1-Month Therapy for Latent Tuberculosis

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 3 Interventional Study
Tuberculosis Latent 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.

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About This Trial

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…
Contacts

Ruan Qiaoling, PhD

13661856002

ruan_qiao_ling@fudan.edu.cn

CONTACT

Zhang Wenhong, PhD

52888123

zhangwenhong@fudan.edu.cn

CONTACT