recruiting
        • First People's Hospital of Kaili
        • Contact:
          • Hongzhi Luo
        • Principal Investigator:
          • Hongzhi Luo
      • Qiandongnan Miao and Dong Autonomous Region, Guizhou, China
        • Recruiting
        • People's Hospital of Danzhai
        • Contact:
          • Fang Yang
        • Principal Investigator:
          • Fang Yang
      • Qiandongnan Miao and Dong Autonomous Region, Guizhou, China
        • Recruiting
        • People's Hospital of Huangping
        • Principal Investigator:
          • Yan Zhang
        • Contact:
          • Yan Zhang
      • Qiandongnan Miao and Dong Autonomous Region, Guizhou, China
        • Recruiting
        • People's Hospital of Jianhe
        • Contact:
          • Jiaze Long
        • Principal Investigator:
          • Jiaze Long
      • Qiandongnan Miao and Dong Autonomous Region, Guizhou, China
        • Recruiting
        • People's Hospital of Jinping
        • Contact:
          • Yunjun Cao
        • Principal Investigator:
          • Yunjun Cao
      • Qiandongnan Miao and Dong Autonomous Region, Guizhou, China
        • Recruiting
        • People's Hospital of Liping
        • Contact:
          • Sihui Ma
        • Principal Investigator:
          • Sihui Ma
      • Qiandongnan Miao and Dong Autonomous Region, Guizhou, China
        • Recruiting
        • People's Hospital of Rongjiang
        • Contact:
          • Zongqing Yang
        • Principal Investigator:
          • Zongqing Yang
      • Qiandongnan Miao and Dong Autonomous Region, Guizhou, China
        • Recruiting
        • People's Hospital of Sansui
        • Contact:
          • Jinjun Wan
        • Principal Investigator:
          • Jinjun Wan
      • Qiandongnan Miao and Dong Autonomous Region, Guizhou, China
        • Recruiting
        • People's Hospital of Shibing
        • Contact:
          • Xiankang Luo
        • Principal Investigator:
          • Xiankang Luo
      • Qiandongnan Miao and Dong Autonomous Region, Guizhou, China
        • Recruiting
        • People's Hospital of Tianzhu
        • Contact:
          • Caijin Liu
        • Principal Investigator:
          • Caijin Liu
      • Qiandongnan Miao and Dong Autonomous Region, Guizhou, China
        • Recruiting
        • People's Hospital of Zhenyuan
        • Contact:
          • Zhenqing Wu
        • Principal Investigator:
          • Zhenqing Wu
      • Qiandongnan Miao and Dong Autonomous Region, Guizhou, China
        • Recruiting
        • People's Hospital of Leishan
        • Contact:
          • Jikun Li
        • Principal Investigator:
          • Jikun Li
      • Qiannan, Guizhou, China
        • Recruiting
        • First People's Hospital of Fuquan
        • Contact:
          • Shaoqin Zhai
          • Phone Number: +86 15121399655
      • Qiannan, Guizhou, China
        • Recruiting
        • People's Hospital of Libo
        • Contact:
          • Fengtian He
          • Phone Number: +86 13765438947
      • Qiannan, Guizhou, China
        • Recruiting
        • People's Hospital of Luodian
        • Contact:
          • Tian Tian
          • Phone Number: +86 18188045662
      • Tongren, Guizhou, China
        • Recruiting
        • People's Hospital of Wanshan District
        • Contact:
          • Chunying Yan
          • Phone Number: +86 18984654371
      • Zunyi, Guizhou, China
        • Recruiting
        • Guizhou Aerospace Hospital
        • Contact:
          • Guifeng Li
        • Principal Investigator:
          • Guifeng Li
      • Zunyi, Guizhou, China
        • Recruiting
        • People's Hospital of Bozhou District
        • Contact:
          • Jianfang Yuan
        • Principal Investigator:
          • Jianfang Yuan
      • Zunyi, Guizhou, China
        • Recruiting
        • People's Hospital of Chishui
        • Contact:
          • Di Hu
          • Phone Number: +86 18683066066
        • Principal Investigator:
          • Minghui Nie
      • Zunyi, Guizhou, China
        • Recruiting
        • People's Hospital of Fenggang
        • Contact:
          • Xuan Luo
          • Phone Number: +86 13096776678
        • Principal Investigator:
          • Xuan Luo
      • Zunyi, Guizhou, China
        • Recruiting
        • People's Hospital of Honghuagang District
        • Contact:
          • Yunhe Gong
        • Principal Investigator:
          • Yunhe Gong
      • Zunyi, Guizhou, China
        • Recruiting
        • People's Hospital of Meitan
        • Principal Investigator:
          • Bin Guo
      • Zunyi, Guizhou, China
        • Recruiting
        • People's Hospital of Renhuai
        • Contact:
          • Yongming Cai
        • Principal Investigator:
          • Yongming Cai
      • Zunyi, Guizhou, China
        • Recruiting
        • People's Hospital of Suiyang
        • Contact:
          • Anze Chen
        • Principal Investigator:
          • Anze Chen
      • Zunyi, Guizhou, China
        • Recruiting
        • People's Hospital of Tongzi
        • Contact:
          • Nian Wang
        • Principal Investigator:
          • Nian Wang
      • Zunyi, Guizhou, China
        • Recruiting
        • People's Hospital of Wuchuan Klau and Hmong autonomous county
        • Contact:
          • Shijiang Tian
        • Principal Investigator:
          • Shijiang Tian
      • Zunyi, Guizhou, China
        • Recruiting
        • People's Hospital of Xishui
        • Contact:
          • Qianshu Zhao
        • Principal Investigator:
          • Qianshu Zhao
      • Zunyi, Guizhou, China
        • Recruiting
        • People's Hospital of Yuqing
        • Contact:
          • Ya Zeng
        • Principal Investigator:
          • Ya Zeng
      • Zunyi, Guizhou, China
        • Recruiting
        • People's Hospital of Zhengan
        • Contact:
          • Yun Zhan
        • Principal Investigator:
          • Yun Zhan
      • Zunyi, Guizhou, China
        • Recruiting
        • Zunyi Infectious Disease Hospital
        • Contact:
          • Youqian Chen
          • Phone Number: +86 15870102934
    • Liaoning
      • Dalian, Liaoning, China
        • Recruiting
        • Dalian Public Health Clinical Center
        • Contact:
          • Xu Cao, MD
          • Phone Number: 18018918131
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200040
        • Recruiting
        • Huashan Hospital
        • Contact:
          • Qiaoling Ruan, MD, PhD
          • Phone Number: 021-61578000
        • Principal Investigator:
          • Wenhong Zhang, MD, PhD
        • Sub-Investigator:
          • Qiaoling Ruan, 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Aged ≥13 years and body weight ≥ 30 kg;

  2. School-registered individuals including:

    • Currently attending junior / senior high school or university students;
    • School staff members;

  3. Close contacts of active pulmonary TB index cases (confirmed or clinically diagnosed) within the school, defined by meeting both of the following:

    • Teachers/students sharing the same classroom or dormitory with the index case;
    • Exposure history: Prolonged sharing of enclosed space (>4 hours total within 1 week) with the index case;
  4. Confirmed LTBI status through screening;
  5. Voluntary participation with signed informed consent form (for adults ≥18 years);
  6. Parental / guardian consent and co-signed informed consent form (for minors aged 13-17 years).

Exclusion Criteria:

  1. Current active TB disease (clinically or bacteriologically confirmed);
  2. Documented isoniazid/rifampicin resistance in the corresponding M. tuberculosis strain from the index case;
  3. Self-reported use of rifamycins (e.g., rifampicin, rifapentine) or isoniazid for >14 consecutive days within the past 2 years;
  4. Prior completion of full-course of treatment for ATB or LTBI;
  5. Hypersensitivity or intolerance to rifamycins (rifapentine / rifampicin) or isoniazid;
  6. HIV positive serostatus or AIDS patients;
  7. History of viral hepatitis (e.g., chronic hepatitis B, chronic hepatitis C) or liver cirrhosis;
  8. Liver dysfunction (TBil>2.5mg/dL [43umol/L] or ALT / AST>2ULN) or renal dysfunction.
  9. Current receiving immunosuppressive therapy or biological agents.
  10. Hematologic disorders with either PLT<50×109/L or WBC<3.0×109/L.
  11. Other conditions deemed unsuitable for TPT by investigators.

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: 1H3P3 regimen of isoniazid and rifapentine 3 times a week for one month
12-dose ultra-short TPT 1H3P3 regimen of isoniazid and rifapentine 3 times a week for one month
Drug: isoniazid and rifapentine
12-dose ultra-short TPT 1H3P3 regimen of isoniazid and rifapentine 3 times a week for 4 weeks
Other Names:
  • 1H3P3
Active Comparator: 3HR regimen of isoniazid and rifampicin once daily for three months
Drug: Rifampin and Isoniazid
3HR regimen of isoniazid and rifampicin once daily for three months
Other Names:
  • 3HR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative incidence of active tuberculosis (TB) over 24 months
Time Frame: up to 24 months after randomization
The primary endpoint is a composite of bacteriologically confirmed or clinically diagnosed active TB within 24 months after randomization. Bacteriologically confirmed TB is defined as M. tuberculosis detection by sputum culture and/or molecular assay (e.g., GeneXpert MTB/RIF). Clinically diagnosed TB requires the presence of ≥2 objective clinical symptoms (cough ≥2 weeks, fever, night sweats, weight loss >10%, or hemoptysis) plus chest imaging findings highly suggestive of active TB, after exclusion of alternative diagnoses. This measure will be used to assess the non-inferiority of the 1H3P3 regimen compared to the 3HR regimen.
up to 24 months after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants with adverse events (AEs) and serious adverse events (SAEs)
Time Frame: from first dose to one month after treatment completion
To compare the safety profiles between the 1H3P3 and 3HR regimens. All AEs and SAEs will be documented, and group differences in AE proportions will be analyzed. Severity will be graded per the Division of AIDS (DAIDS) table.
from first dose to one month after treatment completion
Incidence of treatment discontinuation attributable to AEs
Time Frame: During the treatment course period (up to 1 month for 1H3P3 arm and up to 3 months for 3HR arm).
To compare the treatment discontinuation rates due to AEs between the 1H3P3 and 3HR regimens
During the treatment course period (up to 1 month for 1H3P3 arm and up to 3 months for 3HR arm).
Treatment completion rate.
Time Frame: up to 16 weeks from randomization
Defined as the proportion of participants who complete ≥90% of scheduled doses within 110% of the planned treatment duration (≥11 doses within 6 weeks for 1H3P3 group and ≥81 doses within 16 weeks for 3HR group)
up to 16 weeks from randomization
All-cause mortality.
Time Frame: up to 24 months after randomization
Death from any cause during the 24-month follow-up period.
up to 24 months after randomization
Acquired drug resistance
Time Frame: At time of active TB diagnosis, up to 24 months post-randomization.
The proportion of participants who develop active TB post-TPT and whose M. tuberculosis isolate shows resistance to isoniazid, rifampicin, or rifapentine by drug susceptibility testing or targeted molecular assays.
At time of active TB diagnosis, up to 24 months post-randomization.
2-year cumulative incidence of active TB in the non-intervention cohort
Time Frame: From enrollment up to 24 months.
To establish the background incidence of active TB among high-risk LTBI individuals who declined TPT, and to quantify the risk reduction rate (protective efficacy) of the 1H3P3 and 3HR regimens relative to this non-intervention cohort. Risk reduction rate = 1-(intervention group incidence / nonintervention group incidence)
From enrollment up to 24 months.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-Reported Outcome (PRO) - Health-related Quality of Life (Exploratory)
Time Frame: From baseline up to 1 month post-treatment completion
Health state utility and EuroQol visual analogue scale (EQ VAS) values will be measured using the EuroQol 5-Dimensions 3-Level (EQ-5D-3L) questionnaire. This exploratory endpoint was introduced via a protocol amendment and will be administered only to participants enrolled after the amendment effective date. Assessments occur at baseline and at each on-treatment visit.
From baseline up to 1 month post-treatment completion

Collaborators and Investigators

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

Sponsor

Huashan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

September 1, 2023

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

March 23, 2023

First Submitted That Met QC Criteria

August 28, 2023

First Posted (Actual)

September 1, 2023

Study Record Updates

Last Update Posted (Actual)

July 14, 2026

Last Update Submitted That Met QC Criteria

July 13, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TB-YOUTH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This research targets adolescent students in school. We decide not to share IPD from the ethical perspective.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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