Tuberculosis Clinical Trial
— TB-YOUTHOfficial title:
TB YOUTH - TB sYstemic Management Using One-month, Ultra-short TPT Regimen for scHool Contacts
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 | Recruiting |
Enrollment | 3520 |
Est. completion date | September 1, 2026 |
Est. primary completion date | September 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 13 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | People's Hospital of Liping Town | Autonomous Region | Guizhou |
China | 3rd People's Hospital of Bijie | Bijie | |
China | People's Hospital of Dafang Town | Bijie | |
China | People's Hospital of Nayong | Bijie | |
China | Chinese Medicine Hospital of Qingzhen | Guiyang | |
China | Central Hospital of Jingan District | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Huashan Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with culture or GeneXpert MTB/RIF confirmed TB or clinically highly suggested TB | The primary aim is to estimate the effectiveness non-inferiority of 1H3P3 to 3HR. | up to 24 months after treatment | |
Secondary | Number of participants permanently withdrawal from medication for any reason. | subjects may withdrawal from medication after serious adverse effect | up to 24 months after treatment | |
Secondary | N Number of participants complete the treatment. | to compare the completion rates of the two regimens | up to 24 months after treatment | |
Secondary | All-cause mortality. | subjects may withdrawal from this study because of death | up to 24 months after treatment | |
Secondary | Number of participants with drug resistance result. | to study drug resistance condition of school TB endemic | up to 24 months after treatment |
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