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

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.

doi:10.1128/jcm.44.3.819-826.2006

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

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 +6 more·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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Analysis of a dataset of more than 400 patients from 6 phase III clinical trials demonstrated a strong relationship between voriconazole AUC/MIC and outcome.
“Analysis of this dataset demonstrated a strong relationship between AUC/MIC and outcome.”
From Fungal Sepsis: Optimizing Antifungal Therapy in the Critical Care Setting (2011) · cites this paper as [150]
Therapeutic success was observed in approximately 80% of patients with a voriconazole 24-hour AUC/MIC greater than 25, whereas clinical failure was noted in 45% of patients with AUC/MIC less than 25.
“Therapeutic success was observed in approximately 80% of patients with a 24-hour AUC/MIC greater than 25, whereas when the AUC/MIC was less than 25, clinical failure was noted in 45% of patients.”
From Fungal Sepsis: Optimizing Antifungal Therapy in the Critical Care Setting (2011) · cites this paper as [150]
Scatterplots of anidulafungin MICs and micafungin MICs versus caspofungin MICs show high correlation (R = 0.83), with 92% (anidulafungin) to 97% (micafungin) of all MICs within ± 2 log2 dilutions of one another.
“Indeed, scatterplots of anidulafungin MICs (Fig. 3a) and micafungin MICs (Fig. 3b) versus caspofungin MICs show high levels of correlation ( R = 0.83), with 92% (anidulafungin) to 97% (micafungin) of all MICs for the two comparisons within ± 2 log 2 dilutions of one another (230).”
From Epidemiology of Invasive Candidiasis: a Persistent Public Health Problem (2007) · cites this paper as [230]

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Physicochemical comparison of chitin and chitosan obtained from larvae and adult Colorado potato beetle (Leptinotarsa decemlineata)
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Invasive Trichosporonosis Caused byTrichosporon asahiiand Other UnusualTrichosporonSpecies at a Medical Center in Taiwan
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Current status of antifungal susceptibility testing methods
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In vivo pharmacodynamic characterization of anidulafungin in a neutropenic murine candidiasis model
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Candidemia due to Candida tropicalis: clinical, epidemiologic, and microbiologic characteristics of 188 episodes occurring in tertiary care hospitals
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Multicenter Comparison of the VITEK 2 Antifungal Susceptibility Test with the CLSI Broth Microdilution Reference Method for Testing Amphotericin B, Flucytosine, and Voriconazole against Candida spp
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Antifungal Pharmacokinetics and Pharmacodynamics
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Recent experience with fungaemia: change in species distribution and azole resistance
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Variation in Susceptibility of Bloodstream Isolates ofCandida glabratato Fluconazole According to Patient Age and Geographic Location in the United States in 2001 to 2007
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Comparative Evaluation of Etest and Sensititre YeastOne Panels against the Clinical and Laboratory Standards Institute M27-A2 Reference Broth Microdilution Method for Testing Candida Susceptibility to Seven Antifungal Agents
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Bioactive nano-metal–organic frameworks as antimicrobials against Gram-positive and Gram-negative bacteria
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Use of Pharmacokinetic-Pharmacodynamic Analyses To Optimize Therapy with the Systemic Antifungal Micafungin for Invasive Candidiasis or Candidemia
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Pharmacokinetics and Pharmacodynamics of Antifungals
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Trends in antifungal susceptibility testing using CLSI reference and commercial methods
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Antifungal Susceptibility Testing of Candida Isolates from the Candida Surveillance Study
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In VitroSusceptibilities of Yeast Species to Fluconazole and Voriconazole as Determined by the 2010 National China Hospital Invasive Fungal Surveillance Net (CHIF-NET) Study
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Activities of voriconazole, itraconazole and amphotericin B in vitro against 590 moulds from 323 patients in the voriconazole Phase III clinical studies
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A first Portuguese epidemiological survey of fungaemia in a university hospital
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Use of Fluconazole as a Surrogate Marker To Predict Susceptibility and Resistance to Voriconazole among 13,338 Clinical Isolates of Candida spp. Tested by Clinical and Laboratory Standards Institute-Recommended Broth Microdilution Methods
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Antifungal Susceptibility Testing: A Primer for Clinicians
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Treatment of invasive Candida and invasive Aspergillus infections in adult haematological patients
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Canadian Clinical Practice Guidelines for Invasive Candidiasis in Adults
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Epidemiology and Prevalence of Oral Candidiasis in HIV Patients From Chad in the Post-HAART Era
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Wild-Type MIC Distributions and Epidemiological Cutoff Values for Posaconazole and Voriconazole and Candida spp. as Determined by 24-Hour CLSI Broth Microdilution
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Infections due to Candida haemulonii: species identification, antifungal susceptibility and outcomes
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Candida endocarditis: role of new antifungal agents
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Therapeutic Drug Monitoring of Voriconazole in the Management of Invasive Fungal Infections: A Critical Review
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Rapid Susceptibility Testing and Microcolony Analysis of Candida spp. Cultured and Imaged on Porous Aluminum Oxide
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A Retrospective Analysis of Antifungal Susceptibilities of Candida Bloodstream Isolates From Singapore Hospitals
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Comparison of 24-Hour and 48-Hour Voriconazole MICs as Determined by the Clinical and Laboratory Standards Institute Broth Microdilution Method (M27-A3 Document) in Three Laboratories: Results Obtained with 2,162 Clinical Isolates of Candida spp. and Other Yeasts
Espinel‐Ingroff, A., Cantón, R., Pemán, J., Rinaldi, M. G., & Fothergill, A. W. (2009) · Journal of Clinical Microbiology · doi:10.1128/jcm.00654-09 · Cited by 49 · see citing works
Self-citation

Interpretive Breakpoints for Fluconazole and Candida Revisited: a Blueprint for the Future of Antifungal Susceptibility Testing
Pfaller, M. A., Diekema, D. J., & Sheehan, D. J. (2006) · Clinical Microbiology Reviews · doi:10.1128/cmr.19.2.435-447.2006 · Cited by 298 · see citing works
Self-citation
Clinical breakpoints for voriconazole and Candida spp. revisited: review of microbiologic, molecular, pharmacodynamic, and clinical data as they pertain to the development of species-specific interpretive criteria
Pfaller, M. A., Andes, D., Arendrup, M. C., Diekema, D. J., Espinel-Ingroff, A., Alexander, B. D., Brown, S. D., Chaturvedi, V., Fowler, C. L., Ghannoum, M. A., et al. (2011) · Diagnostic Microbiology and Infectious Disease · doi:10.1016/j.diagmicrobio.2011.03.002 · Cited by 130 · see citing works
Self-citation
Does One Voriconazole Breakpoint Suit All Candida Species?
Arendrup, M. C., & Denning, D. W. (2007) · Journal of Clinical Microbiology · doi:10.1128/jcm.00412-07 · Cited by 9 · see citing works
Development of Interpretive Breakpoints for Antifungal Susceptibility Testing: Conceptual Framework and Analysis of In Vitro-In Vivo Correlation Data for Fluconazole, Itraconazole, and Candida Infections
Rex, J. H., Pfaller, M. A., Galgiani, J. N., Bartlett, M. S., Espinel-Ingroff, A., Ghannoum, M. A., Lancaster, M., Odds, F. C., Rinaldi, M. G., Walsh, T. J., et al. (1997) · Clinical Infectious Diseases · doi:10.1093/clinids/24.2.235 · Cited by 855 · see citing works
Self-citation
1 Revised 6/5/09
-hour, C. O., Espinel‐Ingroff, A., Canton, E., Peman, J., Rinaldi, M. G., & Fothergill, A. W. (2016)
Self-citation

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 › Ecology, Evolution, Behavior and Systematics › Fungal Plant Pathogen Control
Life Sciences › Biochemistry, Genetics and Molecular Biology › Clinical Biochemistry › 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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