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

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: Latent Tuberculosis; Tuberculosis
• Intervention / Treatment: Drug: Rifampin and Isoniazid; Drug: isoniazid and rifapentine

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

• Study Contact: Name: Ruan Qiaoling, PhD; Phone Number: 13661856002; Email: ruan_qiao_ling@fudan.edu.cn
• Study Contact Backup: Name: Zhang Wenhong, PhD; Phone Number: 52888123; Email: zhangwenhong@fudan.edu.cn

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
  • Guizhou
    • 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
      • Principal Investigator: Dan Xiong
    • 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: Yan Zeng; Phone Number: 18212588909
    • 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
    • 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: Xianyan Li
      • Principal Investigator: Xianyan Li
    • 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
      • Poeple's Hospital of Leishan
      • Contact: Jikun Li
      • Principal Investigator: Jikun Li
    • 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
      • Principal Investigator: Youqian Chen
  • 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

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

How is the study designed?

Design Details

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

Number of Arms

2

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
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.	up to 24 months after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants permanently withdrawal from medication for any reason.	subjects may withdrawal from medication after serious adverse effect	up to 24 months after randomization
All-cause mortality.	subjects may withdrawal from this study because of death	up to 24 months after randomization
Number of participants with drug resistance result.	to study drug resistance condition of school TB endemic	up to 24 months after randomization
Number of participants complete the treatment.	to compare the completion rates of the two regimens	up to 24 months after randomization

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Report Outcome	health state utility and EuroQol visual analogue scale values measured by ED-5D-3L questionnaire	from baseline to 1 month after treatment

Collaborators and Investigators

• Sponsor: Huashan Hospital

Publications and helpful links

General Publications

• Ruan QL, Yang QL, Ma CL, Lin MY, Huang XT, Mao YP, Gao JM, Li JJ, Zhang XN, You ZX, Zheng QQ, Ren YF, Liu XF, Shao LY, Zhang WH. 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). Emerg Microbes Infect. 2025 Dec;14(1):2502010. doi: 10.1080/22221751.2025.2502010. Epub 2025 May 16.

Study record dates

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): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: latent tuberculosis; TPT; active screening
• Additional Relevant MeSH Terms: Latent Infection; Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis; Latent Tuberculosis; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, Fused-Ring; Polycyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Rifamycins; Lactams, Macrocyclic; Macrocyclic Compounds; Hydrazines; Isonicotinic Acids; Acids, Heterocyclic; Rifampin; Isoniazid; rifapentine
• 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