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June 15, 2022 | Johnson & Johnson – Bedaquiline Drug Resistance Assessment in MDR-TB (DREAM)

Bedaquiline Drug Resistance Assessment in MDR-TB (DREAM)
Conducted by Johnson & Johnson Family of Companies

Countries: India, Lithuania, Pakistan, Philippines, South Africa, South Korea, Taiwan, Thailand, Turkey, USA, Viet Nam

Primary objective
To determine the level of susceptibility of MDR-TB isolates to BDQ by the minimal inhibitory concentration (MIC) drug susceptibility testing (DST) methods.

 

Protocol SummaryDREAM program to determine the level of susceptibility of multidrug-resistant tuberculosis isolates to bedaquiline. Preliminary identification and rapid DST are performed at the local labs. Pure cultures are sent to the NTRL for additional phenotypic DST.
Isolates must be or must have been collected from MDR-TB patients. In some cases, resistance to rifampicin is sufficient. Non-mycobacteria, non-tuberculosis mycobacteria and rifampicin susceptible MTB are excluded.
Currently there are no FDA/CLSI breakpoints for BDQ. EUCAST had established a provisional susceptible breakpoint of ≤0.25 mg/L irrespective of the test medium. Given that the EUCAST breakpoint was based on limited data available at the time, we are defining new interpretive criteria based on ECV/ECOFF from the data generated. These in turn are used to interpret the surveillance results.
Isolates collection method:A mix of prospective and retrospective isolates are collected locally and submitted to the National TB Reference Laboratory (NTRL).
Types of surveillance:Isolates are collected primarily for routine clinical practice, then used for surveillance.
Number of Isolates5,036
Contains pediatric data?N/A
Contains genotype data?No
Date Last Updated31-July-2019 (last isolate collected)
Expected frequency of updates to the datasetNone
List of publications to be linked J Clin Microbiol 60:e02919-20. doi.org/10.1128/JCM.02919-20
Supporting documents to be provided
Any additional information