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. Male or female, ≥13 years old, weighting ≥30kg;
• • 2. Students of junior middle school, high school or college, or school staff;
• • 3. In the scope of ATB case-driven screening delimited by local CDC;
• • 4. Positive in IGRA test and diagnosed as LTBI;
• • 5. Voluntary (together with his/her guardian for age under 18 years old) participant in trial and signed informed consent.
• Exclusion Criteria:
• • 1. Current clinical or sputum culture confirmed active tuberculosis
• • 2. Had continuously taken rifamycin (rifampicin, rifapentine etc.) or isoniazid for more than 14 days in the past 2 years
• • 3. Have completed a full course of treatment for ATB or LTBI
• • 4. Allergic or intolerant to rifamycin (rifapentine or rifampicin) or isoniazid
• • 5. HIV (human immunodeficiency virus) antibody positive or AIDS (Acquired immunodeficiency syndrome) patients
• • 6. History of viral hepatitis (e.g. chronic hepatitis B, chronic hepatitis C) or liver cirrhosis
• • 7. Liver dysfunction (Total bilirubin \> 5mg/dL (43 umol/L) or Alanine aminotransferase \> 2ULN or Aspartate aminotransferase \> 2ULN) or renal dysfunction
• • 8. Current receiving immunosuppressive therapy or biological agents
• • 9. Blood system diseases or Platelet count\<50×10\^9/L or White Blood Cell count\<3.0×10\^9/L
• • 10. Other conditions deemed unsuitable for TPT by physician.