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One-month treatment for latent tuberculosis in school contacts

TB YOUTH - TB sYstemic Management Using One-month, Ultra-short TPT Regimen for scHool Contacts

Phase 3 Interventional Huashan Hospital · NCT06022146

This study is testing if a one-month treatment for latent tuberculosis can help protect school-aged kids who have been in close contact with someone who has TB.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment3520 (estimated)
Ages13 Years and up
SexAll
SponsorHuashan Hospital Academic / other
Locations47 sites (Bijie, Guizhou and 46 other locations)
Trial IDNCT06022146 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of a one-month treatment regimen for latent tuberculosis (LTBI) in adolescents who are close contacts of tuberculosis cases in schools. It is a multicenter, open-label, cluster randomized controlled trial conducted in GuiZhou, China, where students will be screened for LTBI using various diagnostic tests. Eligible participants will receive either a three-month regimen or a one-month regimen of preventive treatment and will be followed for two years to assess the incidence of active tuberculosis. The study seeks to address the gap in targeted interventions for TB prevention among adolescents in school settings.

Who should consider this trial

Good fit: Ideal candidates for this study are adolescents aged 13 years and older who are students or school staff and have been diagnosed with latent tuberculosis infection.

Not a fit: Patients currently suffering from active tuberculosis or those with a history of severe liver dysfunction or HIV/AIDS may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly reduce the incidence of active tuberculosis among adolescents by providing an effective and shorter treatment option for latent tuberculosis.

How similar studies have performed: Other studies have shown promising results with shorter treatment regimens for latent tuberculosis, indicating that this approach may be effective.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Bijie, Guizhou and 46 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions TuberculosisLatent Tuberculosislatent tuberculosisTPTactive screening
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.