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)
Recruiting now · Phase 3
Conditions studied: Tuberculosis, Latent Tuberculosis
In brief
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.
Key facts
- Study ID
- NCT06022146
- Run by
- Huashan Hospital
- People needed
- 3520
- Starts
- 2023-09-01
- Expected to finish
- 2026-09-01
- Last updated by the study team
- 2026-07-14
Who can join
Age: 13 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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;
- 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.
Where it is running
- People's Hospital of Guanling — Anshun, Guizhou, China (enrolling)
- People's Hospital of Pingba District — Anshun, Guizhou, China (enrolling)
- People's Hospital of Puding — Anshun, Guizhou, China (enrolling)
- People's Hospital of Xixiu District — Anshun, Guizhou, China (enrolling)
- People's Hospital of Zhenning — Anshun, Guizhou, China (enrolling)
- People's Hospital of Hezhang — Bijie, Guizhou, China (enrolling)
- People's Hospital of Qianxi — Bijie, Guizhou, China (enrolling)
- People's Hospital of Qianxi — Bijie, Guizhou, China (enrolling)
- People's Hospital of Weining — Bijie, Guizhou, China (enrolling)
- People's Hospital of Zhijin — Bijie, Guizhou, China (enrolling)
- People's Hospital of Daozhen Klau and Hmong autonomous county — Daozhen Klau and Hmong Autonomous County in Zun'yi, Guizhou, China (enrolling)
- Guiyang Public Health Treatment Center — Guiyang, Guizhou, China (enrolling)
- People's Hospital of Baiyun District — Guiyang, Guizhou, China (enrolling)
- People's Hospital of Huaxi District — Guiyang, Guizhou, China (enrolling)
- People's Hospital of Kaiyang — Guiyang, Guizhou, China (enrolling)
- People's Hospital of Wudang District — Guiyang, Guizhou, China (enrolling)
- People's Hospital of Xifeng — Guiyang, Guizhou, China (enrolling)
- People's Hospital of Xiuwen — Guiyang, Guizhou, China (enrolling)
- Liuzhi Special District — Liupanshui, Guizhou, China (enrolling)
- People's Hospital of Panzhou — Liupanshui, Guizhou, China (enrolling)
- People's Hospital of Shuicheng District, Liupanshui City — Liupanshui, Guizhou, China (enrolling)
- Second People's Hospital of Liupanshui City — Liupanshui, Guizhou, China (enrolling)
- Third People's Hospital of Liupanshui — Liupanshui, Guizhou, China (enrolling)
- People's Hospital of Cengong — Qiandongnan Miao and Dong Autonomous Prefecture, Guizhou, China (enrolling)
- People's Hospital of Ziyun — Anshun, Guiyang, China (enrolling)
Full record on ClinicalTrials.gov
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