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)
Recruiting
Phase 3Interventional Study
TuberculosisLatent Tuberculosis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
13 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Prevention
Participants needed
3,520 (estimated)
Sponsor
Huashan Hospital · Other
Who this trial is looking for
This trial is looking for school-aged individuals who are close contacts of someone with active tuberculosis. Participants will take a new treatment to see if it helps prevent them from developing active TB.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 13 years old
I weigh at least 30 kg
I am registered at a school
I have close contact with someone who has active tuberculosis
I have been diagnosed with latent tuberculosis
I agree to participate and have a signed consent form
You may not be able to join if
I currently have active tuberculosis
I have a history of resistance to certain TB medications
I took rifamycins or isoniazid for more than 14 days in the last 2 years
I have completed treatment for active TB or latent TB before
I am allergic to rifamycins or isoniazid
I am HIV positive or have AIDS
I have viral hepatitis or liver cirrhosis
I have liver or kidney dysfunction
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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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…
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.
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