Study to calibrate antimicrobial susceptibility testing methods and breakpoints against EUCAST ref.standards for bedaquiline, clofazimine, levofloxacin and linezolid. 7 laboratory study with Quality Control strain ATCC 27294 (H37Rv)

Project Details

Description

Janssen is sponsoring a 7-laboratory study to calibrate antimicrobial susceptibility testing methods and breakpoints against EUCAST reference standards for bedaquiline, clofazimine, levofloxacin, and linezolid.
A requirement of the study is that all 7 laboratories receive the same lots of reagents. Another requirement is that all 7 laboratories receive the Quality Control Strain ATCC 27294 (H37Rv) and a well characterized set of clinical isolates.
ITM will perform the characterization and biobanking of the clinical isolates, the purchases of the logistic supplies, and shipping of panels of clinical isolates and supplies to all sites prior to the start of the main study.

Description

Janssen is sponsoring a 7-laboratory study to calibrate antimicrobial susceptibility testing methods and breakpoints against EUCAST reference standards for bedaquiline, clofazimine, levofloxacin, and linezolid.
A requirement of the study is that all 7 laboratories receive the same lots of reagents. Another requirement is that all 7 laboratories receive the Quality Control Strain ATCC 27294 (H37Rv) and a well characterized set of clinical isolates.
ITM will perform the characterization and biobanking of the clinical isolates, the purchases of the logistic supplies, and shipping of panels of clinical isolates and supplies to all sites prior to the start of the main study.
AcronymJ&J EUCAST
StatusFinished
Effective start/end date1/03/2130/04/24

Funding

  • Janssen Pharmaceutica N.V.: €250,719.00