<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/NCT02251327</url>
  </required_header>
  <id_info>
    <org_study_id>NA_0008420</org_study_id>
    <secondary_id>NA_0008420</secondary_id>
    <nct_id>NCT02251327</nct_id>
  </id_info>
  <brief_title>Feasibility and Accuracy of a Novel Xpert Cartridge</brief_title>
  <acronym>(XpertDST)</acronym>
  <official_title>Feasibility and Accuracy of a Novel Xpert Cartridge for Rapid Molecular Detection of Drug Resistant Mycobacterium Tuberculosis in Sputum</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Boston Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Consenting adults will be interviewed for demographic and medical information, and then will&#xD;
      be asked to provide two expectorated sputum specimens. In the study laboratory, sputa will be&#xD;
      tested using conventional and investigational diagnostic tests for tuberculosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  For each of isoniazid, ofloxacin, moxifloxacin, amikacin, and kanamycin: sensitivity and&#xD;
           specificity of the investigational Xpert test for detection of drug resistance, using&#xD;
           phenotypic drug susceptibility testing as the reference comparator&#xD;
&#xD;
        -  For each of isoniazid, ofloxacin, moxifloxacin, amikacin, and kanamycin: sensitivity and&#xD;
           specificity of the investigational Xpert test for detection of drug resistance, using&#xD;
           mycobacterial DNA sequencing as the reference comparator&#xD;
&#xD;
        -  Sensitivity and specificity, for detection of M. tuberculosis in sputum, of the&#xD;
           investigational Xpert test and of the conventional Xpert MTB/RIF test, using culture as&#xD;
           the reference comparator&#xD;
&#xD;
        -  Diagnostic yield (for tuberculosis) of the investigational Xpert test and of the&#xD;
           conventional Xpert MTB/RIF test&#xD;
&#xD;
        -  For the investigational Xpert test, the proportion of specimens with a result of&#xD;
           'invalid' and the proportion of specimens with a result of 'error'&#xD;
&#xD;
        -  Proportion of study participants with M. tuberculosis detected in sputum&#xD;
&#xD;
        -  Proportion of participants with drug resistant tuberculosis, by drug resistance pattern&#xD;
           and by tuberculosis categorization (new case or not new case)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 4, 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">June 15, 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Sensitivity and specificity</measure>
    <time_frame>10 months</time_frame>
    <description>sensitivity and specificity of the investigational Xpert DST test for detection of drug resistance, using phenotypic drug susceptibility testing, mycobacterial DNA sequencing, and MTB/RIF test as the reference comparator</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diagnostic yield (for tuberculosis) of the investigational Xpert test and of the conventional Xpert MTB/RIF test</measure>
    <time_frame>10 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the proportion of specimens with a result of 'invalid' and the proportion of specimens with a result of 'error'</measure>
    <time_frame>10 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of study participants with TB and DRTB</measure>
    <time_frame>10 months</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">401</enrollment>
  <condition>Tuberculosis</condition>
  <arm_group>
    <arm_group_label>Case detection group</arm_group_label>
    <description>Suspected or confirmed new pulmonary tuberculosis cases who have received anti-tuberculosis drugs for less than 3 (three) days and provide up to two expectorated sputum specimens. One investigational Xpert DST test and one Xpert MTB/RIF test were performed directly on the same sputum specimen; in addition, one smear microscopy test, one mycobacterial liquid culture, and one solid culture were performed after digestion and decontamination of sputum.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Drug resistance risk group</arm_group_label>
    <description>Confirmed pulmonary tuberculosis cases with documented rifampin resistance, who have received anti-tuberculosis drugs for 31 days or less and/or history of prior tuberculosis PLUS ongoing signs and/or cases with symptoms of pulmonary tuberculosis PLUS suspected drug resistance and provide up to two expectorated sputum specimens. One investigational Xpert DST test and one Xpert MTB/RIF test were performed directly on the same sputum specimen; in addition, one smear microscopy test, one mycobacterial liquid culture, and one solid culture were performed after digestion and decontamination of sputum.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Investigational Xpert DST test</intervention_name>
    <description>One investigational test performed directly on the same sputum specimen.</description>
    <arm_group_label>Case detection group</arm_group_label>
    <arm_group_label>Drug resistance risk group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adults with clinical signs and/or symptoms of pulmonary TB&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals must meet all of the following inclusion criteria in order to be eligible&#xD;
             to participate:&#xD;
&#xD;
               -  Age ≥ 19 years (age of majority) if enrolled in South Korea; age ≥ 18 years (age&#xD;
                  of majority) if enrolled in China&#xD;
&#xD;
               -  Provision of informed consent&#xD;
&#xD;
               -  Clinical signs and/or symptoms suggestive of pulmonary tuberculosis&#xD;
&#xD;
               -  Meets one of the following criteria:&#xD;
&#xD;
        A. Suspected or confirmed new pulmonary tuberculosis case who has received&#xD;
        anti-tuberculosis drugs for less than 3 (three) days (target enrollment for Group A is&#xD;
        approximately 50 participants).&#xD;
&#xD;
        B. Confirmed pulmonary tuberculosis with documented rifampin resistance, who has received&#xD;
        anti-tuberculosis drugs for 31 days or less C. History of prior tuberculosis PLUS ongoing&#xD;
        signs and/or symptoms of pulmonary tuberculosis PLUS suspected drug resistance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to provide a sputum specimen&#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>August 2018</verification_date>
  <study_first_submitted>September 23, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 29, 2014</study_first_posted>
  <last_update_submitted>August 20, 2018</last_update_submitted>
  <last_update_submitted_qc>August 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2018</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>
  </condition_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/NCT02251327
org study id: NA_0008420
secondary id: NA_0008420
nct id: NCT02251327
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Consenting adults will be interviewed for demographic and medical information, and then will
      be asked to provide two expectorated sputum specimens. In the study laboratory, sputa will be
      tested using conventional and investigational diagnostic tests for tuberculosis.
-  For each of isoniazid, ofloxacin, moxifloxacin, amikacin, and kanamycin: sensitivity and
           specificity of the investigational Xpert test for detection of drug resistance, using
           phenotypic drug susceptibility testing as the reference comparator

        -  For each of isoniazid, ofloxacin, moxifloxacin, amikacin, and kanamycin: sensitivity and
           specificity of the investigational Xpert test for detection of drug resistance, using
           mycobacterial DNA sequencing as the reference comparator

        -  Sensitivity and specificity, for detection of M. tuberculosis in sputum, of the
           investigational Xpert test and of the conventional Xpert MTB/RIF test, using culture as
           the reference comparator

        -  Diagnostic yield (for tuberculosis) of the investigational Xpert test and of the
           conventional Xpert MTB/RIF test

        -  For the investigational Xpert test, the proportion of specimens with a result of
           'invalid' and the proportion of specimens with a result of 'error'

        -  Proportion of study participants with M. tuberculosis detected in sputum

        -  Proportion of participants with drug resistant tuberculosis, by drug resistance pattern
           and by tuberculosis categorization (new case or not new case)
observational model: Cohort
time perspective: Prospective
measure: Sensitivity and specificity
time frame: 10 months
description: sensitivity and specificity of the investigational Xpert DST test for detection of drug resistance, using phenotypic drug susceptibility testing, mycobacterial DNA sequencing, and MTB/RIF test as the reference comparator
measure: Diagnostic yield (for tuberculosis) of the investigational Xpert test and of the conventional Xpert MTB/RIF test
time frame: 10 months
measure: the proportion of specimens with a result of 'invalid' and the proportion of specimens with a result of 'error'
time frame: 10 months
measure: Proportion of study participants with TB and DRTB
time frame: 10 months
arm group label: Case detection group
description: Suspected or confirmed new pulmonary tuberculosis cases who have received anti-tuberculosis drugs for less than 3 (three) days and provide up to two expectorated sputum specimens. One investigational Xpert DST test and one Xpert MTB/RIF test were performed directly on the same sputum specimen; in addition, one smear microscopy test, one mycobacterial liquid culture, and one solid culture were performed after digestion and decontamination of sputum.
arm group label: Drug resistance risk group
description: Confirmed pulmonary tuberculosis cases with documented rifampin resistance, who have received anti-tuberculosis drugs for 31 days or less and/or history of prior tuberculosis PLUS ongoing signs and/or cases with symptoms of pulmonary tuberculosis PLUS suspected drug resistance and provide up to two expectorated sputum specimens. One investigational Xpert DST test and one Xpert MTB/RIF test were performed directly on the same sputum specimen; in addition, one smear microscopy test, one mycobacterial liquid culture, and one solid culture were performed after digestion and decontamination of sputum.
intervention type: Device
intervention name: Investigational Xpert DST test
description: One investigational test performed directly on the same sputum specimen.
arm group label: Case detection group
arm group label: Drug resistance risk group
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
sharing ipd: No