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Expand New Drugs for TB [endTB]

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03259269
Recruitment Status : Active, not recruiting
First Posted : August 23, 2017
Last Update Posted : March 25, 2019
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

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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



Information from the National Library of Medicine

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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


Locations
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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
Epicentre

Additional Information:
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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: March 25, 2019
Last Verified: March 2019

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

Additional relevant MeSH terms:
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Tuberculosis
Tuberculosis, Multidrug-Resistant
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bedaquiline
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents