<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/NCT03259269</url>
  </required_header>
  <id_info>
    <org_study_id>Partners IRB 2015P001669</org_study_id>
    <nct_id>NCT03259269</nct_id>
  </id_info>
  <brief_title>Expand New Drugs for TB [endTB]</brief_title>
  <official_title>endTB (Expand New Drugs for TB) Observational Study: Treatment of MDR-TB With Regimens Containing Bedaquiline or Delamanid</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Partners in Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Médecins Sans Frontières, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Interactive Research and Development</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Harvard Medical School (HMS and HSDM)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Epicentre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Partners in Health</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This observational study will examine the safety and efficacy of bedaquiline and delamanid&#xD;
      used (individually, not together) in routine, multidrug regimens for treatment of MDR-TB. The&#xD;
      information gathered in this study will inform doctors how best to use these TB drugs in the&#xD;
      future.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2015</start_date>
  <completion_date type="Actual">December 30, 2019</completion_date>
  <primary_completion_date type="Actual">September 30, 2019</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>End of treatment outcome</measure>
    <time_frame>20 - 24 months of treatment</time_frame>
    <description>Final outcomes: cured, treatment completed, treatment failed, lost to follow-up, died, not evaluated</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">2804</enrollment>
  <condition>Tuberculosis, Multidrug-Resistant</condition>
  <arm_group>
    <arm_group_label>Bedaquiline and companion WHO Group 5 drugs</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Delamanid and companion WHO Group 5 drugs</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>This is a non-intervention observational study</intervention_name>
    <description>No applicable intervention; this is a secondary data analysis observational study.</description>
    <arm_group_label>Bedaquiline and companion WHO Group 5 drugs</arm_group_label>
    <arm_group_label>Delamanid and companion WHO Group 5 drugs</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All MDR-TB patients started on treatment containing a new TB drug (bedaquiline or&#xD;
        delamanid) and enrolled in clinical care within the endTB Project.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any patient who receives a treatment regimen containing bedaquiline or delamanid at an&#xD;
             endTB site will be invited to participate in this observational study, regardless of&#xD;
             age or gender.&#xD;
&#xD;
          -  Any patient who signs the study informed consent form will be included in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal to participate in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>National Treatment Centre for Tuberculosis, Abovian, Armenia</name>
      <address>
        <city>Abovyan</city>
        <country>Armenia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Institute of Diseases of the Chest and Hospital (NIDCH), Dhaka</name>
      <address>
        <city>Dhaka</city>
        <country>Bangladesh</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Republican Research and Practical Centre for Pulmonology and Tuberculosis</name>
      <address>
        <city>Minsk</city>
        <zip>220053</zip>
        <country>Belarus</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bishoftu Hospital</name>
      <address>
        <city>Bishoftu</city>
        <country>Ethiopia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Center for Tuberculosis and Lung Diseases</name>
      <address>
        <city>Tbilisi</city>
        <zip>0101</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>RS Islam Jakarta Cempaka Putih</name>
      <address>
        <city>Jakarta</city>
        <country>Indonesia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Research Center for Phthisionpulmonology</name>
      <address>
        <city>Almaty</city>
        <zip>050010</zip>
        <country>Kazakhstan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MSF Tuberculosis clinic, Mathare, Nairobi, Kenya</name>
      <address>
        <city>Nairobi</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kara-Suu District TB hospital</name>
      <address>
        <city>Kara-Suu</city>
        <country>Kyrgyzstan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Botshabelo Hospital</name>
      <address>
        <city>Maseru</city>
        <country>Lesotho</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aung San Tuberculosis Hospital</name>
      <address>
        <city>Yangon</city>
        <country>Myanmar</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Indus Hospital, Karachi</name>
      <address>
        <city>Karachi</city>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute of Chest Diseases, Kotri</name>
      <address>
        <city>Kotri</city>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gulab Devi Chest Hospital, Lahore</name>
      <address>
        <city>Lahore</city>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Socios en Salud</name>
      <address>
        <city>Carabayllo</city>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>King Dinuzulu Hospital</name>
      <address>
        <city>Durban</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Armenia</country>
    <country>Bangladesh</country>
    <country>Belarus</country>
    <country>Ethiopia</country>
    <country>Georgia</country>
    <country>Indonesia</country>
    <country>Kazakhstan</country>
    <country>Kenya</country>
    <country>Kyrgyzstan</country>
    <country>Lesotho</country>
    <country>Myanmar</country>
    <country>Pakistan</country>
    <country>Peru</country>
    <country>South Africa</country>
  </location_countries>
  <link>
    <url>http://endtb.org/</url>
    <description>endTB Project website</description>
  </link>
  <reference>
    <citation>Huerga H, Khan U, Bastard M, Mitnick CD, Lachenal N, Khan PY, Seung KJ, Melikyan N, Ahmed S, Rich ML, Varaine F, Osso E, Rashitov M, Salahuddin N, Salia G, Sanchez E, Serobyan A, Rafi Siddiqui M, Grium Tefera D, Vetushko D, Yeghiazaryan L, Holtzman D, Islam S, Kumsa A, Jacques Leblanc G, Leonovich O, Mamsa S, Manzur-Ul-Alam M, Myint Z, Padayachee S, Franke MF, Hewison C. Safety and Effectiveness Outcomes From a 14-Country Cohort of Patients With Multi-Drug Resistant Tuberculosis Treated Concomitantly With Bedaquiline, Delamanid, and Other Second-Line Drugs. Clin Infect Dis. 2022 Oct 12;75(8):1307-1314. doi: 10.1093/cid/ciac176.</citation>
    <PMID>35243494</PMID>
  </reference>
  <reference>
    <citation>Hewison C, Khan U, Bastard M, Lachenal N, Coutisson S, Osso E, Ahmed S, Khan P, Franke MF, Rich ML, Varaine F, Melikyan N, Seung KJ, Adenov M, Adnan S, Danielyan N, Islam S, Janmohamed A, Karakozian H, Kamene Kimenye M, Kirakosyan O, Kholikulov B, Krisnanda A, Kumsa A, Leblanc G, Lecca L, Nkuebe M, Mamsa S, Padayachee S, Thit P, Mitnick CD, Huerga H. Safety of Treatment Regimens Containing Bedaquiline and Delamanid in the endTB Cohort. Clin Infect Dis. 2022 Sep 29;75(6):1006-1013. doi: 10.1093/cid/ciac019. Erratum In: Clin Infect Dis. 2023 Feb 18;76(4):779.</citation>
    <PMID>35028659</PMID>
  </reference>
  <reference>
    <citation>Khan PY, Franke MF, Hewison C, Seung KJ, Huerga H, Atwood S, Ahmed S, Khan M, Sultana T, Manzur-Ul-Alam M, Vo LNQ, Lecca L, Yae K, Kozhabekov S, Tamirat M, Gelin A, Vilbrun SC, Kikvidze M, Faqirzai J, Kadyrov A, Skrahina A, Mesic A, Avagyan N, Bastard M, Rich ML, Khan U, Mitnick CD. All-oral longer regimens are effective for the management of multidrug-resistant tuberculosis in high-burden settings. Eur Respir J. 2022 Jan 20;59(1):2004345. doi: 10.1183/13993003.04345-2020. Print 2022 Jan.</citation>
    <PMID>34140298</PMID>
  </reference>
  <reference>
    <citation>Maretbayeva SM, Rakisheva AS, Adenov MM, Yeraliyeva LT, Algozhin YZ, Stambekova AT, Berikova EA, Yedilbayev A, Rich ML, Seung KJ, Issayeva AM. Culture conversion at six months in patients receiving bedaquiline- and delamanid-containing regimens for the treatment of multidrug-resistant tuberculosis. Int J Infect Dis. 2021 Dec;113 Suppl 1:S91-S95. doi: 10.1016/j.ijid.2021.03.075. Epub 2021 Apr 3. Erratum In: Int J Infect Dis. 2022 Aug;121:105.</citation>
    <PMID>33823277</PMID>
  </reference>
  <reference>
    <citation>Franke MF, Khan P, Hewison C, Khan U, Huerga H, Seung KJ, Rich ML, Zarli K, Samieva N, Oyewusi L, Nair P, Mudassar M, Melikyan N, Lenggogeni P, Lecca L, Kumsa A, Khan M, Islam S, Hussein K, Docteur W, Chumburidze N, Berikova E, Atshemyan H, Atwood S, Alam M, Ahmed S, Bastard M, Mitnick CD. Culture Conversion in Patients Treated with Bedaquiline and/or Delamanid. A Prospective Multicountry Study. Am J Respir Crit Care Med. 2021 Jan 1;203(1):111-119. doi: 10.1164/rccm.202001-0135OC. Erratum In: Am J Respir Crit Care Med. 2021 Apr 1;203(7):929. Am J Respir Crit Care Med. 2022 Jul 15;206(2):231.</citation>
    <PMID>32706644</PMID>
  </reference>
  <reference>
    <citation>Seung KJ, Franke MF, Hewison C, Huerga H, Khan U, Mitnick CD; end TB Study Group. High prevalence of hepatitis C infection among multidrug-resistant tuberculosis patients. J Hepatol. 2020 May;72(5):1028-1029. doi: 10.1016/j.jhep.2019.10.018. Epub 2020 Mar 6. No abstract available. Erratum In: J Hepatol. 2022 Aug;77(2):583.</citation>
    <PMID>32147086</PMID>
  </reference>
  <reference>
    <citation>Seung KJ, Khan P, Franke MF, Ahmed S, Aiylchiev S, Alam M, Putri FA, Bastard M, Docteur W, Gottlieb G, Hewison C, Islam S, Khachatryan N, Kotrikadze T, Khan U, Kumsa A, Lecca L, Tassew YM, Melikyan N, Naing YY, Oyewusi L, Rich M, Wanjala S, Yedilbayev A, Huerga H, Mitnick CD. Culture Conversion at 6 Months in Patients Receiving Delamanid-containing Regimens for the Treatment of Multidrug-resistant Tuberculosis. Clin Infect Dis. 2020 Jul 11;71(2):415-418. doi: 10.1093/cid/ciz1084. Erratum In: Clin Infect Dis. 2023 Jan 13;76(2):374.</citation>
    <PMID>31676905</PMID>
  </reference>
  <reference>
    <citation>Khan U, Huerga H, Khan AJ, Mitnick CD, Hewison C, Varaine F, Bastard M, Rich M, Franke MF, Atwood S, Khan PY, Seung KJ. The endTB observational study protocol: treatment of MDR-TB with bedaquiline or delamanid containing regimens. BMC Infect Dis. 2019 Aug 20;19(1):733. doi: 10.1186/s12879-019-4378-4.</citation>
    <PMID>31429722</PMID>
  </reference>
  <reference>
    <citation>Lachenal N, Hewison C, Mitnick C, Lomtadze N, Coutisson S, Osso E, Ahmed S, Leblanc G, Islam S, Atshemyan H, Nair P, Kholikulov B, Aiylchiev S, Zarli K, Adnan S, Krisnanda A, Padayachee S, Stambekova A, Sahabutdinova Y, de Guadalupe S, Moreno P, Kumsa A, Reshid A, Makaka J, Abebe S, Melikyan N, Seung KJ, Khan U, Khan P, Huerga H, Rich M, Varaine F. Setting up pharmacovigilance based on available endTB Project data for bedaquiline. Int J Tuberc Lung Dis. 2020 Oct 1;24(10):1087-1094. doi: 10.5588/ijtld.20.0115.</citation>
    <PMID>33126944</PMID>
  </reference>
  <reference>
    <citation>Seung KJ, Khan U, Varaine F, Ahmed S, Bastard M, Cloez S, Damtew D, Franke MF, Herboczek K, Huerga H, Islam S, Karakozian H, Khachatryan N, Kliesckova J, Khan AJ, Khan M, Khan P, Kotrikadze T, Lachenal N, Lecca L, Lenggogeni P, Maretbayeva S, Melikyan N, Mesic A, Mitnick CD, Mofolo M, Perrin C, Richard M, Tassew YM, Telnov A, Vilbrun SC, Wanjala S, Rich ML, Hewison C. Introducing new and repurposed TB drugs: the endTB experience. Int J Tuberc Lung Dis. 2020 Oct 1;24(10):1081-1086. doi: 10.5588/ijtld.20.0141.</citation>
    <PMID>33126943</PMID>
  </reference>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>June 9, 2022</last_update_submitted>
  <last_update_submitted_qc>June 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 13, 2022</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, 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/NCT03259269
org study id: Partners IRB 2015P001669
nct id: NCT03259269
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This observational study will examine the safety and efficacy of bedaquiline and delamanid
      used (individually, not together) in routine, multidrug regimens for treatment of MDR-TB. The
      information gathered in this study will inform doctors how best to use these TB drugs in the
      future.
observational model: Cohort
time perspective: Prospective
measure: End of treatment outcome
time frame: 20 - 24 months of treatment
description: Final outcomes: cured, treatment completed, treatment failed, lost to follow-up, died, not evaluated
arm group label: Bedaquiline and companion WHO Group 5 drugs
arm group label: Delamanid and companion WHO Group 5 drugs
intervention type: Other
intervention name: This is a non-intervention observational study
description: No applicable intervention; this is a secondary data analysis observational study.
arm group label: Bedaquiline and companion WHO Group 5 drugs
arm group label: Delamanid and companion WHO Group 5 drugs
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Armenia
country: Bangladesh
country: Belarus
country: Ethiopia
country: Georgia
country: Indonesia
country: Kazakhstan
country: Kenya
country: Kyrgyzstan
country: Lesotho
country: Myanmar
country: Pakistan
country: Peru
country: South Africa
url: http://endtb.org/
description: endTB Project website
citation: Huerga H, Khan U, Bastard M, Mitnick CD, Lachenal N, Khan PY, Seung KJ, Melikyan N, Ahmed S, Rich ML, Varaine F, Osso E, Rashitov M, Salahuddin N, Salia G, Sanchez E, Serobyan A, Rafi Siddiqui M, Grium Tefera D, Vetushko D, Yeghiazaryan L, Holtzman D, Islam S, Kumsa A, Jacques Leblanc G, Leonovich O, Mamsa S, Manzur-Ul-Alam M, Myint Z, Padayachee S, Franke MF, Hewison C. Safety and Effectiveness Outcomes From a 14-Country Cohort of Patients With Multi-Drug Resistant Tuberculosis Treated Concomitantly With Bedaquiline, Delamanid, and Other Second-Line Drugs. Clin Infect Dis. 2022 Oct 12;75(8):1307-1314. doi: 10.1093/cid/ciac176.
PMID: 35243494
citation: Hewison C, Khan U, Bastard M, Lachenal N, Coutisson S, Osso E, Ahmed S, Khan P, Franke MF, Rich ML, Varaine F, Melikyan N, Seung KJ, Adenov M, Adnan S, Danielyan N, Islam S, Janmohamed A, Karakozian H, Kamene Kimenye M, Kirakosyan O, Kholikulov B, Krisnanda A, Kumsa A, Leblanc G, Lecca L, Nkuebe M, Mamsa S, Padayachee S, Thit P, Mitnick CD, Huerga H. Safety of Treatment Regimens Containing Bedaquiline and Delamanid in the endTB Cohort. Clin Infect Dis. 2022 Sep 29;75(6):1006-1013. doi: 10.1093/cid/ciac019. Erratum In: Clin Infect Dis. 2023 Feb 18;76(4):779.
PMID: 35028659
citation: Khan PY, Franke MF, Hewison C, Seung KJ, Huerga H, Atwood S, Ahmed S, Khan M, Sultana T, Manzur-Ul-Alam M, Vo LNQ, Lecca L, Yae K, Kozhabekov S, Tamirat M, Gelin A, Vilbrun SC, Kikvidze M, Faqirzai J, Kadyrov A, Skrahina A, Mesic A, Avagyan N, Bastard M, Rich ML, Khan U, Mitnick CD. All-oral longer regimens are effective for the management of multidrug-resistant tuberculosis in high-burden settings. Eur Respir J. 2022 Jan 20;59(1):2004345. doi: 10.1183/13993003.04345-2020. Print 2022 Jan.
PMID: 34140298
citation: Maretbayeva SM, Rakisheva AS, Adenov MM, Yeraliyeva LT, Algozhin YZ, Stambekova AT, Berikova EA, Yedilbayev A, Rich ML, Seung KJ, Issayeva AM. Culture conversion at six months in patients receiving bedaquiline- and delamanid-containing regimens for the treatment of multidrug-resistant tuberculosis. Int J Infect Dis. 2021 Dec;113 Suppl 1:S91-S95. doi: 10.1016/j.ijid.2021.03.075. Epub 2021 Apr 3. Erratum In: Int J Infect Dis. 2022 Aug;121:105.
PMID: 33823277
citation: Franke MF, Khan P, Hewison C, Khan U, Huerga H, Seung KJ, Rich ML, Zarli K, Samieva N, Oyewusi L, Nair P, Mudassar M, Melikyan N, Lenggogeni P, Lecca L, Kumsa A, Khan M, Islam S, Hussein K, Docteur W, Chumburidze N, Berikova E, Atshemyan H, Atwood S, Alam M, Ahmed S, Bastard M, Mitnick CD. Culture Conversion in Patients Treated with Bedaquiline and/or Delamanid. A Prospective Multicountry Study. Am J Respir Crit Care Med. 2021 Jan 1;203(1):111-119. doi: 10.1164/rccm.202001-0135OC. Erratum In: Am J Respir Crit Care Med. 2021 Apr 1;203(7):929. Am J Respir Crit Care Med. 2022 Jul 15;206(2):231.
PMID: 32706644
citation: Seung KJ, Franke MF, Hewison C, Huerga H, Khan U, Mitnick CD; end TB Study Group. High prevalence of hepatitis C infection among multidrug-resistant tuberculosis patients. J Hepatol. 2020 May;72(5):1028-1029. doi: 10.1016/j.jhep.2019.10.018. Epub 2020 Mar 6. No abstract available. Erratum In: J Hepatol. 2022 Aug;77(2):583.
PMID: 32147086
citation: Seung KJ, Khan P, Franke MF, Ahmed S, Aiylchiev S, Alam M, Putri FA, Bastard M, Docteur W, Gottlieb G, Hewison C, Islam S, Khachatryan N, Kotrikadze T, Khan U, Kumsa A, Lecca L, Tassew YM, Melikyan N, Naing YY, Oyewusi L, Rich M, Wanjala S, Yedilbayev A, Huerga H, Mitnick CD. Culture Conversion at 6 Months in Patients Receiving Delamanid-containing Regimens for the Treatment of Multidrug-resistant Tuberculosis. Clin Infect Dis. 2020 Jul 11;71(2):415-418. doi: 10.1093/cid/ciz1084. Erratum In: Clin Infect Dis. 2023 Jan 13;76(2):374.
PMID: 31676905
citation: Khan U, Huerga H, Khan AJ, Mitnick CD, Hewison C, Varaine F, Bastard M, Rich M, Franke MF, Atwood S, Khan PY, Seung KJ. The endTB observational study protocol: treatment of MDR-TB with bedaquiline or delamanid containing regimens. BMC Infect Dis. 2019 Aug 20;19(1):733. doi: 10.1186/s12879-019-4378-4.
PMID: 31429722
citation: Lachenal N, Hewison C, Mitnick C, Lomtadze N, Coutisson S, Osso E, Ahmed S, Leblanc G, Islam S, Atshemyan H, Nair P, Kholikulov B, Aiylchiev S, Zarli K, Adnan S, Krisnanda A, Padayachee S, Stambekova A, Sahabutdinova Y, de Guadalupe S, Moreno P, Kumsa A, Reshid A, Makaka J, Abebe S, Melikyan N, Seung KJ, Khan U, Khan P, Huerga H, Rich M, Varaine F. Setting up pharmacovigilance based on available endTB Project data for bedaquiline. Int J Tuberc Lung Dis. 2020 Oct 1;24(10):1087-1094. doi: 10.5588/ijtld.20.0115.
PMID: 33126944
citation: Seung KJ, Khan U, Varaine F, Ahmed S, Bastard M, Cloez S, Damtew D, Franke MF, Herboczek K, Huerga H, Islam S, Karakozian H, Khachatryan N, Kliesckova J, Khan AJ, Khan M, Khan P, Kotrikadze T, Lachenal N, Lecca L, Lenggogeni P, Maretbayeva S, Melikyan N, Mesic A, Mitnick CD, Mofolo M, Perrin C, Richard M, Tassew YM, Telnov A, Vilbrun SC, Wanjala S, Rich ML, Hewison C. Introducing new and repurposed TB drugs: the endTB experience. Int J Tuberc Lung Dis. 2020 Oct 1;24(10):1081-1086. doi: 10.5588/ijtld.20.0141.
PMID: 33126943
responsible party type: Sponsor
mesh term: Tuberculosis
mesh term: Tuberculosis, Multidrug-Resistant