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Establishing the reference broth microdilution MIC method for cefepime-taniborbactam.

Adam Belley1, Susan M Cusick1, Dan C Pevear1

  • 1Venatorx Pharmaceuticals IncMalvern, Pennsylvania, USA.

Journal of Clinical Microbiology
|August 19, 2025
PubMed
Summary

A new reference method for testing cefepime-taniborbactam, an antibiotic for resistant Gram-negative infections, was developed and validated. This reliable method ensures accurate susceptibility testing, supporting clinical decisions for difficult-to-treat bacterial infections.

Keywords:
Pseudomonas aeruginosabroth microdilutioncarbapenemasecefepimeenterobacteralesreference methodsusceptibility testingtaniborbactam

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Area of Science:

  • Microbiology
  • Clinical Laboratory Science
  • Antimicrobial Resistance

Background:

  • Serious Gram-negative bacterial infections pose a significant threat, especially those resistant to current antibiotics like third-generation cephalosporins and carbapenems.
  • The investigational β-lactam/β-lactamase inhibitor combination, cefepime-taniborbactam, shows promise for treating these challenging infections.
  • Standardized susceptibility testing methods are crucial for guiding patient care and ensuring the effective use of new antimicrobial agents.

Purpose of the Study:

  • To establish and validate a reference broth microdilution method for determining the minimum inhibitory concentration (MIC) of cefepime-taniborbactam.
  • To ensure the method conforms to Clinical Laboratory Standards Institute (CLSI) and International Standards Organization (ISO) guidelines.
  • To identify appropriate quality control (QC) parameters and strains for routine testing of cefepime-taniborbactam.

Main Methods:

  • A reference broth microdilution MIC method was developed for cefepime-taniborbactam, with taniborbactam fixed at 4 µg/mL.
  • A CLSI M23 Tier 2 study involving nine clinical microbiology laboratories was conducted.
  • The suitability of *Escherichia coli* NCTCC 13353 as a QC strain was evaluated, and various medium and assay parameters were tested for robustness.

Main Results:

  • The *Escherichia coli* NCTCC 13353 strain was confirmed as appropriate for routine QC, with established non-overlapping MIC ranges for cefepime and cefepime-taniborbactam.
  • High concordance (99.6%) was observed between obtained MIC results and the identified QC range in the interlaboratory study.
  • The method demonstrated robustness, with only significantly altered inoculum titers affecting MIC values outside the QC range.

Conclusions:

  • The developed broth microdilution MIC reference method for cefepime-taniborbactam is robust, reliable, and suitable for standardized susceptibility testing.
  • This validated method will aid in informing patient care by providing accurate MIC data for cefepime-taniborbactam.
  • The findings contribute to addressing the challenge of antibiotic-resistant infections by facilitating the clinical evaluation of cefepime-taniborbactam.