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TuberculosisPhase 3TB-YOUTHNCT06022146

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)

A Phase 3 study testing isoniazid and rifapentine and Rifampin and Isoniazid in people with Tuberculosis and Latent Tuberculosis, run by Huashan Hospital at 66 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 13 years and older
Conditions the study is for
Tuberculosis, Latent Tuberculosis
What is being tested?
isoniazid and rifapentine and Rifampin and Isoniazid
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,520 participants
Where
66 sitesChina
Study dates
1 Sep 2023to 1 Sep 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Aged ≥13 years and body weight ≥ 30 kg;
  • School-registered individuals including:
  • Currently attending junior / senior high school or university students;
  • School staff members;
  • 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;
Show all 10Show fewer
  • Exposure history: Prolonged sharing of enclosed space (>4 hours total within 1 week) with the index case;
  • Confirmed LTBI status through screening;
  • Voluntary participation with signed informed consent form (for adults ≥18 years);
  • Parental / guardian consent and co-signed informed consent form (for minors aged 13-17 years).

Who cannot join

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

Trial locations and contacts

66 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Ruan Qiaoling, PhD contact

13661856002

ruan_qiao_ling@fudan.edu.cn

Zhang Wenhong, PhD contact

52888123

zhangwenhong@fudan.edu.cn

66 sites in 1 country

China66 sites, 66 recruiting

  • People's Hospital of Ziyun

    Anshun, Guiyang

    Zhengli Guo, +86 13985357572

    Recruiting

  • People's Hospital of Guanling

    Anshun, Guizhou

    Enyan Zhang, +86 18798039844

    Recruiting

  • People's Hospital of Pingba District

    Anshun, Guizhou

    Jinrong Wu, +86 13885332699

    Recruiting

  • People's Hospital of Puding

    Anshun, Guizhou

    Lei Liu, +86 15186613668

    Recruiting

  • People's Hospital of Xixiu District

    Anshun, Guizhou

    Jiali Wang, +86 13765361818

    Recruiting

  • People's Hospital of Zhenning

    Anshun, Guizhou

    Min Zhang, +86 18085307558

    Recruiting

  • People's Hospital of Hezhang

    Bijie, Guizhou

    Qian He

    Qian He

    Recruiting

  • People's Hospital of Qianxi

    Bijie, Guizhou

    Dan Xiong

    Dan Xiong

    Recruiting

  • People's Hospital of Qianxi

    Bijie, Guizhou

    Dan Xiong, +86 15085748336

    Recruiting

  • People's Hospital of Weining

    Bijie, Guizhou

    Yongbi Wang

    Yongbi Wang

    Recruiting

  • People's Hospital of Zhijin

    Bijie, Guizhou

    Tinggui Liu

    Tinggui Liu

    Recruiting

  • 3rd People's Hospital of Bijie

    Bijie

    Lijuan Lin

    Lijuan Lin

    Recruiting

  • People's Hospital of Dafang Town

    Bijie

    Zhengjie Jiang

    Dan Ding

    Recruiting

  • People's Hospital of Nayong

    Bijie

    Qili Liu

    Qili Liu

    Recruiting

  • Dalian Public Health Clinical Center

    Dalian, Liaoning

    Xu Cao, MD, 18018918131

    Recruiting

  • People's Hospital of Daozhen Klau and Hmong autonomous county

    Daozhen Klau and Hmong Autonomous County in Zun'yi, Guizhou

    Donghui Han, +86 13708506359

    Donghui Han

    Recruiting

  • Guiyang Public Health Treatment Center

    Guiyang, Guizhou

    Zhongfeng Huang, +86 13984308233

    Recruiting

  • People's Hospital of Baiyun District

    Guiyang, Guizhou

    Fengxiang Yang, +86 13639014358

    Recruiting

  • People's Hospital of Huaxi District

    Guiyang, Guizhou

    Dan Liu, +86 18096179686

    Recruiting

  • People's Hospital of Kaiyang

    Guiyang, Guizhou

    Jiye Wang, +86 13608525056

    Recruiting

  • People's Hospital of Wudang District

    Guiyang, Guizhou

    Xiaoju Wu, +86 18585836405

    Recruiting

  • People's Hospital of Xifeng

    Guiyang, Guizhou

    Xia Zhou, +86 13984879290

    Recruiting

  • People's Hospital of Xiuwen

    Guiyang, Guizhou

    Rongsong Ling, +86 13595098202

    Recruiting

  • Chinese Medicine Hospital of Qingzhen

    Guiyang

    Jie Yang

    Jie Yang

    Recruiting

  • Liuzhi Special District

    Liupanshui, Guizhou

    Ning Wang

    Ning Wang

    Recruiting

  • People's Hospital of Panzhou

    Liupanshui, Guizhou

    Hui Zhang

    Hui Zhang

    Recruiting

  • People's Hospital of Shuicheng District, Liupanshui City

    Liupanshui, Guizhou

    Dan Xiong

    Dan Xiong

    Recruiting

  • Second People's Hospital of Liupanshui City

    Liupanshui, Guizhou

    Benli Li

    Benli Li

    Recruiting

  • Third People's Hospital of Liupanshui

    Liupanshui, Guizhou

    Xiaohong Guo, +86 13688588822

    Xiaohong Guo

    Recruiting

  • People's Hospital of Cengong

    Qiandongnan Miao and Dong Autonomous Prefecture, Guizhou

    Zhongfeng Wang, +86 13648550826

    Zhongfeng Wang

    Recruiting

  • People's Hospital of Congjiang

    Qiandongnan Miao and Dong Autonomous Prefecture, Guizhou

    +86 13595589309

    Yuequn Yang

    Recruiting

  • First People's Hospital of Kaili

    Qiandongnan Miao and Dong Autonomous Region, Guizhou

    Hongzhi Luo

    Hongzhi Luo

    Recruiting

  • People's Hospital of Danzhai

    Qiandongnan Miao and Dong Autonomous Region, Guizhou

    Fang Yang

    Fang Yang

    Recruiting

  • People's Hospital of Huangping

    Qiandongnan Miao and Dong Autonomous Region, Guizhou

    Yan Zhang

    Yan Zhang

    Recruiting

  • People's Hospital of Jianhe

    Qiandongnan Miao and Dong Autonomous Region, Guizhou

    Jiaze Long

    Jiaze Long

    Recruiting

  • People's Hospital of Jinping

    Qiandongnan Miao and Dong Autonomous Region, Guizhou

    Yunjun Cao

    Yunjun Cao

    Recruiting

  • People's Hospital of Leishan

    Qiandongnan Miao and Dong Autonomous Region, Guizhou

    Jikun Li

    Jikun Li

    Recruiting

  • People's Hospital of Liping

    Qiandongnan Miao and Dong Autonomous Region, Guizhou

    Sihui Ma

    Sihui Ma

    Recruiting

  • People's Hospital of Rongjiang

    Qiandongnan Miao and Dong Autonomous Region, Guizhou

    Zongqing Yang

    Zongqing Yang

    Recruiting

  • People's Hospital of Sansui

    Qiandongnan Miao and Dong Autonomous Region, Guizhou

    Jinjun Wan

    Jinjun Wan

    Recruiting

  • People's Hospital of Shibing

    Qiandongnan Miao and Dong Autonomous Region, Guizhou

    Xiankang Luo

    Xiankang Luo

    Recruiting

  • People's Hospital of Tianzhu

    Qiandongnan Miao and Dong Autonomous Region, Guizhou

    Caijin Liu

    Caijin Liu

    Recruiting

  • People's Hospital of Zhenyuan

    Qiandongnan Miao and Dong Autonomous Region, Guizhou

    Zhenqing Wu

    Zhenqing Wu

    Recruiting

  • People's Hospital of Majiang

    Qiandongnan Miao and Dong Autonomous Region

    Jiangjiang Li, 13885553585

    Yiwu Li

    Recruiting

  • People's Hospital of Taijiang

    Qiandongnan Miao and Dong Autonomous Region

    Jian Tai

    Jian Tai

    Recruiting

  • First People's Hospital of Fuquan

    Qiannan, Guizhou

    Shaoqin Zhai, +86 15121399655

    Recruiting

  • People's Hospital of Libo

    Qiannan, Guizhou

    Fengtian He, +86 13765438947

    Recruiting

  • People's Hospital of Luodian

    Qiannan, Guizhou

    Tian Tian, +86 18188045662

    Recruiting

  • People's Hospital of Changshun

    Qiannan

    Changna Yang, +86 18744755490

    Recruiting

  • Huashan Hospital

    Shanghai, Shanghai Municipality, 200040

    Qiaoling Ruan, MD, PhD, 021-61578000

    Wenhong Zhang, MD, PhD

    Recruiting

  • People's Hospital of Wanshan District

    Tongren, Guizhou

    Chunying Yan, +86 18984654371

    Recruiting

  • Guizhou Aerospace Hospital

    Zunyi, Guizhou

    Guifeng Li

    Guifeng Li

    Recruiting

  • People's Hospital of Bozhou District

    Zunyi, Guizhou

    Jianfang Yuan

    Jianfang Yuan

    Recruiting

  • People's Hospital of Chishui

    Zunyi, Guizhou

    Di Hu, +86 18683066066

    Minghui Nie

    Recruiting

  • People's Hospital of Fenggang

    Zunyi, Guizhou

    Xuan Luo, +86 13096776678

    Xuan Luo

    Recruiting

  • People's Hospital of Honghuagang District

    Zunyi, Guizhou

    Yunhe Gong

    Yunhe Gong

    Recruiting

  • People's Hospital of Meitan

    Zunyi, Guizhou

    Bin Guo

    Recruiting

  • People's Hospital of Renhuai

    Zunyi, Guizhou

    Yongming Cai

    Yongming Cai

    Recruiting

  • People's Hospital of Suiyang

    Zunyi, Guizhou

    Anze Chen

    Anze Chen

    Recruiting

  • People's Hospital of Tongzi

    Zunyi, Guizhou

    Nian Wang

    Nian Wang

    Recruiting

  • People's Hospital of Wuchuan Klau and Hmong autonomous county

    Zunyi, Guizhou

    Shijiang Tian

    Shijiang Tian

    Recruiting

  • People's Hospital of Xishui

    Zunyi, Guizhou

    Qianshu Zhao

    Qianshu Zhao

    Recruiting

  • People's Hospital of Yuqing

    Zunyi, Guizhou

    Ya Zeng

    Ya Zeng

    Recruiting

  • People's Hospital of Zhengan

    Zunyi, Guizhou

    Yun Zhan

    Yun Zhan

    Recruiting

  • Zunyi Infectious Disease Hospital

    Zunyi, Guizhou

    Youqian Chen

    Youqian Chen

    Recruiting

  • Zunyi Infectious Disease Hospital

    Zunyi, Guizhou

    Youqian Chen, +86 15870102934

    Recruiting

Other trials in China

About this study

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.

Read the 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.

Being tested
isoniazid and rifapentine, Rifampin and Isoniazid
Keywords
latent tuberculosis, TPT, active screening
Medical subject headings
Tuberculosis, Latent Tuberculosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • isoniazid and rifapentineDrug

    Also called 1H3P3

    12-dose ultra-short TPT 1H3P3 regimen of isoniazid and rifapentine 3 times a week for 4 weeks

  • Rifampin and IsoniazidDrug

    Also called 3HR

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

Study groups in NCT06022146
Study groupRoleWhat they receive
1H3P3 regimen of isoniazid and rifapentine 3 times a week for one monthExperimental12-dose ultra-short TPT 1H3P3 regimen of isoniazid and rifapentine 3 times a week for one month
Receives: Drug: isoniazid and rifapentine
3HR regimen of isoniazid and rifampicin once daily for three monthsActive comparator3HR regimen of isoniazid and rifampicin once daily for three months
Receives: Drug: Rifampin and Isoniazid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cumulative incidence of active tuberculosis (TB) over 24 months

    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.

    Measured: up to 24 months after randomization

Secondary outcomes (6)

  1. Proportion of participants with adverse events (AEs) and serious adverse events (SAEs)

    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.

    Measured: from first dose to one month after treatment completion

  2. Incidence of treatment discontinuation attributable to AEs

    To compare the treatment discontinuation rates due to AEs between the 1H3P3 and 3HR regimens

    Measured: During the treatment course period (up to 1 month for 1H3P3 arm and up to 3 months for 3HR arm).

  3. Treatment completion rate.

    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)

    Measured: up to 16 weeks from randomization

  4. All-cause mortality.

    Death from any cause during the 24-month follow-up period.

    Measured: up to 24 months after randomization

  5. Acquired drug resistance

    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.

    Measured: At time of active TB diagnosis, up to 24 months post-randomization.

  6. 2-year cumulative incidence of active TB in the non-intervention cohort

    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)

    Measured: From enrollment up to 24 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2023
  2. Study start1 Sep 2023
  3. Primary completion1 Sep 2026 (estimated)
  4. Study completion1 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3,520 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06022146
Sponsor's protocol ID
TB-YOUTH
Acronym
TB-YOUTH
Status last verified
Jul 2026
First submitted
23 Mar 2023
Last updated
14 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: This research targets adolescent students in school. We decide not to share IPD from the ethical perspective.

Publications

  • Yang Y, Zhou F, Ren Y, Li F, Yang Q, He Y, Wei X, Wang X, Luo J, Sun F, Shao L, Li J, Ruan Q, Zhang W. A Novel Therapy With a One-Month Ultrashort Regimen to Halt Progression From Latent Infection to Active Tuberculosis Among Close Contacts (The TB-YOUTH Study): Protocol for a Cluster Randomized Controlled Trial. JMIR Res Protoc. 2026 Jun 5;15:e89584. doi: 10.2196/89584.

    PubMed 42247627

  • 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.

    PubMed 40326358

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing isoniazid and rifapentine and Rifampin and Isoniazid in people with Tuberculosis and Latent Tuberculosis, run by Huashan Hospital at 66 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ruan Qiaoling, PhD (13661856002, ruan_qiao_ling@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative incidence of active tuberculosis (TB) over 24 months (time frame: up to 24 months after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06022146, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.

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