Expand New Drugs for TB [endTB]

Tuberculosis, Multidrug-Resistant Clinical Trial

Official title:

endTB (Expand New Drugs for TB) Observational Study: Treatment of MDR-TB With Regimens Containing Bedaquiline or Delamanid

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03259269
• Other study ID #: Partners IRB 2015P001669
• Status: Completed
• Start date: April 1, 2015
• Est. completion date: December 30, 2019

Study information

• Verified date: June 2022
• Source: Partners in Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2804
• Est. completion date: December 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Tuberculosis
• Tuberculosis, Multidrug-Resistant

Intervention

Other:
• This is a non-intervention observational study
No applicable intervention; this is a secondary data analysis observational study.

Locations

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

Sponsors (5)

Lead Sponsor	Collaborator
Partners in Health	Epicentre, Harvard Medical School (HMS and HSDM), Interactive Research and Development, Médecins Sans Frontières, France

Countries where clinical trial is conducted

Armenia,  Bangladesh,  Belarus,  Ethiopia,  Georgia,  Indonesia,  Kazakhstan,  Kenya,  Kyrgyzstan,  Lesotho,  Myanmar,  Pakistan,  Peru,  South Africa, 

References & Publications (10)

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. — View 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, Kimenye MK, Kirakosyan O, Kholikulov B, Krisnanda A, Kumsa A, Leblanc G, Lecca L, Nkuebe M, Mamsa S, Padayachee S, Thit P, Mitnick CD, Huerga H; endTB study observational study team. Safety of treatment regimens containing bedaquiline and delamanid in the endTB cohort. Clin Infect Dis. 2022 Jan 13. pii: ciac019. doi: 10.1093/cid/ciac019. [Epub ahead of print] — View 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, Sánchez E, Serobyan A, Siddiqui MR, Tefera DG, Vetushko D, Yeghiazaryan L, Holtzman D, Islam S, Kumsa A, Leblanc GJ, Leonovich O, Mamsa S, Manzur-Ul-Alam M, Myint Z, Padayachee S, Franke MF, Hewison C; endTB study observational study team. 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 Mar 4. pii: ciac176. doi: 10.1093/cid/ciac176. [Epub ahead of print] — View 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). pii: 2004345. doi: 10.1183/13993003.04345-2020. Print 2022 Jan. — View 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. — View 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. — View 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 May 22;121:105. — View 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. Erratum in: J Hepatol. 2022 May 14;:. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	End of treatment outcome	Final outcomes: cured, treatment completed, treatment failed, lost to follow-up, died, not evaluated	20 - 24 months of treatment

External Links

•   endTB Project website