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

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ClinicalTrials.gov Identifier: NCT06022146
Recruitment Status : Recruiting
First Posted : September 1, 2023
Last Update Posted : November 13, 2023
Sponsor:
Information provided by (Responsible Party):
Wen-hong Zhang, Huashan Hospital

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Tuberculosis Latent Tuberculosis Drug: Rifampin and Isoniazid Drug: isoniazid and rifapentine Phase 3

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3520 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: TB YOUTH - TB sYstemic Management Using One-month, Ultra-short TPT Regimen for scHool Contacts
Actual Study Start Date : September 1, 2023
Estimated Primary Completion Date : September 1, 2026
Estimated Study Completion Date : September 1, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1H3P3 regimen of isoniazid and rifapentine 3 times a week for one month
12-dose ultra-short TPT 1H3P3 regimen of isoniazid and rifapentine 3 times a week for one month
 Drug: Rifampin and Isoniazid
3HR regimen of isoniazid and rifampicin once daily for three months
Active Comparator: 3HR regimen of isoniazid and rifampicin once daily for three months
3HR regimen of isoniazid and rifampicin once daily for three months
 Drug: isoniazid and rifapentine
12-dose ultra-short TPT 1H3P3 regimen of isoniazid and rifapentine 3 times a week for one month


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with culture or GeneXpert MTB/RIF confirmed TB or clinically highly suggested TB [ Time Frame: up to 24 months after treatment ]
    The primary aim is to estimate the effectiveness non-inferiority of 1H3P3 to 3HR.


Secondary Outcome Measures :
  1. Number of participants permanently withdrawal from medication for any reason. [ Time Frame: up to 24 months after treatment ]
    subjects may withdrawal from medication after serious adverse effect

  2. N Number of participants complete the treatment. [ Time Frame: up to 24 months after treatment ]
    to compare the completion rates of the two regimens

  3. All-cause mortality. [ Time Frame: up to 24 months after treatment ]
    subjects may withdrawal from this study because of death

  4. Number of participants with drug resistance result. [ Time Frame: up to 24 months after treatment ]
    to study drug resistance condition of school TB endemic


Eligibility Criteria
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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06022146


Contacts
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Contact: Ruan Qiaoling, PhD 13661856002 ruan_qiao_ling@fudan.edu.cn
Contact: Zhang Wenhong, PhD 52888123 zhangwenhong@fudan.edu.cn

Locations
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China, Guizhou
People's Hospital of Liping Town Recruiting
Autonomous Region, Guizhou, China
China, Shanghai
Central Hospital of Jingan District Recruiting
Shanghai, Shanghai, China, 200040
Contact: Wenhong Zhang, Prof    021-61578000      
China
3rd People's Hospital of Bijie Recruiting
Bijie, China
Contact: Lijuan Lin         
People's Hospital of Dafang Town Recruiting
Bijie, China
Contact: Zhengjie Jiang         
People's Hospital of Nayong Recruiting
Bijie, China
Contact: Qili Liu         
Chinese Medicine Hospital of Qingzhen Recruiting
Guiyang, China
Contact: Jie Yang         
Sponsors and Collaborators
Huashan Hospital
More Information
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Responsible Party: Wen-hong Zhang, Professor, Huashan Hospital
ClinicalTrials.gov Identifier: NCT06022146    
Other Study ID Numbers: KY-2023-020
First Posted: September 1, 2023    Key Record Dates
Last Update Posted: November 13, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This research targets adolescent students in school. We decide not to share IPD from the ethical perspective.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wen-hong Zhang, Huashan Hospital:
latent tuberculosis
TPT
active screening
Additional relevant MeSH terms:
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Tuberculosis
Latent Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Latent Infection
Rifampin
Rifapentine
Isoniazid
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
 Anti-Infective Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents