Expand New Drugs for TB [endTB]

Completed

• Conditions: Tuberculosis, Multidrug-Resistant
• Interventions: Other: This is a non-intervention observational study

• 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

Study Timeline

• Study Start: 2015-04-01
• Study First Submitted: 2017-08-21
• Study First Submitted QC: 2017-08-21
• Study First Posted: 2017-08-23
• Primary Completion: 2019-09-30
• Study Completion: 2019-12-30
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-09
• Last Update Posted: 2022-06-13

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

Arm && Interventions

Group	Intervention	Description
Delamanid and companion WHO Group 5 drugs	This is a non-intervention observational study	-
Bedaquiline and companion WHO Group 5 drugs	This is a non-intervention observational study	-

Primary Outcome Measures

Name	Time	Method
End of treatment outcome	20 - 24 months of treatment	Final outcomes: cured, treatment completed, treatment failed, lost to follow-up, died, not evaluated

Trial Locations

Locations (16)

Republican Research and Practical Centre for Pulmonology and Tuberculosis; 🇧🇾 Minsk, Belarus

National Institute of Diseases of the Chest and Hospital (NIDCH), Dhaka; 🇧🇩 Dhaka, Bangladesh

National Center for Tuberculosis and Lung Diseases; 🇬🇪 Tbilisi, Georgia

National Research Center for Phthisionpulmonology; 🇰🇿 Almaty, Kazakhstan

Botshabelo Hospital; 🇱🇸 Maseru, Lesotho

Gulab Devi Chest Hospital, Lahore; 🇵🇰 Lahore, Pakistan

National Treatment Centre for Tuberculosis, Abovian, Armenia; 🇦🇲 Abovyan, Armenia

Institute of Chest Diseases, Kotri; 🇵🇰 Kotri, Pakistan

Socios en Salud; 🇵🇪 Carabayllo, Peru

Bishoftu Hospital; 🇪🇹 Bishoftu, Ethiopia

Kara-Suu District TB hospital; 🇰🇬 Kara-Suu, Kyrgyzstan

RS Islam Jakarta Cempaka Putih; 🇮🇩 Jakarta, Indonesia

MSF Tuberculosis clinic, Mathare, Nairobi, Kenya; 🇰🇪 Nairobi, Kenya

Aung San Tuberculosis Hospital; 🇲🇲 Yangon, Myanmar

The Indus Hospital, Karachi; 🇵🇰 Karachi, Pakistan

King Dinuzulu Hospital; 🇿🇦 Durban, South Africa