One-month treatment for latent tuberculosis in school contacts

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• People's Hospital of Ziyun
  Anshun, Guiyang, China Recruiting
• People's Hospital of Guanling
  Anshun, Guizhou, China Recruiting
• People's Hospital of Pingba District
  Anshun, Guizhou, China Recruiting
• People's Hospital of Puding
  Anshun, Guizhou, China Recruiting
• People's Hospital of Xixiu District
  Anshun, Guizhou, China Recruiting
• People's Hospital of Zhenning
  Anshun, Guizhou, China Recruiting

+16 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Ruan Qiaoling, PhD
• Email: ruan_qiao_ling@fudan.edu.cn
• Phone: 13661856002

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.