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1 WHAT IS NEW IN 2013: UPDATE ON EUCAST BREAKPOINTS Dr. Rafael Cantón Hospital Universitario Ramón y Cajal SERVICIO DE MICROBIOLOGÍA Y PARASITOLOGÍA Departamento de Microbiología II Universidad Complutense. Madrid

2 Contract EUCAST General Committee (GC) All European Countries + Countries from outside EUCAST Steering Committee BSAC, CA-SFM, CRG, NWGA, SRGA + 3 reps from the GC ± 2 visiting members from the GC Subcommittees Antifungals Expert Rules Anaerobes Resistance mechanisms National Breakpoint Committees F, N, NL, S, UK NACs = National Antimicrobial Susceptibility Testing Committees Experts (ECDC Networks, ESCMID Study Groups) Industry

3 Q1 EUCAST implementation

4 EUCAST General Committee - 35 countries, including Russia and Australia - New countries with interest of being represented (Brazil, US, Japan ) National breakpoint committees and NACs - Continuous consultation on breakpoints - New countries already represented in the General Committee formed a NAC (Portugal, Germany, ) - New countries outside Europe have declared interest to form a NAC (Brazil, US,..) Four new Standard Operation Procedures ( ) Review and revision of breakpoints EUCAST committees EUCAST interaction with NACs maintenance of EUCAST web site (on going)

5 Yes National AST Committees (NACs), January 2013 In the process of forming a NAC No No information Ireland Great Britain Netherlands Belgium Luxembourg Norway Denmark Germany Sweden Czech Republic Poland Finland Estonia Latvia Lithuania Slovakia Greece Belarus Moldova France Switzer- Austria Hungary land Romania Slovenia Croatia Serbia Bosnia- Herze- Monte- Bulgaria govina Portugal Italy negro Macedonia Spain Albania Ukraine Turkey Russia Malta Countries not on the map: Australia Iceland Israel

6 Implementation of EUCAST breakpoints, January 2013 % Laboratories >50% 10-50% <10% No information Ireland Great Britain France Netherlands Belgium Luxembourg Norway Denmark Germany Switzerland Sweden Czech Republic Austria Slovenia Poland Hungary Finland Estonia Latvia Lithuania Slovakia Greece Belarus Romania Moldova Croatia Serbia Bosnia- Herze- Monte- Bulgaria govina Portugal Italy negro Macedonia Spain Albania Ukraine Turkey Russia Malta Countries not on the map: Australia Iceland Israel

7 Country Guidelines followed in EARS-Net EQA 2012 (National representation is biased, as in UK NEQAS) EARS-Net Guidelines used by participants Year % AT BE BU CY CZ DE DK EE ES FI FR GR HR HU IE IS IT LT LU LV MT NL NO PL PT RO SE SI TR UK No. of participants SRGA SFM NWGA CLSI EUCAST DIN BSAC ECDC/EARS-Net and UKNEQAS (C. Walton)

8 Q2 EUCAST implementation

9 EUCAST breakpoints, 2013

10 New version of EUCAST breakpoint tables v3.0 (Jan, 2013) New drugs New microorganisms Rewording of notes New footnotes for New technical notes New expressions of antimicrobials - Ceftaroline breakpoints - Pasteurella multocida, Campylobacter - S. pneumoniae and penicillins - HLGR in Enterococcus spp. - Yersinia enterocolitica - specific reading instructions for correct interpretation of the disk diffusion tests - S. maltophila and SXT - Staphylococci and benzypenicillin - Enterococci and vancomycin - fosfomycin-trometamol, now fosfomycin oral - cefuroxime, now cefuroxime i.v. - cefuroxime axetil, now cefuroxime oral New table of PK/PD (non-species related) breakpoints

11 EUCAST breakpoints, 2013 All new modifications highlighted in yellow

12 New version of EUCAST breakpoint tables v3.0 (Jan, 2013) New drugs: Ceftaroline breakpoints

13 New version of EUCAST breakpoint tables v3.0 (Jan, 2013) New drugs: Ceftaroline QC ranges On going Rationale Document

14 New version of EUCAST breakpoint tables v3.0 (Jan, 2013) New microorganisms - Pasteurella multocida Clinical brakpoints based on ECOFFs in the absence of MIC-clinical correlations Disk diffusion breakpoints calibrated with MIC breakpoints MH-F CO2, 35ºC, 18h

15 New version of EUCAST breakpoint tables v3.0 (Jan, 2013)

16 New version of EUCAST breakpoint tables v3.0 (Jan, 2013) PK/PD breakpoints listed separately

17 New version of EUCAST breakpoint tables v3.0 (Jan, 2013) PK/PD breakpoints Based on pharmacokinetic and pharmacodynamic data only Used as the basis for determination of clinical breakpoints In determination of clinical breakpoints the PK/PD breakpoint may be modified in the light of microbiological or clinical data. They may be used with microorganisms for which there are no breakpoints These breakpoints should not be used when there are species specific breakpoints, such as values, Note or in the tables

18 The EUCAST breakpoints philosophy MIC (mg/l) brpts* Zone (mm) brpts* Insufficient evidence (Literature: not enough evidence for a breakpoint or no indication ) Inappropriate drug (Literature: poor drug don t use! S 2 R>2 mg/l S 22 R<22 mm IE Can not be substituted. Can be supplemented with an MIC without interpretation. Can be substituted with an automatic R *when numbers are the same = no intermediate category

19 The EUCAST breakpoints philosophy ECOFF S R CLSI, 2010 S R EUCAST, 2010

20 The EUCAST breakpoints philosophy MIC by broth microdilution is the current reference method (ISO) If MIC testing is used, it should either be the standard reference method as described in the ISO document or am MIC method shown to give equivalent result to the ISO method If disk diffusion is used and validated following ISO guidelines, the categorization of S / I / R is fully equivalent to that of MIC testing. If there is a deviation in a local method (medium, incubation time, volume, inoculum, ) that local method should also be validated against the ISO doc. The same is true for commercial systems. Many labs state they use MICs but do deviate from the ISO protocol which may explain differences in the results

21 The EUCAST breakpoints philosophy Disk diffusion calibrated with MIC values EUCAST Laboratory for Antimicrobial Susceptibility Testing

22 EUCAST breakpoints: What is coming ? Ongoing breakpoints - New agents with EMA: - anti-mrsa cephalosporins - macrolides - anti-mycobacterials - glycopeptides - Colistin (in conjunction with CLSI and under TATFAR initiative) - Topical agents (if available based on systemic breakpoints, otherwise based on ECOFFs) - Fluoroquinolones and enterococci in UTI - Corynebacterium spp. - Co-amoxiclav and Enterobacteriaceae in UTI - Acinetobacter spp. and sulbactam - Other organisms Legionella spp., Pseudomonas non-aeruginosa spp. Actinomyces, Nocardia, Streptomyces, HACEK Aeromonas, Vibrio, Leuconostoc, Lactobacillus, Pediococcus

23 Transatlantic Taskforce on Antimicrobial Resistance Antimicrobial resistance is a significant and multifaceted public health problem Purpose of the taskforce To identify urgent antimicrobial resistance issues that could be better addressed by intensified cooperation between the US and the EU within the following key areas: 1. Appropriate therapeutic use of antimicrobials in the medical and veterinary communities 2. Prevention of healthcare- and communityassociated drug-resistant infections 3. Strategies for improving the pipeline of new antimicrobial drugs

24 Colistin / polymixin B breakpoints Initiative to set common EUCAST and CLSI breakpoints Memorandum of Understanding (MOU) - signed Oct-12, 2012 and effective Nov-1, 2012 Nov 1, 2013 Creation of ad hoc Working Group - 2 co-chairs, 2+2 members representing EUCAST and CLSI - absence of members with commercial / industry affiliation - colistin and polymixin B breakpoints for - Enterobacteriaceae - Pseudomonas aeruginosa - Acinetobacter spp.

25 EUCAST breakpoints: What is coming ? General consultation until 14 June 2013 Breakpoints are based on epidemiological cut-off values (ECOFFs)

26 EUCAST breakpoints: What is in coming ?

27 Contract EUCAST General Committee All European Countries + Countries from outside EUCAST Steering Committee BSAC, CA-SFM, CRG, NWGA, SRGA And 3 reps from the General Committee Subcommittees Antifungals Expert Rules Anaerobes Resistance mechanisms National Breakpoint Committees F, N, NL, S, UK NACs = National AntibiogramCommittees Experts (ECDC Networks, ESCMID Study Groups)

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29 EUCAST website changes

30 all free, no charge!

31 Acknowledgements EUCAST Laboratory for Antimicrobial Susceptibility Testing and participant laboratories