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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

RecruitingPhase 3

Sponsor: Huashan Hospital

Conditions: Tuberculosis, Latent Tuberculosis

Interventions: isoniazid and rifapentine, Rifampin and Isoniazid

Countries: China

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 overview

Sex: ALL

Age: 13 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (66)

Anshun, Guiyang, China
Anshun, Guizhou, China
Anshun, Guizhou, China
Anshun, Guizhou, China
Anshun, Guizhou, China
Anshun, Guizhou, China
Bijie, Guizhou, China
Bijie, Guizhou, China
Bijie, Guizhou, China
Bijie, Guizhou, China
Bijie, Guizhou, China
Daozhen Klau and Hmong Autonomous County in Zun'yi, Guizhou, China
Guiyang, Guizhou, China
Guiyang, Guizhou, China
Guiyang, Guizhou, China
Guiyang, Guizhou, China
Guiyang, Guizhou, China
Guiyang, Guizhou, China
Guiyang, Guizhou, China
Liupanshui, Guizhou, China
Liupanshui, Guizhou, China
Liupanshui, Guizhou, China
Liupanshui, Guizhou, China
Liupanshui, Guizhou, China
Qiandongnan Miao and Dong Autonomous Prefecture, Guizhou, China
Qiandongnan Miao and Dong Autonomous Prefecture, Guizhou, China
Qiandongnan Miao and Dong Autonomous Region, Guizhou, China
Qiandongnan Miao and Dong Autonomous Region, Guizhou, China
Qiandongnan Miao and Dong Autonomous Region, Guizhou, China
Qiandongnan Miao and Dong Autonomous Region, Guizhou, China
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