<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/NCT03266991</url>
  </required_header>
  <id_info>
    <org_study_id>A101A</org_study_id>
    <nct_id>NCT03266991</nct_id>
  </id_info>
  <brief_title>Treatment of Latent Tuberculosis in Socially Marginalised Citizens</brief_title>
  <acronym>DOT-LTBI</acronym>
  <official_title>A Randomised Controlled Trial of a 12-dose Rifapentine and Isoniazid (RPT+INH) Regimen Using Direct Observed Therapy (DOT) Versus 6 Months of Daily Isoniazid for Latent Tuberculosis Infection (LTBI) in Socially Marginalised People</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aarhus University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aarhus University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      An open-label, randomised controlled trial comparing compliance to treatment for latent&#xD;
      tuberculosis infection in socially marginalised citizens. Participants will be randomized to&#xD;
      either daily isoniazid for 6 months or weekly rifapentine and isoniazid as directly observed&#xD;
      therapy for twelve weeks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Eligible participants will be randomised to receive either daily isoniazid for 6 months with&#xD;
      monthly visits for pill count, evaluation of adverse events and dispensing of isoniazid for&#xD;
      the next month, or weekly doses of rifapentine and isoniazid for twelve weeks as direct&#xD;
      observed therapy where the drugs are administered in the presence of a study nurse or doctor.&#xD;
&#xD;
      Control bloodsamples (ALAT, alkaline phosphatase, bilirubin, INR, haemoglobin, trombocytes&#xD;
      and leukocyte differential count) will be taken at baseline and at least once during&#xD;
      treatment in the rifapentine and isoniazid group and at least twice in the isoniazid-only&#xD;
      group.&#xD;
&#xD;
      One year after treatment completion participants will be called in for evaluation for active&#xD;
      tuberculosis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 27, 2017</start_date>
  <completion_date type="Anticipated">January 2026</completion_date>
  <primary_completion_date type="Anticipated">January 2022</primary_completion_date>
  <phase>Phase 4</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>adherence</measure>
    <time_frame>2 years</time_frame>
    <description>adherence to treatment in the two groups measured by counting number of pills taken in each group.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>active tuberculosis</measure>
    <time_frame>5 years</time_frame>
    <description>active tuberculosis within the study period. In case of suspected tuberculosis during the study the participant will be refered for examination by specialists. At 1 year follow-up participants will have a chest x-ray and physical examination by study doctor to screen for signs of active tuberculosis. If active tuberculosis is suspected further examinations will be performed by specialists.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adverse events</measure>
    <time_frame>2 years</time_frame>
    <description>for both groups all adverse events will be recorded</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Compliance, Patient</condition>
  <arm_group>
    <arm_group_label>RPT-INH</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants treated with weekly rifapentine and isoniazid for twelve weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants treated with daily isoniazid for six months</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rifapentine</intervention_name>
    <description>Treatment with weekly rifapentine and isoniazid as Directly Observed Therapy in 12 weeks</description>
    <arm_group_label>RPT-INH</arm_group_label>
    <other_name>isoniazid</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Isoniazid</intervention_name>
    <description>Treatment with daily isoniazid in 6 months</description>
    <arm_group_label>RPT-INH</arm_group_label>
    <arm_group_label>control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Reporting to be homeless (independent of whether the person has an official address)&#xD;
             or regularly seeking homeless shelters or public institutions to supply basic needs&#xD;
&#xD;
          -  LTBI defined by positive IGRA test&#xD;
&#xD;
          -  Found plausible by study doctor that the person has been exposed to tuberculosis&#xD;
             within 2 years&#xD;
&#xD;
          -  Aged 18 years or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previously treated for tuberculosis&#xD;
&#xD;
          -  Pregnant or breastfeeding&#xD;
&#xD;
          -  Active tuberculosis (evaluated by chest x-ray and examination by a trained doctor)&#xD;
&#xD;
          -  Unable to give informed consent&#xD;
&#xD;
          -  Tested positive for LTBI as part of contact investigation where the index case has or&#xD;
             is suspected to have INH of RIF resistant TB&#xD;
&#xD;
          -  Known HIV on antiretroviral treatment&#xD;
&#xD;
          -  Porphyria&#xD;
&#xD;
          -  Known allergy to rifamycins or isoniazid&#xD;
&#xD;
          -  Known epilepsy&#xD;
&#xD;
          -  Known liver disease causing affected liver parameters (ALAT, alkaline phosphatase,&#xD;
             bilirubin, INR)&#xD;
&#xD;
          -  Any lab abnormality, disease, concomitant medication or condition that, in the opinion&#xD;
             of the investigator, excludes a person from participating&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christian Wejse, MD PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aarhus University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nina B Staerke, MD</last_name>
    <phone>004523647984</phone>
    <email>ninase@rm.dk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Dept of Pulmonary Medicine</name>
      <address>
        <city>Aarhus</city>
        <zip>8000</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nina B Staerke, MD</last_name>
      <email>ninase@rm.dk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dept of Pulmonary Medicine</name>
      <address>
        <city>Esbjerg</city>
        <zip>6700</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Torben Jensen, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>August 11, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>July 26, 2021</last_update_submitted>
  <last_update_submitted_qc>July 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aarhus University Hospital</investigator_affiliation>
    <investigator_full_name>Nina Breinholt Stærke</investigator_full_name>
    <investigator_title>MD phd-student</investigator_title>
  </responsible_party>
  <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>Isoniazid</mesh_term>
    <mesh_term>Rifapentine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03266991
org study id: A101A
nct id: NCT03266991
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
An open-label, randomised controlled trial comparing compliance to treatment for latent
      tuberculosis infection in socially marginalised citizens. Participants will be randomized to
      either daily isoniazid for 6 months or weekly rifapentine and isoniazid as directly observed
      therapy for twelve weeks.
Eligible participants will be randomised to receive either daily isoniazid for 6 months with
      monthly visits for pill count, evaluation of adverse events and dispensing of isoniazid for
      the next month, or weekly doses of rifapentine and isoniazid for twelve weeks as direct
      observed therapy where the drugs are administered in the presence of a study nurse or doctor.

      Control bloodsamples (ALAT, alkaline phosphatase, bilirubin, INR, haemoglobin, trombocytes
      and leukocyte differential count) will be taken at baseline and at least once during
      treatment in the rifapentine and isoniazid group and at least twice in the isoniazid-only
      group.

      One year after treatment completion participants will be called in for evaluation for active
      tuberculosis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: adherence
time frame: 2 years
description: adherence to treatment in the two groups measured by counting number of pills taken in each group.
measure: active tuberculosis
time frame: 5 years
description: active tuberculosis within the study period. In case of suspected tuberculosis during the study the participant will be refered for examination by specialists. At 1 year follow-up participants will have a chest x-ray and physical examination by study doctor to screen for signs of active tuberculosis. If active tuberculosis is suspected further examinations will be performed by specialists.
measure: adverse events
time frame: 2 years
description: for both groups all adverse events will be recorded
arm group label: RPT-INH
arm group type: Experimental
description: Participants treated with weekly rifapentine and isoniazid for twelve weeks.
arm group label: control
arm group type: Active Comparator
description: Participants treated with daily isoniazid for six months
intervention type: Drug
intervention name: Rifapentine
description: Treatment with weekly rifapentine and isoniazid as Directly Observed Therapy in 12 weeks
arm group label: RPT-INH
other name: isoniazid
intervention type: Drug
intervention name: Isoniazid
description: Treatment with daily isoniazid in 6 months
arm group label: RPT-INH
arm group label: control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Christian Wejse, MD PHD
role: Principal Investigator
affiliation: Aarhus University Hospital
last name: Nina B Staerke, MD
phone: 004523647984
email: ninase@rm.dk
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Aarhus University Hospital
investigator full name: Nina Breinholt Stærke
investigator title: MD phd-student
mesh term: Tuberculosis
mesh term: Latent Tuberculosis
mesh term: Isoniazid
mesh term: Rifapentine
sharing ipd: No