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Clinical Trials in China / NCT06022146
Recruiting Phase 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)

NCT06022146 · tracked via the Priya Life Science China tracker
Sponsor
Huashan Hospital
Phase
Phase 3
Started
2023-09-01
Last updated
2026-07-14

Condition(s) studied

TuberculosisLatent Tuberculosis

Investigational drug(s) / intervention(s)

isoniazid and rifapentineRifampin and Isoniazid

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

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

Study 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.

Eligibility

Sex
ALL
Min age
13 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (66)

FacilityCityRegionStatus
People's Hospital of Ziyun Anshun Guiyang Recruiting
People's Hospital of Guanling Anshun Guizhou Recruiting
People's Hospital of Pingba District Anshun Guizhou Recruiting
People's Hospital of Puding Anshun Guizhou Recruiting
People's Hospital of Xixiu District Anshun Guizhou Recruiting
People's Hospital of Zhenning Anshun Guizhou Recruiting
People's Hospital of Hezhang Bijie Guizhou Recruiting
People's Hospital of Qianxi Bijie Guizhou Recruiting
People's Hospital of Qianxi Bijie Guizhou Recruiting
People's Hospital of Weining Bijie Guizhou Recruiting
People's Hospital of Zhijin Bijie Guizhou Recruiting
People's Hospital of Daozhen Klau and Hmong autonomous county Daozhen Klau and Hmong Autonomous County in Zun'yi Guizhou Recruiting
Guiyang Public Health Treatment Center Guiyang Guizhou Recruiting
People's Hospital of Baiyun District Guiyang Guizhou Recruiting
People's Hospital of Huaxi District Guiyang Guizhou Recruiting
People's Hospital of Kaiyang Guiyang Guizhou Recruiting
People's Hospital of Wudang District Guiyang Guizhou Recruiting
People's Hospital of Xifeng Guiyang Guizhou Recruiting
People's Hospital of Xiuwen Guiyang Guizhou Recruiting
Liuzhi Special District Liupanshui Guizhou Recruiting
People's Hospital of Panzhou Liupanshui Guizhou Recruiting
People's Hospital of Shuicheng District, Liupanshui City Liupanshui Guizhou Recruiting
Second People's Hospital of Liupanshui City Liupanshui Guizhou Recruiting
Third People's Hospital of Liupanshui Liupanshui Guizhou Recruiting
People's Hospital of Cengong Qiandongnan Miao and Dong Autonomous Prefecture Guizhou Recruiting
People's Hospital of Congjiang Qiandongnan Miao and Dong Autonomous Prefecture Guizhou Recruiting
First People's Hospital of Kaili Qiandongnan Miao and Dong Autonomous Region Guizhou Recruiting
People's Hospital of Danzhai Qiandongnan Miao and Dong Autonomous Region Guizhou Recruiting
People's Hospital of Huangping Qiandongnan Miao and Dong Autonomous Region Guizhou Recruiting
People's Hospital of Jianhe Qiandongnan Miao and Dong Autonomous Region Guizhou Recruiting
People's Hospital of Jinping Qiandongnan Miao and Dong Autonomous Region Guizhou Recruiting
People's Hospital of Leishan Qiandongnan Miao and Dong Autonomous Region Guizhou Recruiting
People's Hospital of Liping Qiandongnan Miao and Dong Autonomous Region Guizhou Recruiting
People's Hospital of Rongjiang Qiandongnan Miao and Dong Autonomous Region Guizhou Recruiting
People's Hospital of Sansui Qiandongnan Miao and Dong Autonomous Region Guizhou Recruiting
People's Hospital of Shibing Qiandongnan Miao and Dong Autonomous Region Guizhou Recruiting
People's Hospital of Tianzhu Qiandongnan Miao and Dong Autonomous Region Guizhou Recruiting
People's Hospital of Zhenyuan Qiandongnan Miao and Dong Autonomous Region Guizhou Recruiting
First People's Hospital of Fuquan Qiannan Guizhou Recruiting
People's Hospital of Libo Qiannan Guizhou Recruiting

+ 26 more sites — see the full list on the official registry below.

More Huashan Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06022146 on ClinicalTrials.gov ↗ ← All trials in China