Status:
RECRUITING
TB YOUTH - TB sYstemic Management Using One-month, Ultra-short TPT Regimen for scHool Contacts
Lead Sponsor:
Huashan Hospital
Conditions:
Tuberculosis
Latent Tuberculosis
Eligibility:
All Genders
13+ years
Phase:
PHASE3
Brief 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.
Detailed Description
Background： Adolescents are susceptible to tuberculosis. Almost 1.1 million children (aged below 15 years) and another half a million older adolescents (15-19 years) become ill with TB every year. App...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
3520 Patients enrolled
Trial Details
Trial ID
NCT06022146
Start Date
September 1 2023
End Date
September 1 2026
Last Update
December 22 2025
Active Locations (47)
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1
People's Hospital of Hezhang
Bijie, Guizhou, China
2
People's Hospital of Qianxi
Bijie, Guizhou, China
3
People's Hospital of Weining
Bijie, Guizhou, China
4
People's Hospital of Zhijin
Bijie, Guizhou, China