Expand New Drugs for TB [endTB]

Conditions

Tuberculosis, Multidrug-Resistant

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.

Kho S, Seung KJ, Huerga H, Bastard M, Khan PY, Mitnick CD, Rich ML, Islam S, Zhizhilashvili D, Yeghiazaryan L, Nikolenko EN, Zarli K, Adnan S, Salahuddin N, Ahmed S, Vargas ZHR, Bekele A, Shaimerdenova A, Tamirat M, Gelin A, Vilbrun SC, Hewison C, Khan U, Franke M.

2024-05-094 citations

10.1038/s41467-024-48077-8

Safety of Treatment Regimens Containing Bedaquiline and Delamanid in the endTB Cohort

Catherine Hewison, Uzma Khan, Mathieu Bastard, Nathalie Lachenal, Sylvine Coutisson et al. (32 authors)

Clinical Infectious Diseases2022-01-1250 citations

10.1093/cid/ciac019

Culture Conversion at 6 Months in Patients Receiving Delamanid-containing Regimens for the Treatment of Multidrug-resistant Tuberculosis

Kwonjune J. Seung, Palwasha Khan, Molly F. Franke, Saman Ahmed, Stalbek Aiylchiev et al. (26 authors)

Clinical Infectious Diseases2019-10-3019 citations

10.1093/cid/ciz1084

The endTB observational study protocol: treatment of MDR-TB with bedaquiline or delamanid containing regimens

Uzma Khan, Helena Huerga, Aamir J. Khan, Carole D. Mitnick, Catherine Hewison et al. (12 authors)

BMC Infectious Diseases2019-08-2046 citations

10.1186/s12879-019-4378-4

Interventions

OTHERThis is a non-intervention observational study

No applicable intervention; this is a secondary data analysis observational study.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

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.

Design outcomes

Primary

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

Countries

Armenia, Bangladesh, Belarus, Burma, Ethiopia, Georgia, Indonesia, Kazakhstan, Kenya, Kyrgyzstan, Lesotho, Pakistan, Peru, South Africa

Outcome results

None listed