CClinicalTrials.gg
CompletedNCT03259269Updated Jun 13, 2022

Expand New Drugs for TB [endTB]

An observational study in Tuberculosis, Multidrug-Resistant, sponsored by Partners in Health. Completed at 16 sites in 14 countries. Per ClinicalTrials.gov, last updated 2022-06-13.

Sponsored by Partners in Health · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,804
Sex
All
01

Study summary

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.

02

Conditions studied

  • Tuberculosis, Multidrug-Resistant
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All MDR-TB patients started on treatment containing a new TB drug (bedaquiline or delamanid) and enrolled in clinical care within the endTB Project.

Inclusion criteria

  • Any patient who receives a treatment regimen containing bedaquiline or delamanid at an endTB site will be invited to participate in this observational study, regardless of age or gender.
  • Any patient who signs the study informed consent form will be included in the study.

Exclusion criteria

Exclusion Criteria:

  • Refusal to participate in the study.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,804 participants (actual)
Patient registry
No

Groups and cohorts

  • Bedaquiline and companion WHO Group 5 drugs

    Other: This is a non-intervention observational study

  • Delamanid and companion WHO Group 5 drugs

    Other: This is a non-intervention observational study

Interventions

  • OtherThis is a non-intervention observational study

    No applicable intervention; this is a secondary data analysis observational study.

05

What researchers measure

Primary outcomes

  1. End of treatment outcome

    Final outcomes: cured, treatment completed, treatment failed, lost to follow-up, died, not evaluated

    Time frame: 20 - 24 months of treatment

06

Study locations

16 sites
  • National Treatment Centre for Tuberculosis, Abovian, Armenia
    Abovyan, Armenia
  • National Institute of Diseases of the Chest and Hospital (NIDCH), Dhaka
    Dhaka, Bangladesh
  • Republican Research and Practical Centre for Pulmonology and Tuberculosis
    Minsk, 220053, Belarus
  • Bishoftu Hospital
    Bishoftu, Ethiopia
  • National Center for Tuberculosis and Lung Diseases
    Tbilisi, 0101, Georgia
  • RS Islam Jakarta Cempaka Putih
    Jakarta, Indonesia
  • National Research Center for Phthisionpulmonology
    Almaty, 050010, Kazakhstan
  • MSF Tuberculosis clinic, Mathare, Nairobi, Kenya
    Nairobi, Kenya
  • Kara-Suu District TB hospital
    Kara-Suu, Kyrgyzstan
  • Botshabelo Hospital
    Maseru, Lesotho
  • Aung San Tuberculosis Hospital
    Yangon, Myanmar
  • The Indus Hospital, Karachi
    Karachi, Pakistan
  • Institute of Chest Diseases, Kotri
    Kotri, Pakistan
  • Gulab Devi Chest Hospital, Lahore
    Lahore, Pakistan
  • Socios en Salud
    Carabayllo, Peru
  • King Dinuzulu Hospital
    Durban, South Africa
07

References and documents

Publications

  • 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. PubMed 35243494 ↗
  • 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. doi: 10.1093/cid/ciac347. PubMed 35028659 ↗
  • 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. PubMed 34140298 ↗
  • 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. doi: 10.1016/j.ijid.2022.05.004. PubMed 33823277 ↗
  • 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. doi: 10.1164/rccm.v203erratum6. Am J Respir Crit Care Med. 2022 Jul 15;206(2):231. doi: 10.1164/rccm.v206erratum2. PubMed 32706644 ↗
  • 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. doi: 10.1016/j.jhep.2022.04.012. PubMed 32147086 ↗
  • 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. doi: 10.1093/cid/ciac346. PubMed 31676905 ↗
  • 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. PubMed 31429722 ↗
  • 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. PubMed 33126944 ↗
  • 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. PubMed 33126943 ↗
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Registry details

Key details

Study ID
NCT03259269
Lead sponsor
Partners in Health
Collaborators
Médecins Sans Frontières, France, Interactive Research and Development, Harvard Medical School (HMS and HSDM), Epicentre
Responsible party
Sponsor
First posted
Aug 23, 2017
Start date
Apr 1, 2015
Primary completion
Sep 30, 2019
Completion
Dec 30, 2019
Last update
Jun 13, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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