Expand New Drugs for TB [endTB]

NCT03259269 | Completed

• 1 other identifier: Partners IRB 2015P001669
• Study Type: observational
• Target: 2,804
• Locations: 14 countries
• Sites: 16

Brief 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.

Conditions

Tuberculosis, Multidrug-Resistant

Outcome Measures

Primary Outcomes (1)

• End of treatment outcome

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

  20 - 24 months of treatment

Study Arms (2)

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

This is a non-intervention observational study OTHER

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

Bedaquiline and companion WHO Group 5 drugs; Delamanid and companion WHO Group 5 drugs

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Refusal to participate in the study.

Sponsors & Collaborators

• Partners in Health: lead
• Médecins Sans Frontières, France: collaborator
• Interactive Research and Development: collaborator
• Harvard Medical School (HMS and HSDM): collaborator
• Epicentre: collaborator

Study Sites (16)

National Treatment Centre for Tuberculosis, Abovian, Armenia

Abovyan, Armenia

Location

National Institute of Diseases of the Chest and Hospital (NIDCH), Dhaka

Dhaka, Bangladesh

Location

Republican Research and Practical Centre for Pulmonology and Tuberculosis

Minsk, 220053, Belarus

Location

Aung San Tuberculosis Hospital

Yangon, Burma

Location

Bishoftu Hospital

Bishoftu, Ethiopia

Location

National Center for Tuberculosis and Lung Diseases

Tbilisi, 0101, Georgia

Location

RS Islam Jakarta Cempaka Putih

Jakarta, Indonesia

Location

National Research Center for Phthisionpulmonology

Almaty, 050010, Kazakhstan

Location

MSF Tuberculosis clinic, Mathare, Nairobi, Kenya

Nairobi, Kenya

Location

Kara-Suu District TB hospital

Kara Suu, Kyrgyzstan

Location

Botshabelo Hospital

Maseru, Lesotho

Location

The Indus Hospital, Karachi

Karachi, Pakistan

Location

Institute of Chest Diseases, Kotri

Kotri, Pakistan

Location

Gulab Devi Chest Hospital, Lahore

Lahore, Pakistan

Location

Socios en Salud

Carabayllo, Peru

Location

King Dinuzulu Hospital

Durban, South Africa

Location

Related Publications (10)

• 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 BACKGROUND

• 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.

  PMID: 35028659 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 33823277 BACKGROUND

• 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.

  PMID: 32706644 BACKGROUND

• 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.

  PMID: 32147086 BACKGROUND

• 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.

  PMID: 31676905 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Related Links

• endTB Project website

MeSH Terms

Conditions

Tuberculosis, Multidrug-Resistant

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2017
• First Posted: August 23, 2017
• Study Start: April 1, 2015
• Primary Completion: September 30, 2019
• Study Completion: December 30, 2019
• Last Updated: June 13, 2022

Record last verified: 2022-06

Locations

PE (1); KY (1); ET (1); BE (1); BU (1); ID (1); AR (1); GE (1); KE (1); BA (1); LE (1); PA (3); KA (1); ZA (1)