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NCT06022146RecruitingPhase 3

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)

Source: ClinicalTrials.gov · Last updated 14 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
3520 (estimated)
First submitted
23 Mar 2023
Start date
1 Sept 2023
Primary completion date
1 Sept 2026
Lead sponsor
Huashan Hospital
Diseases
Tuberculosis
NCT number
NCT06022146

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 3520
  • From 1 Sept 2023 to the primary completion date, 1 Sept 2026
  • 64 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior completion of full-course of treatment for ATB or LTBI;
  • Current receiving immunosuppressive therapy or biological agents.

Other illness

  • Current active TB disease (clinically or bacteriologically confirmed);
  • Documented isoniazid/rifampicin resistance in the corresponding M. tuberculosis strain from the index case;
  • Hypersensitivity or intolerance to rifamycins (rifapentine / rifampicin) or isoniazid;
  • HIV positive serostatus or AIDS patients;
  • History of viral hepatitis (e.g., chronic hepatitis B, chronic hepatitis C) or liver cirrhosis;
  • Other conditions deemed unsuitable for TPT by investigators.

Lab values

  • Liver dysfunction (TBil\>2.5mg/dL \[43umol/L\] or ALT / AST\>2ULN) or renal dysfunction.
  • Hematologic disorders with either PLT\<50×109/L or WBC\<3.0×109/L.

Other

  • Self-reported use of rifamycins (e.g., rifampicin, rifapentine) or isoniazid for \>14 consecutive days within the past 2 years;

Who the study is looking for

  • 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;
    • 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).

Age in the registry: 13 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (64)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
People's Hospital of Guanling
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AnshunChinaRecruiting
People's Hospital of Zhenning
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AnshunChinaRecruiting
People's Hospital of Pingba District
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AnshunChinaRecruiting
People's Hospital of Xixiu District
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AnshunChinaRecruiting
People's Hospital of Ziyun
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AnshunChinaRecruiting
People's Hospital of Puding
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AnshunChinaRecruiting
People's Hospital of Hezhang
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BijieChinaRecruiting
People's Hospital of Qianxi
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BijieChinaRecruiting
People's Hospital of Dafang Town
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BijieChinaRecruiting
People's Hospital of Nayong
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BijieChinaRecruiting
People's Hospital of Weining
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BijieChinaRecruiting
People's Hospital of Zhijin
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BijieChinaRecruiting
3rd People's Hospital of Bijie
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BijieChinaRecruiting
Dalian Public Health Clinical Center
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DalianChinaRecruiting
People's Hospital of Daozhen Klau and Hmong autonomous county
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Daozhen Klau and Hmong Autonomous County in Zun'yiChinaRecruiting
People's Hospital of Huaxi District
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GuiyangChinaRecruiting
People's Hospital of Baiyun District
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GuiyangChinaRecruiting
Chinese Medicine Hospital of Qingzhen
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GuiyangChinaRecruiting
People's Hospital of Wudang District
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GuiyangChinaRecruiting
People's Hospital of Xifeng
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GuiyangChinaRecruiting
People's Hospital of Kaiyang
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GuiyangChinaRecruiting
People's Hospital of Xiuwen
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GuiyangChinaRecruiting
Guiyang Public Health Treatment Center
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GuiyangChinaRecruiting
Liuzhi Special District
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LiupanshuiChinaRecruiting
People's Hospital of Shuicheng District, Liupanshui City
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LiupanshuiChinaRecruiting
People's Hospital of Panzhou
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LiupanshuiChinaRecruiting
Third People's Hospital of Liupanshui
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LiupanshuiChinaRecruiting
Second People's Hospital of Liupanshui City
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LiupanshuiChinaRecruiting
People's Hospital of Cengong
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Qiandongnan Miao and Dong Autonomous PrefectureChinaRecruiting
People's Hospital of Congjiang
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Qiandongnan Miao and Dong Autonomous PrefectureChinaRecruiting
People's Hospital of Jianhe
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Qiandongnan Miao and Dong Autonomous RegionChinaRecruiting
First People's Hospital of Kaili
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Qiandongnan Miao and Dong Autonomous RegionChinaRecruiting
People's Hospital of Rongjiang
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Qiandongnan Miao and Dong Autonomous RegionChinaRecruiting
People's Hospital of Jinping
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Qiandongnan Miao and Dong Autonomous RegionChinaRecruiting
People's Hospital of Tianzhu
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Qiandongnan Miao and Dong Autonomous RegionChinaRecruiting
People's Hospital of Liping
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Qiandongnan Miao and Dong Autonomous RegionChinaRecruiting
People's Hospital of Danzhai
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Qiandongnan Miao and Dong Autonomous RegionChinaRecruiting
People's Hospital of Zhenyuan
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Qiandongnan Miao and Dong Autonomous RegionChinaRecruiting
People's Hospital of Sansui
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Qiandongnan Miao and Dong Autonomous RegionChinaRecruiting
People's Hospital of Leishan
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Qiandongnan Miao and Dong Autonomous RegionChinaRecruiting
People's Hospital of Majiang
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Qiandongnan Miao and Dong Autonomous RegionChinaRecruiting
People's Hospital of Taijiang
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Qiandongnan Miao and Dong Autonomous RegionChinaRecruiting
People's Hospital of Huangping
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Qiandongnan Miao and Dong Autonomous RegionChinaRecruiting
People's Hospital of Shibing
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Qiandongnan Miao and Dong Autonomous RegionChinaRecruiting
First People's Hospital of Fuquan
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QiannanChinaRecruiting
People's Hospital of Libo
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QiannanChinaRecruiting
People's Hospital of Luodian
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QiannanChinaRecruiting
People's Hospital of Changshun
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QiannanChinaRecruiting
Huashan Hospital
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ShanghaiChinaRecruiting
People's Hospital of Wanshan District
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TongrenChinaRecruiting
People's Hospital of Renhuai
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ZunyiChinaRecruiting
Zunyi Infectious Disease Hospital
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ZunyiChinaRecruiting
People's Hospital of Suiyang
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ZunyiChinaRecruiting
Guizhou Aerospace Hospital
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ZunyiChinaRecruiting
People's Hospital of Xishui
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ZunyiChinaRecruiting
People's Hospital of Wuchuan Klau and Hmong autonomous county
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ZunyiChinaRecruiting
People's Hospital of Bozhou District
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ZunyiChinaRecruiting
People's Hospital of Tongzi
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ZunyiChinaRecruiting
People's Hospital of Chishui
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ZunyiChinaRecruiting
People's Hospital of Zhengan
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ZunyiChinaRecruiting
People's Hospital of Honghuagang District
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ZunyiChinaRecruiting
People's Hospital of Meitan
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ZunyiChinaRecruiting
People's Hospital of Yuqing
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ZunyiChinaRecruiting
People's Hospital of Fenggang
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ZunyiChinaRecruiting

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This page is information, not medical advice. Discuss any trial with your doctor.