RecruitingPhase 3NCT06022146
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)
Sponsor
Huashan Hospital
Enrollment
3,520 participants
Start Date
Sep 1, 2023
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 13 Years
Inclusion Criteria10
- 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 Criteria11
- 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.
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Interventions
DRUGisoniazid and rifapentine
12-dose ultra-short TPT 1H3P3 regimen of isoniazid and rifapentine 3 times a week for 4 weeks
DRUGRifampin and Isoniazid
3HR regimen of isoniazid and rifampicin once daily for three months
Locations(66)
View Full Details on ClinicalTrials.gov
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NCT06022146
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