xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06022146</url>
    </required_header>
    <id_info>
      <org_study_id>KY-2023-020</org_study_id>
      <nct_id>NCT06022146</nct_id>
    </id_info>
    <brief_title>TB YOUTH - TB sYstemic Management Using One-month, Ultra-short TPT Regimen for scHool Contacts</brief_title>
    <acronym>TB-YOUTH</acronym>
    <official_title>TB YOUTH - TB sYstemic Management Using One-month, Ultra-short TPT Regimen for scHool Contacts</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Huashan Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Huashan Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a prospective, multi-center, open-label, cluster randomized controlled clinical trial&#xD;
        conducted in school settings to estimate the non-inferiority effect of 1H3P3 compared with&#xD;
        3HR.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Background： Adolescents are susceptible to tuberculosis. Almost 1.1 million children (aged&#xD;
        below 15 years) and another half a million older adolescents (15-19 years) become ill with TB&#xD;
        every year. Approximately 5%-10% people infected with TB develop to active disease, which&#xD;
        suggest that a great proportion of adolescents remain undiagnosed and unprotected.&#xD;
        Undiagnosed cases and school-based transmission contribute to the burden of TB among&#xD;
        adolescents. Closing the gap in targeted interventions for TB prevention in schools is&#xD;
        essential to break the cycle of transmission and ensure the well-being of school-aged&#xD;
        adolescents. However, TB preventive treatment targeted on adolescents are still lacking.&#xD;
  &#xD;
        Method： This is a prospective, multicenter, open-label, non-inferiority, cluster randomized&#xD;
        controlled clinical trial within the national tuberculosis control program of GuiZhou,China.&#xD;
        Close contacts of school tuberculosis index cases are actively screened with&#xD;
        QFT(QuantiFERON-TB Gold Plus), chest X-ray, pooled GeneXpert MTB/RIF test of sputum and&#xD;
        symptoms. After ruling out active tuberculosis, LTBI students are enrolled to attend a&#xD;
        non-inferiority, cluster randomized controlled clinical trial. The students will be given&#xD;
        either 3HR or 1H3P3 regimen and followed for two years. Our primary endpoint is culture or&#xD;
        GeneXpert MTB/RIF confirmed TB or clinically highly suggested TB. Assume ICC (interclass&#xD;
        correlation coefficient) to be 0.05, the study will need 1658 subjects per arm to provide 80%&#xD;
        power to detect a 20% non-inferiority margin of primary endpoint between the two arms.&#xD;
  &#xD;
        Discussion:&#xD;
  &#xD;
        The effectiveness of contact investigation among adolescent students as a tool for improved&#xD;
        tuberculosis control has not been established. The integration of ultra-short treatment&#xD;
        regimens with active screening holds the potential to provide a comprehensive and effective&#xD;
        strategy for tuberculosis prevention and control in school environments, which may help&#xD;
        reform the national tuberculosis policy regarding adolescent TB.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 13, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2026</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2026</primary_completion_date>
    <phase>Phase 3</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of participants with culture or GeneXpert MTB/RIF confirmed TB or clinically highly suggested TB</measure>
      <time_frame>up to 24 months after treatment</time_frame>
      <description>The primary aim is to estimate the effectiveness non-inferiority of 1H3P3 to 3HR.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of participants permanently withdrawal from medication for any reason.</measure>
      <time_frame>up to 24 months after treatment</time_frame>
      <description>subjects may withdrawal from medication after serious adverse effect</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>N Number of participants complete the treatment.</measure>
      <time_frame>up to 24 months after treatment</time_frame>
      <description>to compare the completion rates of the two regimens</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>All-cause mortality.</measure>
      <time_frame>up to 24 months after treatment</time_frame>
      <description>subjects may withdrawal from this study because of death</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with drug resistance result.</measure>
      <time_frame>up to 24 months after treatment</time_frame>
      <description>to study drug resistance condition of school TB endemic</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">3316</enrollment>
    <condition>Tuberculosis</condition>
    <condition>Latent Tuberculosis</condition>
    <arm_group>
      <arm_group_label>1H3P3 regimen of isoniazid and rifapentine 3 times a week for one month</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>12-dose ultra-short TPT 1H3P3 regimen of isoniazid and rifapentine 3 times a week for one month</description>
    </arm_group>
    <arm_group>
      <arm_group_label>3HR regimen of isoniazid and rifampicin once daily for three months</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>3HR regimen of isoniazid and rifampicin once daily for three months</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Rifampin and Isoniazid</intervention_name>
      <description>3HR regimen of isoniazid and rifampicin once daily for three months</description>
      <arm_group_label>1H3P3 regimen of isoniazid and rifapentine 3 times a week for one month</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>isoniazid and rifapentine</intervention_name>
      <description>12-dose ultra-short TPT 1H3P3 regimen of isoniazid and rifapentine 3 times a week for one month</description>
      <arm_group_label>3HR regimen of isoniazid and rifampicin once daily for three months</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Students of junior middle school, high school and university, age13 years old&#xD;
  &#xD;
            2. Close contact of school active tuberculosis case (e.g. in the same classroom, in the&#xD;
               same dormitory, in the same floor)&#xD;
  &#xD;
            3. IGRA (Interferon-Gamma Release Assay) is positive and diagnosed as LTBI&#xD;
  &#xD;
            4. Himself/herself (together with his/her guardian for age under 18 years old) willing to&#xD;
               participate in trial and sign informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Current clinical or sputum culture confirmed active tuberculosis&#xD;
  &#xD;
            2. Had continuously taken rifamycin (rifampicin, rifapentine etc.) or isoniazid for more&#xD;
               than 14 days in the past 2 years&#xD;
  &#xD;
            3. Have completed a full course of treatment for ATB or LTBI&#xD;
  &#xD;
            4. Allergic or intolerant to rifamycin (rifapentine or rifampicin) or isoniazid&#xD;
  &#xD;
            5. HIV (human immunodeficiency virus) antibody positive or AIDS (Acquired&#xD;
               immunodeficiency syndrome) patients&#xD;
  &#xD;
            6. History of viral hepatitis (e.g. chronic hepatitis B, chronic hepatitis C) or liver&#xD;
               cirrhosis&#xD;
  &#xD;
            7. Liver dysfunction (Total bilirubin &gt; 5mg/dL (43 umol/L) or Alanine aminotransferase &gt;&#xD;
               2ULN or Aspartate aminotransferase &gt; 2ULN) or renal dysfunction&#xD;
  &#xD;
            8. Current receiving immunosuppressive therapy or biological agents&#xD;
  &#xD;
            9. Blood system diseases or Platelet count&lt;50×10^9/L or White Blood Cell count&lt;3.0×10^9/L&#xD;
  &#xD;
           10. Other conditions deemed unsuitable for TPT by physician.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>13 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Ruan Qiaoling, PhD</last_name>
      <phone>13661856002</phone>
      <email>ruan_qiao_ling@fudan.edu.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Zhang Wenhong, PhD</last_name>
      <phone>52888123</phone>
      <email>zhangwenhong@fudan.edu.cn</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Central Hospital of Jingan District</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <zip>200040</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Wenhong Zhang, Prof</last_name>
        <phone>021-61578000</phone>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>March 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Huashan Hospital</investigator_affiliation>
      <investigator_full_name>Wen-hong Zhang</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>latent tuberculosis</keyword>
    <keyword>TPT</keyword>
    <keyword>active screening</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Tuberculosis</mesh_term>
      <mesh_term>Latent Tuberculosis</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Rifampin</mesh_term>
      <mesh_term>Rifapentine</mesh_term>
      <mesh_term>Isoniazid</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>This research targets adolescent students in school. We decide not to share IPD from the ethical perspective.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06022146
  org study id: KY-2023-020
  nct id: NCT06022146
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Number of participants with culture or GeneXpert MTB/RIF confirmed TB or clinically highly suggested TB
  time frame: up to 24 months after treatment
  description: The primary aim is to estimate the effectiveness non-inferiority of 1H3P3 to 3HR.
  measure: Number of participants permanently withdrawal from medication for any reason.
  time frame: up to 24 months after treatment
  description: subjects may withdrawal from medication after serious adverse effect
  measure: N Number of participants complete the treatment.
  time frame: up to 24 months after treatment
  description: to compare the completion rates of the two regimens
  measure: All-cause mortality.
  time frame: up to 24 months after treatment
  description: subjects may withdrawal from this study because of death
  measure: Number of participants with drug resistance result.
  time frame: up to 24 months after treatment
  description: to study drug resistance condition of school TB endemic
  arm group label: 1H3P3 regimen of isoniazid and rifapentine 3 times a week for one month
  arm group type: Experimental
  description: 12-dose ultra-short TPT 1H3P3 regimen of isoniazid and rifapentine 3 times a week for one month
  arm group label: 3HR regimen of isoniazid and rifampicin once daily for three months
  arm group type: Active Comparator
  description: 3HR regimen of isoniazid and rifampicin once daily for three months
  intervention type: Drug
  intervention name: Rifampin and Isoniazid
  description: 3HR regimen of isoniazid and rifampicin once daily for three months
  arm group label: 1H3P3 regimen of isoniazid and rifapentine 3 times a week for one month
  intervention type: Drug
  intervention name: isoniazid and rifapentine
  description: 12-dose ultra-short TPT 1H3P3 regimen of isoniazid and rifapentine 3 times a week for one month
  arm group label: 3HR regimen of isoniazid and rifampicin once daily for three months
  criteria: 
  gender: All
  minimum age: 13 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Ruan Qiaoling, PhD
  phone: 13661856002
  email: ruan_qiao_ling@fudan.edu.cn
  last name: Zhang Wenhong, PhD
  phone: 52888123
  email: zhangwenhong@fudan.edu.cn
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Huashan Hospital
  investigator full name: Wen-hong Zhang
  investigator title: Professor
  mesh term: Tuberculosis
  mesh term: Latent Tuberculosis
  mesh term: Rifampin
  mesh term: Rifapentine
  mesh term: Isoniazid
  sharing ipd: No
  ipd description: This research targets adolescent students in school. We decide not to share IPD from the ethical perspective.