Implementing best practises on data generation and reporting of Mycobacterium tuberculosis time kill assays: a case study of standardized protocol within the ERA4TB consortium
Tuberculosis (TB) is the deadliest infectious disease after COVID-19. The European Regimen Accelerator for Tuberculosis (ERA4TB) is a public-private partnership of more than 30 different institutions with the objective to progress new anti-TB regimens into the clinic. Thus, robust and replicable results across independent laboratories are essential for reliable interpretation of treatment efficacy. Time-kill assays provide essential input data for pharmacometric model informed translation of single agents and regimens activity from in vitro to in vivo and clinic.
An ERA4TB standardization workgroup was established to unify time-kill assay protocols and data reporting templates. Five conditions were assessed in six independent laboratories using four bacterial plating methods. Baseline bacterial burden varied between laboratories, but variability in net drug effect was limited.
This exercise lays down the foundations of collaborative efforts for robust data generation, reporting and integration within the overarching Antimicrobial Resistance Accelerator programme.
This work has received support from the Innovative Medicines Initiatives 2 Joint Undertaking (grant No 853989).