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Expand New Drugs for TB [endTB]

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ClinicalTrials.gov Identifier: NCT03259269
Recruitment Status : Recruiting
First Posted : August 23, 2017
Last Update Posted : August 31, 2018
Sponsor:
Collaborators:
Médecins Sans Frontières, France
Interactive Research and Development
Harvard Medical School
Epicentre
Information provided by (Responsible Party):
Partners in Health

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 Type : Observational
Estimated Enrollment : 2600 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 : February 9, 2016
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Bedaquiline

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.




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



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03259269


Contacts
Contact: Sarah McAnaw smcanaw@pih.org
Contact: Joshua Bogus jbogus@pih.org

Locations
Armenia
National Treatment Centre for Tuberculosis, Abovian, Armenia Recruiting
Abovyan, Armenia
Contact: Naira Khachatryan, MD       msff-erevan-medco@paris.msf.org   
Principal Investigator: Armen Hayrapetyan, MD         
Bangladesh
National Institute of Diseases of the Chest and Hospital (NIDCH), Dhaka Recruiting
Dhaka, Bangladesh
Contact: Hamidah Hussain, MBBS, MSc       hamidah.hussain@irdresearch.org   
Contact: Manzur ul-Alam, MD       manzur.ulalam@irdresearch.org   
Belarus
Republican Research and Practical Centre for Pulmonology and Tuberculosis Recruiting
Minsk, Belarus, 220053
Contact: Yoseph Tassew, MD       russia-medco@oca.msf.org   
Principal Investigator: Alena Skrahina, MD, PhD, DSc         
Ethiopia
Bishoftu Hospital Recruiting
Bishoftu, Ethiopia
Contact: Andargachew Kumsa, MD       AKumsa@pih.org   
Georgia
National Center for Tuberculosis and Lung Diseases Recruiting
Tbilisi, Georgia, 0101
Contact: Tinatin Kotrikadze, MD       msff-tbilisi-medco@paris.msf.org   
Principal Investigator: Zara Avaliani, MPH, PhD         
Indonesia
RS Islam Jakarta Cempaka Putih Not yet recruiting
Jakarta, Indonesia
Contact: Fauziah Asnely Putri, MD, MPH       fauziah.putri@irdresearch.org   
Kazakhstan
National Research Center for Phthisionpulmonology Recruiting
Almaty, Kazakhstan, 050010
Contact: Yerkebulan Algozhin, MD       ealgozhin@pih.org   
Principal Investigator: Elmira Berikova, MPH         
Kenya
MSF Tuberculosis clinic, Mathare, Nairobi, Kenya Recruiting
Nairobi, Kenya
Contact: Stephen Wanjala, MD       msff-nairobi-medco@paris.msf.org   
Principal Investigator: Maureen Kamene, MD, MBCHB         
Kyrgyzstan
Kara-Suu District TB hospital Recruiting
Kara-Suu, Kyrgyzstan
Contact: Hayk Karakozian, MD       MSFCH-Kyrgyzstan-Medco@geneva.msf.org   
Principal Investigator: Kadyrov Abdullaat, MD, PhD         
Lesotho
Botshabelo Hospital Recruiting
Maseru, Lesotho
Contact: Kwonjune Seung, MD       kjseung@pih.org   
Myanmar
Aung San Tuberculosis Hospital Not yet recruiting
Yangon, Myanmar
Contact: Jarmila Kliescikova, MD       myanmar-medco@oca.msf.org   
Principal Investigator: Si Tu Aung, MD         
Pakistan
The Indus Hospital, Karachi Recruiting
Karachi, Pakistan
Contact: Rabia Mashkoor, MD       rabia.mashkoor@ghd.ihn.org.pk   
Principal Investigator: Sana Adnan, MBBS, MSPH         
Institute of Chest Diseases, Kotri Recruiting
Kotri, Pakistan
Contact: Rabia Mashkoor, MD       rabia.mashkoor@ghd.ihn.org.pk   
Principal Investigator: Sana Adnan, MBBS, MSPH         
Gulab Devi Chest Hospital, Lahore Recruiting
Lahore, Pakistan
Contact: Rabia Mashkoor, MD       rabia.mashkoor@ghd.ihn.org.pk   
Principal Investigator: Sana Adnan, MBBS, MSPH         
Peru
Socios en Salud Not yet recruiting
Carabayllo, Peru
Contact: Carmen Contreras, BS       ccontreras_SES@pih.org   
Principal Investigator: Leonid Lecca, MD         
South Africa
King Dinuzulu Hospital Recruiting
Durban, South Africa
Contact: Munira Khan, MBCHB       munira.khan@irdresearch.org   
Sponsors and Collaborators
Partners in Health
Médecins Sans Frontières, France
Interactive Research and Development
Harvard Medical School
Epicentre

Additional Information:
Responsible Party: Partners in Health
ClinicalTrials.gov Identifier: NCT03259269     History of Changes
Other Study ID Numbers: Partners IRB 2015P001669
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018

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
Bedaquiline
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents