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Expand New Drugs for TB [endTB]

Completed
Conditions
Tuberculosis, Multidrug-Resistant
Registration Number
NCT03259269
Lead Sponsor
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
2804
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.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
End of treatment outcome20 - 24 months of treatment

Final outcomes: cured, treatment completed, treatment failed, lost to follow-up, died, not evaluated

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (16)

National Treatment Centre for Tuberculosis, Abovian, Armenia

🇦🇲

Abovyan, Armenia

National Institute of Diseases of the Chest and Hospital (NIDCH), Dhaka

🇧🇩

Dhaka, Bangladesh

Republican Research and Practical Centre for Pulmonology and Tuberculosis

🇧🇾

Minsk, Belarus

Bishoftu Hospital

🇪🇹

Bishoftu, Ethiopia

National Center for Tuberculosis and Lung Diseases

🇬🇪

Tbilisi, Georgia

RS Islam Jakarta Cempaka Putih

🇮🇩

Jakarta, Indonesia

National Research Center for Phthisionpulmonology

🇰🇿

Almaty, Kazakhstan

MSF Tuberculosis clinic, Mathare, Nairobi, Kenya

🇰🇪

Nairobi, Kenya

Kara-Suu District TB hospital

🇰🇬

Kara-Suu, Kyrgyzstan

Botshabelo Hospital

🇱🇸

Maseru, Lesotho

Scroll for more (6 remaining)
National Treatment Centre for Tuberculosis, Abovian, Armenia
🇦🇲Abovyan, Armenia

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