Cited by 258Antifungal resistance and susceptibilityFungal Plant Pathogen ControlBacterial Identification and Susceptibility Testing

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Correlation of MIC with Outcome for Candida Species Tested against Voriconazole: Analysis and Proposal for Interpretive Breakpoints

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Pfaller, M. A., Diekema, D. J., Rex, J. H., Espinel-Ingroff, A., Johnson, E. M., Andes, D., Chaturvedi, V., Ghannoum, M. A, Odds, F. C., Rinaldi, M. G., Sheehan, D. J., Troke, P., Walsh, T. J., Warnock, D. W.·2006·Journal of Clinical Microbiology

DOI 10.1128/jcm.44.3.819-826.2006PMC PMC1393146

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Abstract

Developing interpretive breakpoints for any given organism-drug combination requires integration of the MIC distribution, pharmacokinetic and pharmacodynamic parameters, and the relationship between the in vitro activity and outcome from both in vivo and clinical studies. Using data generated by standardized broth microdilution and disk diffusion test methods, the Antifungal Susceptibility Subcommittee of the Clinical and Laboratory Standards Institute has now proposed interpretive breakpoints for voriconazole and Candida species. The MIC distribution for voriconazole was determined using a collection of 8,702 clinical isolates. The overall MIC 90 was 0.25 μg/ml and 99% of the isolates were inhibited at ≤1 μg/ml of voriconazole. Similar results were obtained for 1,681 Candida isolates (16 species) from the phase III clinical trials. Analysis of the available data for 249 patients from six phase III voriconazole clinical trials demonstrated a statistically significant correlation ( P = 0.021) between MIC and investigator end-of-treatment assessment of outcome. Consistent with parallel pharmacodynamic analyses, these data support the following MIC breakpoints for voriconazole and Candida species: susceptible (S), ≤1 μg/ml; susceptible dose dependent (SDD), 2 μg/ml; and resistant (R), ≥4 μg/ml. The corresponding disk test breakpoints are as follows: S, ≥17 mm; SDD, 14 to 16 mm; and R, ≤13 mm.

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Authors: Pfaller, M. A., Diekema, D. J., Rex, J. H., Espinel-Ingroff, A., Johnson, E. M., Andes, D., Chaturvedi, V., Ghannoum, M. A., Odds, F. C., Rinaldi, M. G., Sheehan, D. J., Troke, P., Walsh, T. J., & Warnock, D. W.
Affiliations: University of Iowa (US)
AstraZeneca (United Kingdom) (GB)
VCU Medical Center, Richmond, Virginia
HPA Centre for Infections, Kingsdown, Bristol, United Kingdom
University of Wisconsin–Madison (US)
New York State Department of Health (US)
Case Western Reserve University (US)
University of Aberdeen (GB)
The University of Texas at San Antonio Health Science Center (US)
Pfizer (United States) (US)
Pfizer (United Kingdom) (GB)
National Institutes of Health (US)
Centers for Disease Control and Prevention (US)
Corresponding author: Pfaller, M. A.
ORCID: Pfaller, M. A.
Diekema, D. J.
Rex, J. H.
Johnson, E. M.
Andes, D.
Chaturvedi, V.
Ghannoum, M. A
Walsh, T. J.
Venue: Journal of Clinical Microbiology
Publisher: American Society for Microbiology
Published: 2006-03
Volume: 44
Issue: 3
Pages: 819-826
ISSN: 0095-1137 (ISSN-L)
1098-660X
DOI: 10.1128/jcm.44.3.819-826.2006
PMC: PMC1393146
OpenAlex: W2138433856
Cited by: 258
References: 43
Citations by year: 2026: 4 · 2025: 3 · 2024: 4 · 2022: 4 · 2021: 2 · 2020: 2 · 2019: 4 · 2018: 4 · 2017: 3 · 2016: 3 · 2015: 12 · 2014: 8 · 2013: 5 · 2012: 16
FWCI: 25.48
Type: journal article
Language: en
Open access: green
www.ncbi.nlm.nih.gov
Licence: journals.asm.org/non-commercial-tdm-license (tdm)
Locations: Journal of Clinical Microbiology (publishedVersion)
Europe PMC (PubMed Central) (publishedVersion)
PubMed Central (publishedVersion)
PubMed (publishedVersion)
Funders: Pfizer
Topics: Health Sciences › Medicine › Infectious Diseases › Antifungal resistance and susceptibility
Life Sciences › Agricultural and Biological Sciences › Plant Science › Fungal Plant Pathogen Control
Health Sciences › Medicine › Microbiology (medical) › Bacterial Identification and Susceptibility Testing
Keywords: voriconazole, Candida species, interpretive breakpoints, minimum inhibitory concentration, antifungal susceptibility, MIC distribution, antifungal resistance
MeSH terms: Antifungal Agents, Candida, Candidiasis, Data Interpretation, Statistical, Humans, Microbial Sensitivity Tests, Pyrimidines, Triazoles, Fluconazole, Inhibitory Concentration 50, Endpoint Determination, Drug Resistance, Fungal, Voriconazole

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Correlation of MIC with Outcome for Candida Species Tested against Voriconazole: Analysis and Proposal for Interpretive Breakpoints

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