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

Tuberculosis Clinical Trial

— TB-YOUTH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06022146
• Other study ID #: KY-2023-020
• Status: Recruiting
• Phase: Phase 3
• Start date: September 1, 2023
• Est. completion date: September 1, 2026

Study information

• Verified date: November 2023
• Source: Huashan Hospital
• Contact: Ruan Qiaoling, PhD
• Phone: 13661856002
• Email: ruan_qiao_ling[@]fudan.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Background： Adolescents are susceptible to tuberculosis. Almost 1.1 million children (aged below 15 years) and another half a million older adolescents (15-19 years) become ill with TB every year. Approximately 5%-10% people infected with TB develop to active disease, which suggest that a great proportion of adolescents remain undiagnosed and unprotected. Undiagnosed cases and school-based transmission contribute to the burden of TB among adolescents. Closing the gap in targeted interventions for TB prevention in schools is essential to break the cycle of transmission and ensure the well-being of school-aged adolescents. However, TB preventive treatment targeted on adolescents are still lacking.

Method： This is a prospective, multicenter, open-label, non-inferiority, cluster randomized controlled clinical trial within the national tuberculosis control program of GuiZhou,China. Close contacts of school tuberculosis index cases are actively screened with QFT(QuantiFERON-TB Gold Plus), chest X-ray, pooled GeneXpert MTB/RIF test of sputum and symptoms. After ruling out active tuberculosis, LTBI students are enrolled to attend a non-inferiority, cluster randomized controlled clinical trial. The students will be given either 3HR or 1H3P3 regimen and followed for two years. Our primary endpoint is culture or GeneXpert MTB/RIF confirmed TB or clinically highly suggested TB. Assume ICC (interclass correlation coefficient) to be 0.05, the study will need 1658 subjects per arm to provide 80% power to detect a 20% non-inferiority margin of primary endpoint between the two arms.

Discussion:

The effectiveness of contact investigation among adolescent students as a tool for improved tuberculosis control has not been established. The integration of ultra-short treatment regimens with active screening holds the potential to provide a comprehensive and effective strategy for tuberculosis prevention and control in school environments, which may help reform the national tuberculosis policy regarding adolescent TB.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3520
• Est. completion date: September 1, 2026
• Est. primary completion date: September 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

Inclusion Criteria:

1. Students of junior middle school, high school and university, age13 years old

2. Close contact of school active tuberculosis case (e.g. in the same classroom, in the same dormitory, in the same floor)

3. IGRA (Interferon-Gamma Release Assay) is positive and diagnosed as LTBI

4. Himself/herself (together with his/her guardian for age under 18 years old) willing to participate in trial and sign 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.

Related Conditions & MeSH terms

• Latent Tuberculosis
• Tuberculosis

Intervention

Drug:
• Rifampin and Isoniazid
3HR regimen of isoniazid and rifampicin once daily for three months
• isoniazid and rifapentine
12-dose ultra-short TPT 1H3P3 regimen of isoniazid and rifapentine 3 times a week for one month

Locations

Country	Name	City	State
China	People's Hospital of Liping Town	Autonomous Region	Guizhou
China	3rd People's Hospital of Bijie	Bijie
China	People's Hospital of Dafang Town	Bijie
China	People's Hospital of Nayong	Bijie
China	Chinese Medicine Hospital of Qingzhen	Guiyang
China	Central Hospital of Jingan District	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with culture or GeneXpert MTB/RIF confirmed TB or clinically highly suggested TB	The primary aim is to estimate the effectiveness non-inferiority of 1H3P3 to 3HR.	up to 24 months after treatment
Secondary	Number of participants permanently withdrawal from medication for any reason.	subjects may withdrawal from medication after serious adverse effect	up to 24 months after treatment
Secondary	N Number of participants complete the treatment.	to compare the completion rates of the two regimens	up to 24 months after treatment
Secondary	All-cause mortality.	subjects may withdrawal from this study because of death	up to 24 months after treatment
Secondary	Number of participants with drug resistance result.	to study drug resistance condition of school TB endemic	up to 24 months after treatment