Transcript EUCAST Report to ESCMID board 2003-03-27

EUCAST
Chairman´s report to the ESCMID
February 28, 2003
Gunnar Kahlmeter
Chairman 2002 – 2004
EUCAST
ESCMID board
EUCAST general committe
EUCAST steering committe
EUCAST general committee 2003
Austria Prof Helmut Mittermayer
Belgium Prof Jan Verhaegen
Bosnia Dr Selma Uzunovic-Kamberovic
Bulgaria Prof Krassimir Metodiev
Croatia Dr Arjana Tambic-Andrasevic
Czech Republic Dr Pavla Urbaskova
Denmark Dr Niels Frimodt-Møller
Estonia Dr Paul Naaber
Finland Dr Antti Nissinen
France Dr Fred W. Goldstein
Germany Prof Bernd Wiedemann
Greece Prof Alkiviadis Vatopoulos
Hungary Dr Éva Bán
Iceland Dr Karl Gustaf Kristinsson
Ireland Dr Martin Cormican
Italy Prof Enrico Magliano
Lithuania Prof Arvydsa Ambrozaitis
Netherlands Prof John Degener
Norway Dr Martin Steinbakk
Poland Prof Waleria Hryniewicz
Portugal Prof Jose Melo Cristino
Romania no official representative
Russia Prof Sergei Sidorenko
Serbia Dr Lazar Ranin
Slovak Republic Prof. Milan Niks
Slovenia Dr Jana Kolman
Spain Dr Francisco Soriano
Sweden Dr Barbro Olsson-Liljequist
Switzerland Prof Jaques Bille
Turkey Dr Deniz Gür
UK Prof Richard Wise
Yugoslavia representative not confirmed
Pharmaceutical Industry Representatives
Prof. André Bryskier, Hoechst Marion Roussel
Rep 2 not nominated
Device Manufacturers Representatives
Dr. 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 committee
2002 - 2004
• Gunnar Kahlmeter, chairman
• Derek Brown, Scientific secretary
2004
2004
• Alasdair MacGowan, BSAC (The UK)
• Fred Goldstein, CA-SFM (France)
• Johan W. Mouton, CRG (Netherlands)
• Arne Rodloff, DIN (Germany)
• Martin Steinbakk, NWGA (Norway)
• Anders Österlund, SRGA (Sweden)
• Pavla Urbaskova (Czech Republic), EUCAST rep 1
• Alkiviadis Vatopoulos (Greece), EUCAST rep 2
2004
2004
2004
2004
2004
2004
2003
2003
EUCAST steering committee 28th of January, 2003
EUCAST appointments
ESCMID appoints
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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.
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European countries
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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 appointment
Activities in bold - paid by ESCMID
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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 Paris
OEI (Orgainzation Epizotic International) in Paris
EARSS meeting in Vienna
RIVM and EARSS, Amsterdam
BSAC in Birmingham
ESCMID board meeting in Venice
NEQAS in London
NWGA in Oslo
ESCMID board meeting in Italy
ECCMID - EUCAST workshop/meeting Milan
EARSS advisory board meetings in Bilthoven
ECC in Paris
IACMAC meeting in Moscow
EARSS report 2001 - Amsterdam
ICAAC in San Diego
EUCAST reference database programme
EARSS meeting in Bath
Steering committee meeting in Shiphol
Leading article on QA in JAC (DB and GK)
NCCLS, Tampa, USA
Steering committee meeting, Frankfurt
ESCMID board meeting in Amsterdam
EUCAST 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-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 2003
Derek 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 DGSANCO, ISC/FESCI, FEMS, EFPIA, can be obtained in progress!
EUCAST is represented on
• The national breakpoint committees
• EARSS
• NCCLS
The EUCAST steering committee has
defined…
Clinical breakpoints
S< X and R> Y mg/L
New definitions of clinical breakpoints (S, I & R).
Epidemiological cut-off values
WT < Z mg/L
Definitions of wild type and epidemiological cutoff values (WT and NWT).
The EUCAST steering committee has…
• Closed all subcommittees except the subcommittee on
antifungal susceptibility testing (EUCAST AFST)
• Decided on a common expression for S< and R>
•Decided on a common MIC microbroth dilution method
as reference gold standard.
• Decided on a process for setting breakpoints for new
antibiotics (try outs: daptomycin, garenoxacin – both
companies contacted)
• Decided on a process for harmonising breakpoints for
existing antibiotics (fluoroquinolones successfully done,
aminoglycosides, glycopeptides and linezolid is on)
• Proposed definitions for wild type bacteria and
epidemiological cut-off values
EUCAST 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:
”Antimicrobial wild type distributions”
with EUCAST clinical breakpoints and
epidemiological 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
development: 3000 euro + VAT
Approximately 750 distributions have been entered.
Aggregated Ciprofloxacin/E.coli MICdistributions from 6 separate data sources
(national breakpoint committees, Antimicrobial
resistance surveillance programs, EARSS, drug
company data etc)
EUCAST – 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 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 (?)
Tentative new EUCAST definitions of S, I and R
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 of
therapeutic failure.
 a micro-organism is categorized as resistant (R) by applying the
appropriate breakpoint in a defined phenotypic test system
 This breakpoint may be altered with legitimate changes in
circumstances
Clinical breakpoints are given as S<X mg/L, R>Y mg/L
Microbiological resistance and epidemiological
cut-off values
Wild type (WT<X mg/L)
 a micro-organism is defined as belonging to the wild type (WT) for a species
by the absence of acquired resistance mechanisms to the drug in question.
 a micro-organism is categorized as belonging to the wild type (WT) for a
species 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 acquired
resistance mechanism to the drug in question.
 categorized as resistant (R) by applying the appropriate cut-off value in a
defined 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