endTB Observational Study

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

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endTB Observational Study

At a time when programs were struggling to design effective regimens for the treatment of multidrug-resistant tuberculosis (MDR-TB), the marketing authorization of bedaquiline and delamanid was a critical development in the MDR-TB treatment landscape. However, despite their availability for routine programmatic use, the uptake of these drugs has remained slow; concerns included a lack of evidence on safety and efficacy and the need to protect the new drugs from the development of acquired resistance. As part of the endTB Project, we aimed to address these barriers by generating evidence on safety and efficacy of bedaquiline or delamanid based MDR-TB regimens.

endTB fatal and life-threatening SAE report

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endTB Observational Study

Report of fatal and life-threatening adverse events during endTB post-marketing safety surveillance of new and repurposed TB drugs

As part of the endTB project and observational study (2015-2019), rigorous post-marketing safety surveillance for all patients (referred to as "endTB patients") who began MDR/RR-TB regimens containing bedaquiline or delamanid was performed. This safety surveillance conformed to the "advanced" active TB Drug Safety Monitoring and Management (aDSM) package as defined by WHO (WHO/HTM/TB/2015.28).

endTB Study Group Members

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endTB Observational Study

The endTB Study Group is the group that is responsible for the endTB Observational Study (NCT02754765), which includes more than 2700 patients started on bedaquiline and delamanid containing regimens in 17 countries. Organized by country, this is a list of doctors, nurses, data managers, pharmacists, social workers, administrators and others who have spent many hours collecting and cleaning data, working closely with patients, and ensuring that the endTB Observational Study works smoothly in every aspect of its complex existence.

Technical Basis of the endTB Observational Study (EN/RU/ES/FR)

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endTB Observational Study

endTB Observational Study had sites in 17 countries. In each country, sites enrolled patients on treatment with bedaquiline and delamanid according to National TB Program guidelines, while collecting clinical and bacteriological data on efficacy and safety. Because many of the endTB Observational Study tools were found to be useful for clinicians and programs that were starting to use the new TB drugs and regimens, we made them freely available at the endTB website.

endTB Interim Analysis Report (EN / ES / RUS)

Front cover, endTB Interim Analysis Report

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endTB Observational Study

Bedaquiline- and delamanid- containing regimens achieve excellent interim treatment response without safety concerns: This report presents the results of three different analyses (a safety analysis, a delamanid analysis, and an injectables analysis) to improve the evidence base for using bedaquiline and delamanid in drug-resistant TB regimens. Available in English, Spanish, and Russian.