<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/NCT02984579</url>
  </required_header>
  <id_info>
    <org_study_id>YD7012-03</org_study_id>
    <nct_id>NCT02984579</nct_id>
  </id_info>
  <brief_title>Line Probe Assay Evaluation Study</brief_title>
  <acronym>YD</acronym>
  <official_title>Multi-center Study to Assess the Non-inferiority of YD REBA MTB-MDR® and Hain GenoType® MTBDRplus V2 Line Probe Assays Compared to Hain GenoType® MTBDRplus V1</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Foundation for Innovative New Diagnostics, Switzerland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Research Center Borstel</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute for Communicable Diseases, South Africa</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Institute of Tropical Medicine, Belgium</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Foundation for Innovative New Diagnostics, Switzerland</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multi-center, blinded study to determine the performance of the YD Diagnostic&#xD;
      Corporation (YD) REBA MTB-MDR® and Hain Genotype MTBDRplus V2 kit in a total of 600 clinical&#xD;
      isolates and 900 residual sputum samples from patients with symptoms of pulmonary TB (PTB)&#xD;
      and at risk of drug resistance. All testing was done on stored, de-identified leftover&#xD;
      samples.&#xD;
&#xD;
      The study involved three World Health Organization (WHO) Supranational Reference Laboratories&#xD;
      with well-characterized strain collections and access to sputum samples with significant&#xD;
      rates of drug resistance.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2015</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>INH/RIF Resistance Detection</measure>
    <time_frame>At the end of study 9-10 Months after the Study started</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Multi-Drug Resistant TB detection</measure>
    <time_frame>At the end of study 9-10 Months after the Study started</time_frame>
    <description>Is the subject resistant to both INH and RIF</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">888</enrollment>
  <condition>Multidrug-Resistant Tuberculosis</condition>
  <condition>Isoniazid Resistant Pulmonary Tuberculosis</condition>
  <condition>Rifampicin Resistant Tuberculosis</condition>
  <condition>Pulmonary Tuberculoses</condition>
  <arm_group>
    <arm_group_label>All Subjects</arm_group_label>
    <description>All strains in Phase 1 and all Sputum samples in Phase 2 were tested with Hain Genotype MTBDRplus V1, Hain Genotype MTBDRplus V2, and YD REBA MTB-MDR diagnostic tests.&#xD;
Investigators and Operators were blinded to all other results for a sample upon data entry.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>YD REBA MTB-MDR</intervention_name>
    <description>Conducted on stored, de-identified leftover samples. A line probe assay designed for detection of Multidrug-resistant tuberculosis (MDR-TB). The REBA MTB-MDR® assay is a qualitative in vitro test for the identification of Mycobacterium tuberculosis (MTB) complex and its susceptibility to rifampin and isoniazid from cultured samples and smear positive specimens.</description>
    <arm_group_label>All Subjects</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Hain Genotype MTBDRplus V1</intervention_name>
    <description>Conducted on stored, de-identified leftover samples. There is only one Line Probe Assay for molecular MTB drug resistance globally available, the GenoType® MTBDRplus V.1 from Hain Lifescience. This assay includes rpoB gene probes for Rifampin (RIF) resistance, katG gene probes for high level Isoniazid (INH) resistance, and inhA gene probes for determination of low level INH resistance</description>
    <arm_group_label>All Subjects</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Hain Genotype MTBDRplus V2</intervention_name>
    <description>Conducted on stored, de-identified leftover samples. An updated version of the Hain Genotype MTBDRplus V1 assay, the Genotype MTBDRplus V.2 line probe assay, showed increased sensitivity for MTB detection in the 2 studies published so far</description>
    <arm_group_label>All Subjects</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study consisted of two phases. In phase 1, each site was sent a different set of 200&#xD;
        clinical isolates from the Research and Training in Tropical Diseases and Institute for&#xD;
        Tropical Medicine collections (ITM).&#xD;
&#xD;
        In phase 2, samples from 274 patients recruited between Azerbaijan and Moldova were tested&#xD;
        in Germany, while samples from 214 (locally-recruited) patients were tested in South&#xD;
        Africa.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age over 18 years&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
          -  Patients evaluated for pulmonary TB&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>February 13, 2017</last_update_submitted>
  <last_update_submitted_qc>February 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tuberculosis</mesh_term>
    <mesh_term>Tuberculosis, Pulmonary</mesh_term>
    <mesh_term>Tuberculosis, Multidrug-Resistant</mesh_term>
  </condition_browse>
  <!-- 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/NCT02984579
org study id: YD7012-03
nct id: NCT02984579
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
This is a multi-center, blinded study to determine the performance of the YD Diagnostic
      Corporation (YD) REBA MTB-MDR® and Hain Genotype MTBDRplus V2 kit in a total of 600 clinical
      isolates and 900 residual sputum samples from patients with symptoms of pulmonary TB (PTB)
      and at risk of drug resistance. All testing was done on stored, de-identified leftover
      samples.

      The study involved three World Health Organization (WHO) Supranational Reference Laboratories
      with well-characterized strain collections and access to sputum samples with significant
      rates of drug resistance.
observational model: Other
time perspective: Cross-Sectional
measure: INH/RIF Resistance Detection
time frame: At the end of study 9-10 Months after the Study started
measure: Multi-Drug Resistant TB detection
time frame: At the end of study 9-10 Months after the Study started
description: Is the subject resistant to both INH and RIF
arm group label: All Subjects
description: All strains in Phase 1 and all Sputum samples in Phase 2 were tested with Hain Genotype MTBDRplus V1, Hain Genotype MTBDRplus V2, and YD REBA MTB-MDR diagnostic tests.
Investigators and Operators were blinded to all other results for a sample upon data entry.
intervention type: Device
intervention name: YD REBA MTB-MDR
description: Conducted on stored, de-identified leftover samples. A line probe assay designed for detection of Multidrug-resistant tuberculosis (MDR-TB). The REBA MTB-MDR® assay is a qualitative in vitro test for the identification of Mycobacterium tuberculosis (MTB) complex and its susceptibility to rifampin and isoniazid from cultured samples and smear positive specimens.
arm group label: All Subjects
intervention type: Device
intervention name: Hain Genotype MTBDRplus V1
description: Conducted on stored, de-identified leftover samples. There is only one Line Probe Assay for molecular MTB drug resistance globally available, the GenoType® MTBDRplus V.1 from Hain Lifescience. This assay includes rpoB gene probes for Rifampin (RIF) resistance, katG gene probes for high level Isoniazid (INH) resistance, and inhA gene probes for determination of low level INH resistance
arm group label: All Subjects
intervention type: Device
intervention name: Hain Genotype MTBDRplus V2
description: Conducted on stored, de-identified leftover samples. An updated version of the Hain Genotype MTBDRplus V1 assay, the Genotype MTBDRplus V.2 line probe assay, showed increased sensitivity for MTB detection in the 2 studies published so far
arm group label: All Subjects
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Tuberculosis
mesh term: Tuberculosis, Pulmonary
mesh term: Tuberculosis, Multidrug-Resistant