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Clinical Trials/NCT03259269
NCT03259269CompletedNot Applicable

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

Partners in Health16 sites in 14 countries2,804 target enrollmentStarted: April 1, 2015Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
2,804
Locations
16
Primary Endpoint
End of treatment outcome
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (16)

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