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

Launched by HUASHAN HOSPITAL · Aug 28, 2023

Keywords

ClinConnect Summary

The TB YOUTH trial is a study looking at a new way to treat latent tuberculosis (LTBI) in students who may have been exposed to someone with active tuberculosis (TB) in their school. The researchers want to see if a shorter treatment course of one month is just as effective as the standard three-month treatment. This study is important because it aims to find a quicker and possibly easier way for students to manage LTBI, which is a condition where the bacteria that cause TB are present in the body but do not cause any symptoms.

To be part of this trial, students aged 13 and older who have been in close contact with someone with active TB, and who test positive for LTBI, may be eligible. Participants will need to agree to join the study with the help of their guardians if they're under 18. They will receive treatment and regular check-ups during the study to monitor their health. It’s important to note that individuals with active TB, certain health conditions, or those who have had specific treatments in the past may not qualify. This trial is currently recruiting participants, and those interested should discuss it with their healthcare provider.

Gender

ALL

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.