<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/NCT03794284</url>
  </required_header>
  <id_info>
    <org_study_id>VereMTB_v2_24_10_2018</org_study_id>
    <nct_id>NCT03794284</nct_id>
  </id_info>
  <brief_title>Multiplex PCR -Microarray-based Assay in the Detection of Mycobacterium</brief_title>
  <official_title>Performance of a Multiplex PCR -Microarray-based Assay in the Detection of Mycobacterium Tuberculosis and Non-tuberculous Mycobacterium Species in Smear-positive Pulmonary Clinical Specimens</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Prince of Wales Hospital, Shatin, Hong Kong</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Chinese University of Hong Kong</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>
      The study will use the VereMTB tool for rapid diagnosis of TB or non-tuberculous&#xD;
      mycobacterium (NTM) pulmonary infections in hospitalised patients, with positive results in&#xD;
      acid-fast bacilli smears, which are emerging in many regions of the world.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Delay in diagnosis and treatment of tuberculosis was common in hospitalised patients all&#xD;
      around the world, and was associated with poorer outcomes, including respiratory failure and&#xD;
      mortality. Rapid and accurate tools for diagnosis of TB is of great importance in initial&#xD;
      treatment and for better treatment outcomes. Other than TB, non-tuberculous mycobacterium&#xD;
      (NTM) pulmonary infections are emerging in many regions of the world. These bacterium are&#xD;
      more common to be found in respiratory specimens than MTB. With similar clinical presentation&#xD;
      of NTM pulmonary infections and pulmonary TB, misdiagnosis of NTM pulmonary infections to&#xD;
      pulmonary TB would lead to unnecessary intake of anti-TB medications and delay of the&#xD;
      initiation of corresponding treatment.&#xD;
&#xD;
      This test aims to detect MTB as well differentiate the NTM species involved in pulmonary&#xD;
      infections simultaneously using VereMTB.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 28, 2019</start_date>
  <completion_date type="Actual">July 31, 2022</completion_date>
  <primary_completion_date type="Actual">July 31, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>diagnostic test correlation</measure>
    <time_frame>6 months from the date of first recruitment</time_frame>
    <description>Sensitivity, specificity, positive predictive value, and negative predictive value, will be calculated to determine accuracy of VereMTB, in diagnosing MTB and NTM</description>
  </primary_outcome>
  <enrollment type="Actual">46</enrollment>
  <condition>Tuberculosis</condition>
  <condition>Non-Tuberculous Mycobacterial Pneumonia</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>VereMTB</intervention_name>
    <description>At least 2 mL of patient's expectorated or induced sputum would be collected for VereMTB assay and their clinical data would be retrieved for analysis use.</description>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      At least 2mL of sputum&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients admitted to the Prince of Wales Hospital with suspected pulmonary TB with positive&#xD;
        AFB smears will be identified by Infectious Diseases physicians and recruited accordingly.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 18 or older&#xD;
&#xD;
          2. One or more symptoms compatible with mycobacterial pulmonary infections, including&#xD;
             fever, cough, sputum production,hemoptysis dyspnea, chest pain and weight loss&#xD;
&#xD;
          3. One or more sputum samples with positive AFB smear&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Receiving anti-mycobacterial treatment for more than one week&#xD;
&#xD;
          2. Refusal to consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chung Yan Grace Lui</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chinese University of Hong Kong</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Prince of Wales Hospital</name>
      <address>
        <city>Sha Tin</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <reference>
    <citation>GBD Tuberculosis Collaborators. The global burden of tuberculosis: results from the Global Burden of Disease Study 2015. Lancet Infect Dis. 2018 Mar;18(3):261-284. doi: 10.1016/S1473-3099(17)30703-X. Epub 2017 Dec 7.</citation>
    <PMID>29223583</PMID>
  </reference>
  <reference>
    <citation>Lui G, Wong RY, Li F, Lee MK, Lai RW, Li TC, Kam JK, Lee N. High mortality in adults hospitalized for active tuberculosis in a low HIV prevalence setting. PLoS One. 2014 Mar 18;9(3):e92077. doi: 10.1371/journal.pone.0092077. eCollection 2014.</citation>
    <PMID>24642794</PMID>
  </reference>
  <reference>
    <citation>Bhurayanontachai R, Maneenil K. Factors influencing development and mortality of acute respiratory failure in hospitalized patient with active pulmonary tuberculosis: a 10-year retrospective review. J Thorac Dis. 2016 Jul;8(7):1721-30. doi: 10.21037/jtd.2016.06.22.</citation>
    <PMID>27499962</PMID>
  </reference>
  <reference>
    <citation>Namkoong H, Kurashima A, Morimoto K, Hoshino Y, Hasegawa N, Ato M, Mitarai S. Epidemiology of Pulmonary Nontuberculous Mycobacterial Disease, Japan. Emerg Infect Dis. 2016 Jun;22(6):1116-7. doi: 10.3201/eid2206.151086. No abstract available.</citation>
    <PMID>27191735</PMID>
  </reference>
  <reference>
    <citation>Kim HS, Lee Y, Lee S, Kim YA, Sun YK. Recent trends in clinically significant nontuberculous Mycobacteria isolates at a Korean general hospital. Ann Lab Med. 2014 Jan;34(1):56-9. doi: 10.3343/alm.2014.34.1.56. Epub 2013 Dec 6.</citation>
    <PMID>24422197</PMID>
  </reference>
  <reference>
    <citation>Chien JY, Lai CC, Sheng WH, Yu CJ, Hsueh PR. Pulmonary infection and colonization with nontuberculous mycobacteria, Taiwan, 2000-2012. Emerg Infect Dis. 2014 Aug;20(8):1382-5. doi: 10.3201/eid2008.131673.</citation>
    <PMID>25062534</PMID>
  </reference>
  <reference>
    <citation>Lan R, Yang C, Lan L, Ou J, Qiao K, Liu F, Gao Q. Mycobacterium tuberculosis and non-tuberculous mycobacteria isolates from HIV-infected patients in Guangxi, China. Int J Tuberc Lung Dis. 2011 Dec;15(12):1669-75. doi: 10.5588/ijtld.11.0036.</citation>
    <PMID>22118176</PMID>
  </reference>
  <reference>
    <citation>McCarthy KD, Cain KP, Winthrop KL, Udomsantisuk N, Lan NT, Sar B, Kimerling ME, Kanara N, Lynen L, Monkongdee P, Tasaneeyapan T, Varma JK. Nontuberculous mycobacterial disease in patients with HIV in Southeast Asia. Am J Respir Crit Care Med. 2012 May 1;185(9):981-8. doi: 10.1164/rccm.201107-1327OC. Epub 2012 Feb 16.</citation>
    <PMID>22345581</PMID>
  </reference>
  <reference>
    <citation>Cabibbe AM, Miotto P, Moure R, Alcaide F, Feuerriegel S, Pozzi G, Nikolayevskyy V, Drobniewski F, Niemann S, Reither K, Cirillo DM; TM-REST Consortium; TB-CHILD Consortium. Lab-on-Chip-Based Platform for Fast Molecular Diagnosis of Multidrug-Resistant Tuberculosis. J Clin Microbiol. 2015 Dec;53(12):3876-80. doi: 10.1128/JCM.01824-15. Epub 2015 Aug 5.</citation>
    <PMID>26246486</PMID>
  </reference>
  <reference>
    <citation>Lazzeri E, Santoro F, Oggioni MR, Iannelli F, Pozzi G. Novel primer-probe sets for detection and identification of mycobacteria by PCR-microarray assay. J Clin Microbiol. 2012 Nov;50(11):3777-9. doi: 10.1128/JCM.02300-12. Epub 2012 Sep 12.</citation>
    <PMID>22972818</PMID>
  </reference>
  <reference>
    <citation>Hoefsloot W, van Ingen J, Andrejak C, Angeby K, Bauriaud R, Bemer P, Beylis N, Boeree MJ, Cacho J, Chihota V, Chimara E, Churchyard G, Cias R, Daza R, Daley CL, Dekhuijzen PN, Domingo D, Drobniewski F, Esteban J, Fauville-Dufaux M, Folkvardsen DB, Gibbons N, Gomez-Mampaso E, Gonzalez R, Hoffmann H, Hsueh PR, Indra A, Jagielski T, Jamieson F, Jankovic M, Jong E, Keane J, Koh WJ, Lange B, Leao S, Macedo R, Mannsaker T, Marras TK, Maugein J, Milburn HJ, Mlinko T, Morcillo N, Morimoto K, Papaventsis D, Palenque E, Paez-Pena M, Piersimoni C, Polanova M, Rastogi N, Richter E, Ruiz-Serrano MJ, Silva A, da Silva MP, Simsek H, van Soolingen D, Szabo N, Thomson R, Tortola Fernandez T, Tortoli E, Totten SE, Tyrrell G, Vasankari T, Villar M, Walkiewicz R, Winthrop KL, Wagner D; Nontuberculous Mycobacteria Network European Trials Group. The geographic diversity of nontuberculous mycobacteria isolated from pulmonary samples: an NTM-NET collaborative study. Eur Respir J. 2013 Dec;42(6):1604-13. doi: 10.1183/09031936.00149212. Epub 2013 Apr 18.</citation>
    <PMID>23598956</PMID>
  </reference>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 7, 2019</study_first_posted>
  <last_update_submitted>August 7, 2022</last_update_submitted>
  <last_update_submitted_qc>August 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Grace Lui</investigator_full_name>
    <investigator_title>Assistant Professor and Head, Division of Infectious Diseases</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tuberculosis</mesh_term>
    <mesh_term>Mycobacterium Infections</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/NCT03794284
org study id: VereMTB_v2_24_10_2018
nct id: NCT03794284
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study will use the VereMTB tool for rapid diagnosis of TB or non-tuberculous
      mycobacterium (NTM) pulmonary infections in hospitalised patients, with positive results in
      acid-fast bacilli smears, which are emerging in many regions of the world.
Delay in diagnosis and treatment of tuberculosis was common in hospitalised patients all
      around the world, and was associated with poorer outcomes, including respiratory failure and
      mortality. Rapid and accurate tools for diagnosis of TB is of great importance in initial
      treatment and for better treatment outcomes. Other than TB, non-tuberculous mycobacterium
      (NTM) pulmonary infections are emerging in many regions of the world. These bacterium are
      more common to be found in respiratory specimens than MTB. With similar clinical presentation
      of NTM pulmonary infections and pulmonary TB, misdiagnosis of NTM pulmonary infections to
      pulmonary TB would lead to unnecessary intake of anti-TB medications and delay of the
      initiation of corresponding treatment.

      This test aims to detect MTB as well differentiate the NTM species involved in pulmonary
      infections simultaneously using VereMTB.
observational model: Case-Only
time perspective: Prospective
measure: diagnostic test correlation
time frame: 6 months from the date of first recruitment
description: Sensitivity, specificity, positive predictive value, and negative predictive value, will be calculated to determine accuracy of VereMTB, in diagnosing MTB and NTM
intervention type: Diagnostic Test
intervention name: VereMTB
description: At least 2 mL of patient's expectorated or induced sputum would be collected for VereMTB assay and their clinical data would be retrieved for analysis use.
At least 2mL of sputum
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Chung Yan Grace Lui
role: Principal Investigator
affiliation: Chinese University of Hong Kong
facility: 
country: Hong Kong
citation: GBD Tuberculosis Collaborators. The global burden of tuberculosis: results from the Global Burden of Disease Study 2015. Lancet Infect Dis. 2018 Mar;18(3):261-284. doi: 10.1016/S1473-3099(17)30703-X. Epub 2017 Dec 7.
PMID: 29223583
citation: Lui G, Wong RY, Li F, Lee MK, Lai RW, Li TC, Kam JK, Lee N. High mortality in adults hospitalized for active tuberculosis in a low HIV prevalence setting. PLoS One. 2014 Mar 18;9(3):e92077. doi: 10.1371/journal.pone.0092077. eCollection 2014.
PMID: 24642794
citation: Bhurayanontachai R, Maneenil K. Factors influencing development and mortality of acute respiratory failure in hospitalized patient with active pulmonary tuberculosis: a 10-year retrospective review. J Thorac Dis. 2016 Jul;8(7):1721-30. doi: 10.21037/jtd.2016.06.22.
PMID: 27499962
citation: Namkoong H, Kurashima A, Morimoto K, Hoshino Y, Hasegawa N, Ato M, Mitarai S. Epidemiology of Pulmonary Nontuberculous Mycobacterial Disease, Japan. Emerg Infect Dis. 2016 Jun;22(6):1116-7. doi: 10.3201/eid2206.151086. No abstract available.
PMID: 27191735
citation: Kim HS, Lee Y, Lee S, Kim YA, Sun YK. Recent trends in clinically significant nontuberculous Mycobacteria isolates at a Korean general hospital. Ann Lab Med. 2014 Jan;34(1):56-9. doi: 10.3343/alm.2014.34.1.56. Epub 2013 Dec 6.
PMID: 24422197
citation: Chien JY, Lai CC, Sheng WH, Yu CJ, Hsueh PR. Pulmonary infection and colonization with nontuberculous mycobacteria, Taiwan, 2000-2012. Emerg Infect Dis. 2014 Aug;20(8):1382-5. doi: 10.3201/eid2008.131673.
PMID: 25062534
citation: Lan R, Yang C, Lan L, Ou J, Qiao K, Liu F, Gao Q. Mycobacterium tuberculosis and non-tuberculous mycobacteria isolates from HIV-infected patients in Guangxi, China. Int J Tuberc Lung Dis. 2011 Dec;15(12):1669-75. doi: 10.5588/ijtld.11.0036.
PMID: 22118176
citation: McCarthy KD, Cain KP, Winthrop KL, Udomsantisuk N, Lan NT, Sar B, Kimerling ME, Kanara N, Lynen L, Monkongdee P, Tasaneeyapan T, Varma JK. Nontuberculous mycobacterial disease in patients with HIV in Southeast Asia. Am J Respir Crit Care Med. 2012 May 1;185(9):981-8. doi: 10.1164/rccm.201107-1327OC. Epub 2012 Feb 16.
PMID: 22345581
citation: Cabibbe AM, Miotto P, Moure R, Alcaide F, Feuerriegel S, Pozzi G, Nikolayevskyy V, Drobniewski F, Niemann S, Reither K, Cirillo DM; TM-REST Consortium; TB-CHILD Consortium. Lab-on-Chip-Based Platform for Fast Molecular Diagnosis of Multidrug-Resistant Tuberculosis. J Clin Microbiol. 2015 Dec;53(12):3876-80. doi: 10.1128/JCM.01824-15. Epub 2015 Aug 5.
PMID: 26246486
citation: Lazzeri E, Santoro F, Oggioni MR, Iannelli F, Pozzi G. Novel primer-probe sets for detection and identification of mycobacteria by PCR-microarray assay. J Clin Microbiol. 2012 Nov;50(11):3777-9. doi: 10.1128/JCM.02300-12. Epub 2012 Sep 12.
PMID: 22972818
citation: Hoefsloot W, van Ingen J, Andrejak C, Angeby K, Bauriaud R, Bemer P, Beylis N, Boeree MJ, Cacho J, Chihota V, Chimara E, Churchyard G, Cias R, Daza R, Daley CL, Dekhuijzen PN, Domingo D, Drobniewski F, Esteban J, Fauville-Dufaux M, Folkvardsen DB, Gibbons N, Gomez-Mampaso E, Gonzalez R, Hoffmann H, Hsueh PR, Indra A, Jagielski T, Jamieson F, Jankovic M, Jong E, Keane J, Koh WJ, Lange B, Leao S, Macedo R, Mannsaker T, Marras TK, Maugein J, Milburn HJ, Mlinko T, Morcillo N, Morimoto K, Papaventsis D, Palenque E, Paez-Pena M, Piersimoni C, Polanova M, Rastogi N, Richter E, Ruiz-Serrano MJ, Silva A, da Silva MP, Simsek H, van Soolingen D, Szabo N, Thomson R, Tortola Fernandez T, Tortoli E, Totten SE, Tyrrell G, Vasankari T, Villar M, Walkiewicz R, Winthrop KL, Wagner D; Nontuberculous Mycobacteria Network European Trials Group. The geographic diversity of nontuberculous mycobacteria isolated from pulmonary samples: an NTM-NET collaborative study. Eur Respir J. 2013 Dec;42(6):1604-13. doi: 10.1183/09031936.00149212. Epub 2013 Apr 18.
PMID: 23598956
responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: Grace Lui
investigator title: Assistant Professor and Head, Division of Infectious Diseases
mesh term: Tuberculosis
mesh term: Mycobacterium Infections
sharing ipd: No