NCT06022146 TB YOUTH - TB sYstemic Management Using One-month, Ultra-short TPT Regimen for scHool Contacts
| NCT ID | NCT06022146 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Huashan Hospital |
| Condition | Tuberculosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 3,520 participants |
| Start Date | 2023-09-01 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 3,520 participants in total. It began in 2023-09-01 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06022146 clinical trial?
This trial is open to participants of all sexes, aged 13 Years or older, studying Tuberculosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06022146 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 3,520 participants.
Is NCT06022146 currently recruiting?
Yes, NCT06022146 is actively recruiting participants. Contact the research team at ruan_qiao_ling@fudan.edu.cn for enrollment information.
Where is the NCT06022146 trial being conducted?
This trial is being conducted at Bijie, China, Bijie, China, Bijie, China, Bijie, China and 11 additional locations.
Who is sponsoring the NCT06022146 clinical trial?
NCT06022146 is sponsored by Huashan Hospital. The trial plans to enroll 3,520 participants.