EUCASTEUCASTChairman´s report to the ESCMID Chairman´s report to the ESCMID

February 28, 2003February 28, 2003

Gunnar Kahlmeter Chairman 2002 – 2004

EUCASTEUCAST

ESCMID boardESCMID board

EUCAST general committeEUCAST general committe

EUCAST steering committeEUCAST steering committe

EUCAST general committee 2003EUCAST general committee 2003Austria Prof Helmut MittermayerBelgium Prof Jan VerhaegenBosnia Dr Selma Uzunovic-KamberovicBulgaria Prof Krassimir MetodievCroatia Dr Arjana Tambic-AndrasevicCzech Republic Dr Pavla UrbaskovaDenmark Dr Niels Frimodt-MøllerEstonia Dr Paul NaaberFinland Dr Antti NissinenFrance Dr Fred W. GoldsteinGermany Prof Bernd WiedemannGreece Prof Alkiviadis VatopoulosHungary Dr Éva BánIceland Dr Karl Gustaf KristinssonIreland Dr Martin CormicanItaly Prof Enrico MaglianoLithuania Prof Arvydsa AmbrozaitisNetherlands Prof John DegenerNorway Dr Martin SteinbakkPoland Prof Waleria HryniewiczPortugal Prof Jose Melo CristinoRomania no official representativeRussia Prof Sergei Sidorenko

Serbia Dr Lazar RaninSlovak Republic Prof. Milan NiksSlovenia Dr Jana KolmanSpain Dr Francisco SorianoSweden Dr Barbro Olsson-LiljequistSwitzerland Prof Jaques BilleTurkey Dr Deniz GürUK Prof Richard WiseYugoslavia representative not confirmed

Pharmaceutical Industry RepresentativesProf. André Bryskier, Hoechst Marion RousselRep 2 not nominated

Device Manufacturers RepresentativesDr. Jean-Pierre Marcel, bioMérieux (appointed by STMA*)Ms. Maureen Mansfield, TREK (appointed by STMA*)Mr. Daniel Malait, Bio-Rad (appointed by STMA*)Mr. Ivo Steenackers, Becton-Dickison (appointed by STMA*)

*Susceptibility Testing Manufacturers Association

EUCAST steering committeeEUCAST steering committee2002 - 2004 2002 - 2004

• Gunnar Kahlmeter, chairman 2004• Derek Brown, Scientific secretary 2004

• Alasdair MacGowan, BSAC (The UK)2004• Fred Goldstein, CA-SFM (France) 2004• Johan W. Mouton, CRG (Netherlands) 2004• Arne Rodloff, DIN (Germany) 2004• Martin Steinbakk, NWGA (Norway) 2004• Anders Österlund, SRGA (Sweden) 2004• Pavla Urbaskova (Czech Republic), EUCAST rep 1 2003• Alkiviadis Vatopoulos (Greece), EUCAST rep 2 2003

EUCAST steering committee 28th of January, 2003EUCAST steering committee 28th of January, 2003

EUCAST appointmentsEUCAST appointments

ESCMID appointsESCMID appoints• chairman and scientific secretary every 3 years• National breakpoint committee seats on the steering committee every

3 years• 2 representatives from the EUCAST general committe from countries

not represented on the steering committee through national breakpoint committee.

European countries European countries • appoint one representative each to serve for 2 years (new or

confirmed appointments 2004)• can apply to the ESCMID board to be considered for a seat on the

steering committee. To be eligible the country needs to have an active breakpoint committee or AST methodology committee with regular meetings (at least 4 per year are desirable for the BP-process).

EUCAST websites

• www.eucast.org – directly links to the EUCAST web-page on ESCMID site

• ”www.eucast-steeringcommittee” – is used only by the steering committee (login with password needed)

• ”www.wild-type-distributions” – new software – login for contributors of data; no login needed for access to data.

Chairman´s activities since appointmentChairman´s activities since appointmentActivities in bold - paid by ESCMID

• September 2, 2001• September 11, 2001 • October 3, 2001 • October 4, 2001• November 2001• November 2001• December 2001• December 2001• January 2002• February 2002• April 2002• April 2002• 2001/2002• May 2002• June 2003• July 2002• September 2002• October 2002• November 2002• November 2002• December 2002• 8-15 January 2003 • 28 January 2003• 27 February 2003

SRGA in Stockholm CRG in Bilthoven CA-SFM in ParisOEI (Orgainzation Epizotic International) in ParisEARSS meeting in ViennaRIVM and EARSS, AmsterdamBSAC in BirminghamESCMID board meeting in VeniceNEQAS in LondonNWGA in OsloESCMID board meeting in ItalyECCMID - EUCAST workshop/meeting Milan EARSS advisory board meetings in Bilthoven ECC in ParisIACMAC meeting in MoscowEARSS report 2001 - Amsterdam ICAAC in San DiegoEUCAST reference database programmeEARSS meeting in BathSteering committee meeting in ShipholLeading article on QA in JAC (DB and GK) NCCLS, Tampa, USASteering committee meeting, FrankfurtESCMID board meeting in Amsterdam

EUCAST presented at/toEUCAST presented at/to

• European Medicine´s Evaluation Agency (2002)• EARSS (2001, 2002)

• NEQAS (2002)• Organisation Internationale Epizotic (2001)

• NCCLS – bacteriology committe, antifungal committee, vet.committee (2003)

• At international meetings: ECCMID (Milan 2002), ICAAC (San Diego 2002), FESCI (Paris 2002), IACMAC (2002),

Drug Information Agency (2003)

• At national meetings in Sweden, Denmark, The UK, Norway (2002), ….

EUCAST invitations to co-operationEUCAST invitations to co-operation

• Medicine´s agencies (EMEA)• Breakpoint committees (NCCLS)

• International Veterinary organisations• Drug industry (EFPIA)

• Technical industry (STMA)• Surveillance (EARSS, NARMS etc)

• Scientific organisations (ISC, FESCI)• EQA-programmes (EARSS, NEQAS)

EMEA – discussions in London, dec 2003EMEA – discussions in London, dec 2003Derek Brown, Alasdair MacGowan, G Kahlmeter (phone)

EMEA will recognize EUCAST as the umbrella organisation for European national organisations provided:- affirmation from national committees is obtained- a non-industrial involvement on the financial side can be guaranteed- affirmation from other interested parties, such as DG-SANCO, ISC/FESCI, FEMS, EFPIA, can be obtained - in progress!

EUCAST is represented onEUCAST is represented on

• The national breakpoint committees

• EARSS

• NCCLS

The EUCAST steering committee has defined…

Clinical breakpointsClinical breakpoints

S< X and R> Y mg/L

New definitions of clinical breakpoints (S, I & R).

Epidemiological cut-off valuesEpidemiological cut-off values

WT < Z mg/L

Definitions of wild type and epidemiological cut-off values (WT and NWT).

• Closed all subcommittees except the subcommittee on Closed all subcommittees except the subcommittee on antifungal susceptibility testing (EUCAST AFST)antifungal susceptibility testing (EUCAST AFST)

• Decided on a common expression for SDecided on a common expression for S<< and R> and R>

•Decided on a common MIC microbroth dilution methodDecided on a common MIC microbroth dilution methodas reference gold standard.as reference gold standard.

• Decided on a process for setting breakpoints for new Decided on a process for setting breakpoints for new antibiotics (try outs: daptomycin, garenoxacin – both antibiotics (try outs: daptomycin, garenoxacin – both

companies contacted)companies contacted)

• Decided on a process for harmonising breakpoints for Decided on a process for harmonising breakpoints for existing antibiotics (existing antibiotics (fluoroquinolones fluoroquinolones successfully successfully

done, done, aminoglycosidesaminoglycosides, , glycopeptidesglycopeptides and and linezolidlinezolid is is on)on)

• Proposed definitions for wild type bacteria and Proposed definitions for wild type bacteria and epidemiological cut-off valuesepidemiological cut-off values

The EUCAST steering committee has…

EUCAST at ECCMID in GlasgowEUCAST at ECCMID in Glasgow

Harmonization of quinolone breakpoints in Europe (12/5, 10-12)Chairpersons: Dr Martin Steinbakk (Norway) Dr Fred Goldstein (France)1. Current breakpoints and the EUCAST approach to harmonization of breakpoints -

Dr Derek Brown (UK) (10 min)2. EMEA view on the harmonization of European breakpoints

Dr Bo Aronsson (London, UK) (15 min)3. Epidemiological cut off values based on wild type MIC distributions -

Dr Gunnar Kahlmeter (Sweden) (15 min)4. Pharmacodynamic approach and Monte Carlo simulation in establishing breakpoints

Dr Johan W. Mouton (Netherlands) (15 min)6. Tentative harmonized breakpoints for quinolones

Dr Gunnar Kahlmeter (Växjö, Sweden) (10 min)7. General discussion (30 min)

Business meeting 12.15 - 13.30

Poster for the ESCMID poster corner

EUCAST software: EUCAST software: ””Antimicrobial wild type distributions”Antimicrobial wild type distributions”with EUCAST clinical breakpoints and with EUCAST clinical breakpoints and

epidemiological cut-off valuesepidemiological cut-off values

The prototype is ready and paid for by ESCMID:6000 euro + VAT

The bad news is – I need more for the final The bad news is – I need more for the final development: 3000 euro + VAT development: 3000 euro + VAT

Approximately 750 distributions have been entered.

Aggregated Ciprofloxacin/E.coli MIC-distributions from 6 separate data sources(national breakpoint committees, Antimicrobial resistance surveillance programs, EARSS, drugcompany data etc)

EUCAST – expenditure 2002EUCAST – expenditure 2002

• Chairman´s expenses 2002 : - NEQAS meeting in London, January 2002- ESCMID board meeting and ECCMID, Milan, Italy, April 2002- EUCAST reference database programme, autumn 2002

• EUCAST steering committee meetings- Shiphol, November 2002, 10 people

EUCAST – expected expenditure 2003EUCAST – expected expenditure 2003

• 4 scheduled steering committe meetings (10 – 15 000 Euro (?) per meeting):- January, Frankfurt- May, ECCMID, Glasgow- September- November

• Soft ware: Wild type MIC- and Zone distributions – 3000 euro• Chairman´s travels – NCCLS, EMEA, ESCMID board: 5 – 10 000

Euro.

• Newsletter has been dropped - contributions to go to the ESCMID Newsletter instead.

• EU funding (application to go in March, 2003)• ESCMID industry contributions (?)

Clinically Susceptible a micro-organism is defined as susceptible by a level of antimicrobial activity

associated with a likelihood of therapeutic success A micro-organism is categorized as susceptible (S) by applying the appropriate

breakpoint in a defined phenotypic test system This breakpoint may be altered with legitimate changes in circumstances

Clinically intermediate a micro-organism is defined as intermediate by a level of antimicrobial

activity associated with indeterminate therapeutic effect

Clinically resistant a micro-organism is defined as resistant by a level of antimicrobial

activity associated with a higher than expected likelihood oftherapeutic failure.

a micro-organism is categorized as resistant (R) by applying theappropriate breakpoint in a defined phenotypic test system

This breakpoint may be altered with legitimate changes incircumstances

Tentative new EUCAST definitions of S, I and R Tentative new EUCAST definitions of S, I and R

Clinical breakpoints are given as S<X mg/L, R>Y mg/L

Microbiological resistance and epidemiologicalcut-off values

Wild type (WT<X mg/L)

a micro-organism is defined as belonging to the wild type (WT) for a speciesby the absence of acquired resistance mechanisms to the drug in question.

a micro-organism is categorized as belonging to the wild type (WT) for aspecies by applying the appropriate cut-off value.

this cut-off value will not be altered by changing circumstances

Microbiological resistance - Non-Wild Type (NWT>X mg/L)

microbiological resistance is defined as the presence of an acquiredresistance mechanism to the drug in question.

categorized as resistant (R) by applying the appropriate cut-off value in adefined phenotypic test system

this cut-off value will not be altered by changing circumstances microbiological resistance may or may not affect clinical response to

antimicrobial treatment