Expand New Drugs for TB [endTB]

• ClinicalTrials.gov Identifier: NCT03259269
• Recruitment Status: Completed
• First Posted: August 23, 2017
• Last Update Posted: June 13, 2022
• Sponsor: Partners in Health
• Collaborators: Médecins Sans Frontières, France; Interactive Research and Development; Harvard Medical School (HMS and HSDM); Epicentre
• Information provided by (Responsible Party): Partners in Health

Study Description

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.

Condition or disease	Intervention/treatment
Tuberculosis, Multidrug-Resistant	Other: This is a non-intervention observational study

Study Design

• Study Type: Observational
• Actual Enrollment: 2804 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: endTB (Expand New Drugs for TB) Observational Study: Treatment of MDR-TB With Regimens Containing Bedaquiline or Delamanid
• Actual Study Start Date: April 1, 2015
• Actual Primary Completion Date: September 30, 2019
• Actual Study Completion Date: December 30, 2019

Groups and Cohorts

Group/Cohort	Intervention/treatment
Bedaquiline and companion WHO Group 5 drugs	Other: This is a non-intervention observational study; No applicable intervention; this is a secondary data analysis observational study.
Delamanid and companion WHO Group 5 drugs	Other: This is a non-intervention observational study; No applicable intervention; this is a secondary data analysis observational study.

Outcome Measures

Primary Outcome Measures :

1. End of treatment outcome [ Time Frame: 20 - 24 months of treatment ]
   Final outcomes: cured, treatment completed, treatment failed, lost to follow-up, died, not evaluated

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: 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.

Criteria

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:

• Refusal to participate in the study.

Contacts and Locations

Locations

Armenia

National Treatment Centre for Tuberculosis, Abovian, Armenia

Abovyan, Armenia

Bangladesh

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

Dhaka, Bangladesh

Belarus

Republican Research and Practical Centre for Pulmonology and Tuberculosis

Minsk, Belarus, 220053

Ethiopia

Bishoftu Hospital

Bishoftu, Ethiopia

Georgia

National Center for Tuberculosis and Lung Diseases

Tbilisi, Georgia, 0101

Indonesia

RS Islam Jakarta Cempaka Putih

Jakarta, Indonesia

Kazakhstan

National Research Center for Phthisionpulmonology

Almaty, Kazakhstan, 050010

Kenya

MSF Tuberculosis clinic, Mathare, Nairobi, Kenya

Nairobi, Kenya

Kyrgyzstan

Kara-Suu District TB hospital

Kara-Suu, Kyrgyzstan

Lesotho

Botshabelo Hospital

Maseru, Lesotho

Myanmar

Aung San Tuberculosis Hospital

Yangon, Myanmar

Pakistan

The Indus Hospital, Karachi

Karachi, Pakistan

Institute of Chest Diseases, Kotri

Kotri, Pakistan

Gulab Devi Chest Hospital, Lahore

Lahore, Pakistan

Peru

Socios en Salud

Carabayllo, Peru

South Africa

King Dinuzulu Hospital

Durban, South Africa

Sponsors and Collaborators

Partners in Health

Médecins Sans Frontières, France

Interactive Research and Development

Harvard Medical School (HMS and HSDM)

Epicentre

More Information

Additional Information:

endTB Project website 

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

• Responsible Party: Partners in Health
• ClinicalTrials.gov Identifier: NCT03259269
• Other Study ID Numbers: Partners IRB 2015P001669
• First Posted: August 23, 2017
• Last Update Posted: June 13, 2022
• Last Verified: June 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Tuberculosis; Tuberculosis, Multidrug-Resistant; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections