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
Sites (64)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| People's Hospital of Guanling Coordinator of this site? Confirm its status | Anshun | China | Recruiting |
| People's Hospital of Zhenning Coordinator of this site? Confirm its status | Anshun | China | Recruiting |
| People's Hospital of Pingba District Coordinator of this site? Confirm its status | Anshun | China | Recruiting |
| People's Hospital of Xixiu District Coordinator of this site? Confirm its status | Anshun | China | Recruiting |
| People's Hospital of Ziyun Coordinator of this site? Confirm its status | Anshun | China | Recruiting |
| People's Hospital of Puding Coordinator of this site? Confirm its status | Anshun | China | Recruiting |
| People's Hospital of Hezhang Coordinator of this site? Confirm its status | Bijie | China | Recruiting |
| People's Hospital of Qianxi Coordinator of this site? Confirm its status | Bijie | China | Recruiting |
| People's Hospital of Dafang Town Coordinator of this site? Confirm its status | Bijie | China | Recruiting |
| People's Hospital of Nayong Coordinator of this site? Confirm its status | Bijie | China | Recruiting |
| People's Hospital of Weining Coordinator of this site? Confirm its status | Bijie | China | Recruiting |
| People's Hospital of Zhijin Coordinator of this site? Confirm its status | Bijie | China | Recruiting |
| 3rd People's Hospital of Bijie Coordinator of this site? Confirm its status | Bijie | China | Recruiting |
| Dalian Public Health Clinical Center Coordinator of this site? Confirm its status | Dalian | China | Recruiting |
| People's Hospital of Daozhen Klau and Hmong autonomous county Coordinator of this site? Confirm its status | Daozhen Klau and Hmong Autonomous County in Zun'yi | China | Recruiting |
| People's Hospital of Huaxi District Coordinator of this site? Confirm its status | Guiyang | China | Recruiting |
| People's Hospital of Baiyun District Coordinator of this site? Confirm its status | Guiyang | China | Recruiting |
| Chinese Medicine Hospital of Qingzhen Coordinator of this site? Confirm its status | Guiyang | China | Recruiting |
| People's Hospital of Wudang District Coordinator of this site? Confirm its status | Guiyang | China | Recruiting |
| People's Hospital of Xifeng Coordinator of this site? Confirm its status | Guiyang | China | Recruiting |
| People's Hospital of Kaiyang Coordinator of this site? Confirm its status | Guiyang | China | Recruiting |
| People's Hospital of Xiuwen Coordinator of this site? Confirm its status | Guiyang | China | Recruiting |
| Guiyang Public Health Treatment Center Coordinator of this site? Confirm its status | Guiyang | China | Recruiting |
| Liuzhi Special District Coordinator of this site? Confirm its status | Liupanshui | China | Recruiting |
| People's Hospital of Shuicheng District, Liupanshui City Coordinator of this site? Confirm its status | Liupanshui | China | Recruiting |
| People's Hospital of Panzhou Coordinator of this site? Confirm its status | Liupanshui | China | Recruiting |
| Third People's Hospital of Liupanshui Coordinator of this site? Confirm its status | Liupanshui | China | Recruiting |
| Second People's Hospital of Liupanshui City Coordinator of this site? Confirm its status | Liupanshui | China | Recruiting |
| People's Hospital of Cengong Coordinator of this site? Confirm its status | Qiandongnan Miao and Dong Autonomous Prefecture | China | Recruiting |
| People's Hospital of Congjiang Coordinator of this site? Confirm its status | Qiandongnan Miao and Dong Autonomous Prefecture | China | Recruiting |
| People's Hospital of Jianhe Coordinator of this site? Confirm its status | Qiandongnan Miao and Dong Autonomous Region | China | Recruiting |
| First People's Hospital of Kaili Coordinator of this site? Confirm its status | Qiandongnan Miao and Dong Autonomous Region | China | Recruiting |
| People's Hospital of Rongjiang Coordinator of this site? Confirm its status | Qiandongnan Miao and Dong Autonomous Region | China | Recruiting |
| People's Hospital of Jinping Coordinator of this site? Confirm its status | Qiandongnan Miao and Dong Autonomous Region | China | Recruiting |
| People's Hospital of Tianzhu Coordinator of this site? Confirm its status | Qiandongnan Miao and Dong Autonomous Region | China | Recruiting |
| People's Hospital of Liping Coordinator of this site? Confirm its status | Qiandongnan Miao and Dong Autonomous Region | China | Recruiting |
| People's Hospital of Danzhai Coordinator of this site? Confirm its status | Qiandongnan Miao and Dong Autonomous Region | China | Recruiting |
| People's Hospital of Zhenyuan Coordinator of this site? Confirm its status | Qiandongnan Miao and Dong Autonomous Region | China | Recruiting |
| People's Hospital of Sansui Coordinator of this site? Confirm its status | Qiandongnan Miao and Dong Autonomous Region | China | Recruiting |
| People's Hospital of Leishan Coordinator of this site? Confirm its status | Qiandongnan Miao and Dong Autonomous Region | China | Recruiting |
| People's Hospital of Majiang Coordinator of this site? Confirm its status | Qiandongnan Miao and Dong Autonomous Region | China | Recruiting |
| People's Hospital of Taijiang Coordinator of this site? Confirm its status | Qiandongnan Miao and Dong Autonomous Region | China | Recruiting |
| People's Hospital of Huangping Coordinator of this site? Confirm its status | Qiandongnan Miao and Dong Autonomous Region | China | Recruiting |
| People's Hospital of Shibing Coordinator of this site? Confirm its status | Qiandongnan Miao and Dong Autonomous Region | China | Recruiting |
| First People's Hospital of Fuquan Coordinator of this site? Confirm its status | Qiannan | China | Recruiting |
| People's Hospital of Libo Coordinator of this site? Confirm its status | Qiannan | China | Recruiting |
| People's Hospital of Luodian Coordinator of this site? Confirm its status | Qiannan | China | Recruiting |
| People's Hospital of Changshun Coordinator of this site? Confirm its status | Qiannan | China | Recruiting |
| Huashan Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| People's Hospital of Wanshan District Coordinator of this site? Confirm its status | Tongren | China | Recruiting |
| People's Hospital of Renhuai Coordinator of this site? Confirm its status | Zunyi | China | Recruiting |
| Zunyi Infectious Disease Hospital Coordinator of this site? Confirm its status | Zunyi | China | Recruiting |
| People's Hospital of Suiyang Coordinator of this site? Confirm its status | Zunyi | China | Recruiting |
| Guizhou Aerospace Hospital Coordinator of this site? Confirm its status | Zunyi | China | Recruiting |
| People's Hospital of Xishui Coordinator of this site? Confirm its status | Zunyi | China | Recruiting |
| People's Hospital of Wuchuan Klau and Hmong autonomous county Coordinator of this site? Confirm its status | Zunyi | China | Recruiting |
| People's Hospital of Bozhou District Coordinator of this site? Confirm its status | Zunyi | China | Recruiting |
| People's Hospital of Tongzi Coordinator of this site? Confirm its status | Zunyi | China | Recruiting |
| People's Hospital of Chishui Coordinator of this site? Confirm its status | Zunyi | China | Recruiting |
| People's Hospital of Zhengan Coordinator of this site? Confirm its status | Zunyi | China | Recruiting |
| People's Hospital of Honghuagang District Coordinator of this site? Confirm its status | Zunyi | China | Recruiting |
| People's Hospital of Meitan Coordinator of this site? Confirm its status | Zunyi | China | Recruiting |
| People's Hospital of Yuqing Coordinator of this site? Confirm its status | Zunyi | China | Recruiting |
| People's Hospital of Fenggang Coordinator of this site? Confirm its status | Zunyi | China | Recruiting |
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This page is information, not medical advice. Discuss any trial with your doctor.