Expand New Drugs for TB [endTB]

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

National Treatment Centre for Tuberculosis, Abovian, Armenia, Abovyan, Armenia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

This is a non-intervention observational study

Other

No applicable intervention; this is a secondary data analysis observational study.

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Partners in Health

Other

Collaborators

Epicentre
Harvard Medical School (HMS and HSDM)
Interactive Research and Development
Médecins Sans Frontières, France

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2019
Study completion: 2019
First posted: Aug 23, 2017
Registry last updated: Jun 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed