Key result
A global active drug safety monitoring project demonstrated feasibility by successfully enrolling 309 patients with drug-resistant tuberculosis treated with bedaquiline and/or delamanid across 41 centers in 27 countries.
Why the study?
Comprehensive active TB drug safety surveillance is difficult to implement globally, motivating a study to assess the feasibility of national registers and describe adverse events from new anti-TB regimens.
Population
309 cases treated with bedaquiline- and/or delamanid-containing regimens across 41 centres in 27 countries
Comparison
Regimens containing bedaquiline, delamanid, or both drugs
Design
Multicentre global feasibility and prospective surveillance study
Authors
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Supports multinational safety monitoring for drug-resistant TB therapies; leaves open questions on data quality, scalability, and clinical impact.
Observational (n=309)
Yes
The study demonstrates the global feasibility of implementing active drug safety monitoring for new drug-resistant tuberculosis regimens across 27 countries.
Akkerman et al. (2019) conducted an observational in Drug-resistant tuberculosis (n=309). Bedaquiline and/or delamanid was evaluated on Feasibility of implementing national active drug safety monitoring (aDSM) registers (number of cases fully reported). A global active drug safety monitoring project demonstrated feasibility by successfully enrolling 309 patients with drug-resistant tuberculosis treated with bedaquiline and/or delamanid across 41 centers in 27 countries.
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