TB YOUTH - TB sYstemic Management Using One-month, Ultra-short TPT Regimen for scHool Contacts

KY-2023-020

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.

2023-09-01

2026-09-01

2026-09-01

Recruiting

Early phase I

3520

Inclusion Criteria: 1. Students of junior middle school, high school and university, age13 years old 2. Close contact of school active tuberculosis case (e.g. in the same classroom, in the same dormitory, in the same floor) 3. IGRA (Interferon-Gamma Release Assay) is positive and diagnosed as LTBI 4. Himself/herself (together with his/her guardian for age under 18 years old) willing to participate in trial and sign informed consent. Exclusion Criteria: 1. Current clinical or sputum culture confirmed active tuberculosis 2. Had continuously taken rifamycin (rifampicin, rifapentine etc.) or isoniazid for more than 14 days in the past 2 years 3. Have completed a full course of treatment for ATB or LTBI 4. Allergic or intolerant to rifamycin (rifapentine or rifampicin) or isoniazid 5. HIV (human immunodeficiency virus) antibody positive or AIDS (Acquired immunodeficiency syndrome) patients 6. History of viral hepatitis (e.g. chronic hepatitis B, chronic hepatitis C) or liver cirrhosis 7. Liver dysfunction (Total bilirubin \> 5mg/dL (43 umol/L) or Alanine aminotransferase \> 2ULN or Aspartate aminotransferase \> 2ULN) or renal dysfunction 8. Current receiving immunosuppressive therapy or biological agents 9. Blood system diseases or Platelet count\<50×10\^9/L or White Blood Cell count\<3.0×10\^9/L 10. Other conditions deemed unsuitable for TPT by physician.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 3520, 'type': 'ESTIMATED'}}

2023-11-13