<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/NCT03025516</url>
  </required_header>
  <id_info>
    <org_study_id>P07212-00</org_study_id>
    <nct_id>NCT03025516</nct_id>
  </id_info>
  <brief_title>Performance Evaluation of TB Breath- and Cough-testing Platforms</brief_title>
  <official_title>Performance Evaluation of Two Diagnostic Technologies for TB Detection Based Upon Breath Testing</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Find</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Universidad Peruana Cayetano Heredia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Cape Town</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Find</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This will be a prospective, multicentre study conducted to evaluate the diagnostic accuracy&#xD;
      of two TB breath-based technologies independently of the manufacturers. Assay error and&#xD;
      failure rates and device operational characteristics will also be assessed during this study.&#xD;
      Participants will be enrolled in this study in line with FIND sample banking activities.&#xD;
      Results from index tests will not be used to make clinical decisions. Participation in this&#xD;
      study will not alter the standard of care.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 29, 2017</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2017</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>Microbiological TB Diagnosis</measure>
    <time_frame>8 weeks</time_frame>
    <description>TB diagnosed by AFB smear microscopy or by one of two MGIT (liquid) or LJ (solid) cultures on enrollment or follow-up sputum sample</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">360</enrollment>
  <condition>Pulmonary TB</condition>
  <condition>Diagnoses Diseases</condition>
  <arm_group>
    <arm_group_label>Adults with pulmonary TB symptoms</arm_group_label>
    <description>All patients will be tested with both the reference and index TB diagnostic tests. Index test results will not be used to inform case management.&#xD;
All samples must be collected before the patient starts any form of TB treatment. Patients will be randomized to receive either the TB Breathalyser or AeonoseTM on Day 1, and will be tested with the remaining breath-test on Day 2. A follow-up evaluation will be required after 8 weeks for all patients who do not have microbiologic confirmation of TB (smear or culture). Two additional breath samples may also be collected upon follow-up.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Rapid Biosensor Systems (RBS) TB Breathalyser</intervention_name>
    <description>Rapid Biosensor Systems (RBS) recently developed a portable, non-invasive, rapid TB diagnostic 'Breathalyser' capable of diagnosing TB in patient breath samples collected while patients cough (Figure 1). The TB Breathalyser comprises a disposable, single-use sample collection tube and a multi-use reader. At the bottom of the collection tube is a glass bio-sensor coated with a biochemical sensor that is formulated to react with TB bacilli. Patients cough into the collection tube after nebulization with 0.9% saline solution. Following sample collection, the tube is placed into the reader, where a diode laser interrogates the biochemical coating in the sample collection tube and reports the presence of TB bacilli. The entire process takes about two minutes.</description>
    <arm_group_label>Adults with pulmonary TB symptoms</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>eNose AeonoseTM</intervention_name>
    <description>The eNose Company has also developed a hand-held, non-invasive rapid TB diagnostic 'electronic nose' (AeonoseTM) for TB detection based upon analysis of exhaled breath. After the device has been calibrated, the patient is instructed to breathe into the device through a mouthpiece for 5 minutes. Within the device is a micro-hotplate, metal-oxide sensor which behaves as a semiconductor at high temperature. Redox-reactions occurring at the sensor surface result in changes in resistance, with results read and interpreted by a phone application to confirm the presence of MTB.</description>
    <arm_group_label>Adults with pulmonary TB symptoms</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      All consenting patients are expected to provide the following samples: 2x breath/cough&#xD;
      samples, which will be collected directly into enclosed diagnostic devices and destroyed&#xD;
      immediately following diagnosis; blood samples for HIV testing, which will be de-identified&#xD;
      and stored until study completion; urine samples; and 3x sputum samples, collected at&#xD;
      enrollment and during an 8-week follow-up, de-identified and used for liquid culture, solid&#xD;
      culture, AFB smear, and DNA extraction for Xpert testing. Except for the breath samples, all&#xD;
      samples will be de-identified and stored until study completion.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All adult patients who have symptoms consistent with pulmonary TB presenting to health&#xD;
        facilities during study period. Patients will be asked by study or non-study clinicians or&#xD;
        staff if they would be interested in participating in the study. Interested individuals&#xD;
        will be referred to study personnel for additional information and screening, if&#xD;
        appropriate, samples will be obtained following the informed consent process.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Symptoms suggesting pulmonary TB, i.e. persistent cough (generally &gt; 3 weeks or as per&#xD;
             local definition of TB suspect) and at least one other finding listed below:&#xD;
&#xD;
               1. Persistent cough&#xD;
&#xD;
               2. Fever&#xD;
&#xD;
               3. Malaise&#xD;
&#xD;
               4. Recent weight loss&#xD;
&#xD;
               5. Night sweats&#xD;
&#xD;
               6. Contact w/ active case&#xD;
&#xD;
               7. Hemoptysis&#xD;
&#xD;
               8. Chest pain&#xD;
&#xD;
               9. Loss of appetite&#xD;
&#xD;
              10. Other [specify]&#xD;
&#xD;
          -  Provision of informed consent to sample collection, banking and HIV and breath-based&#xD;
             assay testing&#xD;
&#xD;
          -  Production of adequate quantity of sputum (sputum induction whenever possible)&#xD;
&#xD;
          -  Adult age (&gt;18 years old)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants receiving any anti-tuberculosis medication, including fluoroquinolone and&#xD;
             aminoglycosides in the 60 days prior to enrolment.&#xD;
&#xD;
          -  Participants with ONLY extra-pulmonary disease will be excluded.&#xD;
&#xD;
          -  Participants for whom complete follow-up and a clear final diagnosis are judged to be&#xD;
             difficult (e.g. residents elsewhere or about to move).&#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>Timothy C Rodwell, MD, PhD, MPH</last_name>
    <role>Study Director</role>
    <affiliation>Find</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sonia Arafah</last_name>
    <phone>+41 (22) 710 05 90</phone>
    <email>sonia.arafah@finddx.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Nolungile Clinic, University of Cape Town</name>
      <address>
        <city>Cape Town</city>
        <zip>7700</zip>
        <country>South Africa</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shireen Surtie</last_name>
    </contact>
    <contact_backup>
      <last_name>Pamela Jordan</last_name>
    </contact_backup>
  </location>
  <location_countries>
    <country>South Africa</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>July 18, 2017</last_update_submitted>
  <last_update_submitted_qc>July 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 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, Pulmonary</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/NCT03025516
org study id: P07212-00
nct id: NCT03025516
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
This will be a prospective, multicentre study conducted to evaluate the diagnostic accuracy
      of two TB breath-based technologies independently of the manufacturers. Assay error and
      failure rates and device operational characteristics will also be assessed during this study.
      Participants will be enrolled in this study in line with FIND sample banking activities.
      Results from index tests will not be used to make clinical decisions. Participation in this
      study will not alter the standard of care.
observational model: Cohort
time perspective: Prospective
measure: Microbiological TB Diagnosis
time frame: 8 weeks
description: TB diagnosed by AFB smear microscopy or by one of two MGIT (liquid) or LJ (solid) cultures on enrollment or follow-up sputum sample
arm group label: Adults with pulmonary TB symptoms
description: All patients will be tested with both the reference and index TB diagnostic tests. Index test results will not be used to inform case management.
All samples must be collected before the patient starts any form of TB treatment. Patients will be randomized to receive either the TB Breathalyser or AeonoseTM on Day 1, and will be tested with the remaining breath-test on Day 2. A follow-up evaluation will be required after 8 weeks for all patients who do not have microbiologic confirmation of TB (smear or culture). Two additional breath samples may also be collected upon follow-up.
intervention type: Device
intervention name: Rapid Biosensor Systems (RBS) TB Breathalyser
description: Rapid Biosensor Systems (RBS) recently developed a portable, non-invasive, rapid TB diagnostic 'Breathalyser' capable of diagnosing TB in patient breath samples collected while patients cough (Figure 1). The TB Breathalyser comprises a disposable, single-use sample collection tube and a multi-use reader. At the bottom of the collection tube is a glass bio-sensor coated with a biochemical sensor that is formulated to react with TB bacilli. Patients cough into the collection tube after nebulization with 0.9% saline solution. Following sample collection, the tube is placed into the reader, where a diode laser interrogates the biochemical coating in the sample collection tube and reports the presence of TB bacilli. The entire process takes about two minutes.
arm group label: Adults with pulmonary TB symptoms
intervention type: Device
intervention name: eNose AeonoseTM
description: The eNose Company has also developed a hand-held, non-invasive rapid TB diagnostic 'electronic nose' (AeonoseTM) for TB detection based upon analysis of exhaled breath. After the device has been calibrated, the patient is instructed to breathe into the device through a mouthpiece for 5 minutes. Within the device is a micro-hotplate, metal-oxide sensor which behaves as a semiconductor at high temperature. Redox-reactions occurring at the sensor surface result in changes in resistance, with results read and interpreted by a phone application to confirm the presence of MTB.
arm group label: Adults with pulmonary TB symptoms
All consenting patients are expected to provide the following samples: 2x breath/cough
      samples, which will be collected directly into enclosed diagnostic devices and destroyed
      immediately following diagnosis; blood samples for HIV testing, which will be de-identified
      and stored until study completion; urine samples; and 3x sputum samples, collected at
      enrollment and during an 8-week follow-up, de-identified and used for liquid culture, solid
      culture, AFB smear, and DNA extraction for Xpert testing. Except for the breath samples, all
      samples will be de-identified and stored until study completion.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Timothy C Rodwell, MD, PhD, MPH
role: Study Director
affiliation: Find
last name: Sonia Arafah
phone: +41 (22) 710 05 90
email: sonia.arafah@finddx.org
facility: 
status: Recruiting
contact: 
contact backup: 
country: South Africa
responsible party type: Sponsor
mesh term: Tuberculosis, Pulmonary
sharing ipd: No