Expand New Drugs for TB [endTB]

June 9, 2022 updated by: Partners in Health

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

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 Overview

Study Type

Observational

Enrollment (Actual)

2804

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Abovyan, Armenia
        • National Treatment Centre for Tuberculosis, Abovian, Armenia
      • Dhaka, Bangladesh
        • National Institute of Diseases of the Chest and Hospital (NIDCH), Dhaka
      • Minsk, Belarus, 220053
        • Republican Research and Practical Centre for Pulmonology and Tuberculosis
      • Bishoftu, Ethiopia
        • Bishoftu hospital
      • Tbilisi, Georgia, 0101
        • National Center for Tuberculosis and Lung Diseases
      • Jakarta, Indonesia
        • RS Islam Jakarta Cempaka Putih
      • Almaty, Kazakhstan, 050010
        • National Research Center for Phthisionpulmonology
      • Nairobi, Kenya
        • MSF Tuberculosis clinic, Mathare, Nairobi, Kenya
      • Kara-Suu, Kyrgyzstan
        • Kara-Suu District TB hospital
      • Maseru, Lesotho
        • Botshabelo Hospital
      • Yangon, Myanmar
        • Aung San Tuberculosis Hospital
      • Karachi, Pakistan
        • The Indus Hospital, Karachi
      • Kotri, Pakistan
        • Institute of Chest Diseases, Kotri
      • Lahore, Pakistan
        • Gulab Devi Chest Hospital, Lahore
      • Carabayllo, Peru
        • Socios En Salud
      • Durban, South Africa
        • King Dinuzulu Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Bedaquiline and companion WHO Group 5 drugs
No applicable intervention; this is a secondary data analysis observational study.
Delamanid and companion WHO Group 5 drugs
No applicable intervention; this is a secondary data analysis observational study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
20 - 24 months of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2015

Primary Completion (Actual)

September 30, 2019

Study Completion (Actual)

December 30, 2019

Study Registration Dates

First Submitted

August 21, 2017

First Submitted That Met QC Criteria

August 21, 2017

First Posted (Actual)

August 23, 2017

Study Record Updates

Last Update Posted (Actual)

June 13, 2022

Last Update Submitted That Met QC Criteria

June 9, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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