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Expand New Drugs for TB [endTB] | Clinical Trials | Clareo Health

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Expand New Drugs for TB [endTB]

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

NCT03259269•Partners in Health

View on ClinicalTrials.gov

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.

Eligibility

Age

All ages

Sex

ALL

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.

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

Aung San Tuberculosis Hospital

Yangon, Burma

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

Key Dates

Start Date

April 1, 2015

Primary Completion Date

September 30, 2019

Completion Date

December 30, 2019

Last Updated

June 13, 2022

Enrollment

2,804

ACTUAL participants

Conditions

Tuberculosis, Multidrug-Resistant

Interventions

This is a non-intervention observational study

OTHER

Pharmacokinetic Study to Evaluate Anti-mycobacterial Activity of TMC207 in Combination With Background Regimen (BR) of Multidrug Resistant Tuberculosis (MDR-TB) Medications for Treatment of Children/Adolescents With Pulmonary MDR-TB

NCT02354014

Tuberculosis, Multidrug-Resistant

View study

RECRUITINGPHASE2

Efficacy and Tolerability of Bedaquiline, Delamanid, Levofloxacin, Linezolid, and Clofazimine to Treat MDR-TB

NCT03828201

Tuberculosis, Multidrug-Resistant

View study

NOT_YET_RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 13, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Expand New Drugs for TB [endTB]

Inclusion Criteria

Exclusion Criteria

Pharmacokinetic Study to Evaluate Anti-mycobacterial Activity of TMC207 in Combination With Background Regimen (BR) of Multidrug Resistant Tuberculosis (MDR-TB) Medications for Treatment of Children/Adolescents With Pulmonary MDR-TB

Efficacy and Tolerability of Bedaquiline, Delamanid, Levofloxacin, Linezolid, and Clofazimine to Treat MDR-TB

Registry on the Effectiveness and Safety of the 9-month MDR-END Treatment Regimen in Korean Patients with FQ-sensitive MDR-TB (MDR-END Registry)

Various Doses and Durations of Linezolid Plus Bedaquiline & Pretomanid in Participants With Drug Resistant Tuberculosis

Preventing Acquired Resistance: Strengthen TB Treatment by Adding Amikacin in the First Treatment Week of Multidrug-resistant Tuberculosis

DIAgnostics for Multidrug Resistant Tuberculosis in Africa