Expand New Drugs for TB [endTB]
Sponsor
Partners in Health (Other)
Overall Status
Completed
CT.gov ID
NCT03259269
Collaborator
Médecins Sans Frontières, France (Other), Interactive Research and Development (Other), Harvard Medical School (HMS and HSDM) (Other), Epicentre (Other)
2,804
16
57
175.3
3.1
Study Details
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 | Phase |
|---|---|---|
|
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
:
Apr 1, 2015
Actual Primary Completion Date
:
Sep 30, 2019
Actual Study Completion Date
:
Dec 30, 2019
Arms and Interventions
| Arm | 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
- End of treatment outcome [20 - 24 months of treatment]
Final outcomes: cured, treatment completed, treatment failed, lost to follow-up, died, not evaluated
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Treatment Centre for Tuberculosis, Abovian, Armenia | Abovyan | Armenia | ||
| 2 | National Institute of Diseases of the Chest and Hospital (NIDCH), Dhaka | Dhaka | Bangladesh | ||
| 3 | Republican Research and Practical Centre for Pulmonology and Tuberculosis | Minsk | Belarus | 220053 | |
| 4 | Bishoftu Hospital | Bishoftu | Ethiopia | ||
| 5 | National Center for Tuberculosis and Lung Diseases | Tbilisi | Georgia | 0101 | |
| 6 | RS Islam Jakarta Cempaka Putih | Jakarta | Indonesia | ||
| 7 | National Research Center for Phthisionpulmonology | Almaty | Kazakhstan | 050010 | |
| 8 | MSF Tuberculosis clinic, Mathare, Nairobi, Kenya | Nairobi | Kenya | ||
| 9 | Kara-Suu District TB hospital | Kara-Suu | Kyrgyzstan | ||
| 10 | Botshabelo Hospital | Maseru | Lesotho | ||
| 11 | Aung San Tuberculosis Hospital | Yangon | Myanmar | ||
| 12 | The Indus Hospital, Karachi | Karachi | Pakistan | ||
| 13 | Institute of Chest Diseases, Kotri | Kotri | Pakistan | ||
| 14 | Gulab Devi Chest Hospital, Lahore | Lahore | Pakistan | ||
| 15 | Socios en Salud | Carabayllo | Peru | ||
| 16 | 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
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- 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.
- 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]
- 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]
- 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.
- 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.
- 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.
- 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 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.
- 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:
Aug 23, 2017
Last Update Posted:
Jun 13, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: