Expand New Drugs for TB [endTB]

Partners in Health

Status: Completed

Conditions: Tuberculosis, Multidrug-Resistant

Treatments: Other: This is a non-intervention observational study

Study type: Observational

Funder types: Other

Identifiers

NCT03259269

Partners IRB 2015P001669

Details and patient eligibility

About

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.

Enrollment: 2,804 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

2,804 participants in 2 patient groups

Bedaquiline and companion WHO Group 5 drugs

Treatment:

Other: This is a non-intervention observational study

Delamanid and companion WHO Group 5 drugs

Treatment:

Other: This is a non-intervention observational study