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Setting and revising antibacterial susceptibility breakpoints.

John Turnidge1, David L Paterson

  • 1Division of Laboratory Medicine, Women's and Children's Hospital, 72 King William Rd., North Adelaide, South Australia, Australia. john.turnidge@cywhs.sa.gov.au

Clinical Microbiology Reviews
|July 17, 2007
PubMed
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Setting clinical breakpoints for antibacterial susceptibility testing requires integrating MIC data, pharmacokinetics/pharmacodynamics, and clinical outcomes. Regular review is essential, especially with emerging resistance mechanisms.

Area of Science:

  • Clinical Microbiology
  • Pharmacology
  • Infectious Diseases

Background:

  • Clinical microbiology laboratories report antibacterial susceptibility testing results to guide treatment.
  • Interpreting these results, beyond Minimum Inhibitory Concentrations (MICs), is crucial for most prescribers.
  • Clinical breakpoints are essential for determining the potential utility of antibacterials against bacterial infections.

Purpose of the Study:

  • To outline the essential components and considerations for setting and revising clinical breakpoints for antibacterial agents.
  • To emphasize the importance of integrating diverse data for accurate breakpoint determination.

Main Methods:

  • Breakpoint setting involves analyzing wild-type MIC distributions, pharmacokinetic/pharmacodynamic (PK/PD) properties, and clinical outcomes.

Related Experiment Videos

  • Revising breakpoints necessitates evaluating new data, particularly when resistance mechanisms emerge after a drug's clinical introduction.
  • Utilizing well-designed observational studies is critical for gathering reliable data for breakpoint reevaluation, especially post-commercial release.

    • Main Results:

    • Clinical breakpoints should be established before an antibacterial is used clinically.
    • Ongoing review of breakpoints is mandatory, particularly with documented resistance.
    • Phenotypic resistance detection tests can complement breakpoint interpretation.

    Conclusions:

    • Accurate clinical breakpoints are vital for effective antibacterial therapy.
    • A multidisciplinary approach integrating PK/PD, MIC data, and clinical outcomes is necessary for breakpoint setting and revision.
    • Continued research and surveillance are essential to maintain the clinical relevance of breakpoints.