Multicenter Clinical Evaluation of ETEST Eravacycline for Susceptibility Testing of Enterobacteriaceae and Enterococci

Abstract

Eravacycline (ERV) (brand name Xerava [Tetraphase]) is a new tetracycline-class antibacterial that has been approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for treatment of complicated intra-abdominal infections (cIAIs). ETEST is a gradient diffusion method that represents a simple alternative to the broth microdilution (BMD) method for performing antimicrobial susceptibility testing (AST). A multicenter evaluation of the performance of the new ETEST ERV (bioMérieux) in comparison with BMD was conducted following FDA and International Standards Organization (ISO) recommendations, using FDA- and EUCAST-defined breakpoints. Clinical isolates of Enterobacteriaceae (n = 542) and Enterococcus spp. (n = 137) were included. Based on the BMD reference method, 92 Enterobacteriaceae isolates and 9 enterococcal isolates were nonsusceptible to ERV according to the FDA breakpoints, while 7 Escherichia coli isolates and 3 Enterococcus sp. isolates were classified as ERV resistant according the EUCAST breakpoints. Referring to FDA performance criteria, the ETEST ERV demonstrated 99.4% and 100.0% essential agreement (EA), 98.0% and 94.9% categorical agreement (CA), very major error (VME) rates of 5.4% and 33.33%, and major error (ME) rates of 1.3% and 3.1% with clinical and challenge isolates, respectively, of Enterobacteriaceae and Enterococcus spp. According to EUCAST breakpoints, E. coli and Enterococcus sp. isolate results also met ISO acceptance criteria for EA and CA (EA of 99.0% and 100.0%, respectively, and CA of 100.0% for both), without any VMEs or MEs. In conclusion, we report that ETEST ERV represents an accurate tool for performing ERV AST of Enterobacteriaceae and Enterococcus sp. isolates.