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Preserving old antibiotics for the future : assessment of clinical efficacy by a pharmacokinetic/pharmacodynamic approach to optimize effectiveness and reduce resistance for off-patent antibiotics

Ziel

The AIDA project aims to answer the question of clinical effectiveness and optimal dosing of 5 off-patent antibiotics for infections caused by multiple drug resistant (MDR) bacteria in three randomized controlled clinical trials. In an era of increasing emergence of drug resistance (EDR) and lack of new antibiotics, old off- patent antibiotics are increasingly being prescribed to patients. However, many of these were developed in an age before the advent of a structured process for drug assessment and approval, and the establishment of clinical efficacy and effectiveness in randomized controlled trials in particular. In a multidisciplinary approach the exposure response relationships for each antibiotic will be elucidated by including pharmacokinetic (PK), pharmacodynamic (PD) and microbiological studies, including emergence of drug resistance (EDR). The project addresses the optimization of treatment of infections caused by MDR pathogens that impose a major burden of disease in Europe and the rest of the world by selecting 5 off-patent-antibiotics that are increasingly being used without clear evidence with respect to their effectiveness, duration of therapy and issues of EDR. In the first trial the efficacy of colistin alone is compared to colistin plus imipenem for severe infections caused by carbapenem-resistant bacteria. The second trial compares fosfomycin vs. nitrofurantoin for the treatment of lower urinary tract infection in women at high risk of antibiotic-resistant pathogens. In the third trial antimicrobial oral treatment with minocycline plus rifampicin is compared with oral treatment with linezolid for complicated skin and soft tissue infections (cSSTI) due to MRSA. Exposure – response relationships, PK/PD and EDR issues will be addressed in a separate project component and is an essential element of the research project that will interrelate synergistically with the clinical studies. The results thereof will be used to refine exposure response relationships but also to study effects of exposure that are not readily observed in the trials. This will aid to delineate optimal exposures and drug dosing. This project addresses an urgent medical need that is critical both for individual patients and for society. An effective dissemination strategy is essential to effectively communicate project results to the target groups therefore supporting the project goal of preserving and strengthening the public health benefits of the studied off-patent antibiotics. The dissemination of project results to professional groups and the public in general, communication to policymakers, and implementation of results in national formularies is an important aspect.

Wissenschaftliches Gebiet

  • /Medizin- und Gesundheitswissenschaften/Gesundheitswissenschaften/öffentliche Gesundheit und Umweltschutz
  • /Medizin- und Gesundheitswissenschaften/Grundlagenmedizin/Pharmakologie und Pharmazie/Arzneimittelresistenz
  • /Medizin- und Gesundheitswissenschaften/Grundlagenmedizin/Pharmakologie und Pharmazie/Arzneimittelresistenz/Multiresistenz

Aufforderung zur Vorschlagseinreichung

FP7-HEALTH-2011-two-stage
Andere Projekte für diesen Aufruf anzeigen

Finanzierungsplan

CP-FP - Small or medium-scale focused research project

Koordinator

ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM
Adresse
Dr Molewaterplein 40
3015 GD Rotterdam
Niederlande
Aktivitätstyp
Higher or Secondary Education Establishments
EU-Beitrag
€ 657 960
Kontakt Verwaltung
Ramprasath Venkatachalam (Dr.)

Beteiligte (18)

TEL AVIV UNIVERSITY
Israel
EU-Beitrag
€ 607 217
Adresse
Ramat Aviv
69978 Tel Aviv
Aktivitätstyp
Higher or Secondary Education Establishments
Kontakt Verwaltung
Lea Pais (Ms.)
THE FOUNDATION FOR MEDICAL RESEARCH INFRASTRUCTURAL DEVELOPMENT AND HEALTH SERVICES NEXT TO THE MEDICAL CENTER TEL AVIV
Israel
EU-Beitrag
€ 463 760
Adresse
Weizmann Street 6
64239 Tel Aviv
Aktivitätstyp
Research Organisations
Kontakt Verwaltung
Michal Roll (Dr.)
UPPSALA UNIVERSITET
Schweden
EU-Beitrag
€ 147 600
Adresse
Von Kraemers Alle 4
751 05 Uppsala
Aktivitätstyp
Higher or Secondary Education Establishments
Kontakt Verwaltung
Katarina Edberg (Ms.)
STATENS SERUM INSTITUT
Dänemark
EU-Beitrag
€ 42 000
Adresse
Artillerivej 5
2300 Kobenhavn S
Aktivitätstyp
Research Organisations
Kontakt Verwaltung
Torben Theilmann (Mr.)
UNIVERSITE DE GENEVE
Schweiz
EU-Beitrag
€ 656 600
Adresse
Rue Du General Dufour 24
1211 Geneve
Aktivitätstyp
Higher or Secondary Education Establishments
Kontakt Verwaltung
Fabricio Jantarada (Mr.)
ETHNIKO KAI KAPODISTRIAKO PANEPISTIMIO ATHINON
Greece
EU-Beitrag
€ 276 000
Adresse
6 Christou Lada Str
10561 Athina
Aktivitätstyp
Higher or Secondary Education Establishments
Kontakt Verwaltung
Efstathia Kafentzi (Ms.)
NORTH BRISTOL NATIONAL HEALTH SERVICE TRUST
United Kingdom
EU-Beitrag
€ 283 280
Adresse
Southmead Hospital, Southmead Road, Westbury On Trym
BS10 5NB Bristol
Aktivitätstyp
Research Organisations
Kontakt Verwaltung
Alasdair Macgowan (Prof.)
Ursula Theuretzbacher
Österreich
EU-Beitrag
€ 300 000
Adresse
Eckpergasse
1180 Vienna
Aktivitätstyp
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Kontakt Verwaltung
Ursula Theuretzbacher (Dr.)
MICRON RESEARCH LIMITED
United Kingdom
EU-Beitrag
€ 1 320 000
Adresse
Park Street Zion Building
PE16 6AE Chatteris
Aktivitätstyp
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Kontakt Verwaltung
Miriam O'hare (Dr.)
UNIVERSITE DE POITIERS
Frankreich
EU-Beitrag
€ 36 600
Adresse
Rue De L Hotel Dieu 15 Hotel Pinet
86034 Poitiers Cedex
Aktivitätstyp
Higher or Secondary Education Establishments
Kontakt Verwaltung
Michel Palos Pinto (Mr.)
UNIVERSYTET MEDYCZNY W LODZI.
Polen
EU-Beitrag
€ 187 500
Adresse
Al. Kosciuszki, 4
90419 Lodz
Aktivitätstyp
Higher or Secondary Education Establishments
Kontakt Verwaltung
Maciej Godycki-Cwirko (Dr.)
UNIVERSITA CATTOLICA DEL SACRO CUORE

Beteiligung beendet

Italien
EU-Beitrag
€ 26 754,98
Adresse
Largo Gemelli 1
20123 Milano
Aktivitätstyp
Higher or Secondary Education Establishments
Kontakt Verwaltung
Filippo Leone (Mr.)
THE UNIVERSITY OF MANCHESTER

Beteiligung beendet

United Kingdom
Adresse
Oxford Road
M13 9PL Manchester
Aktivitätstyp
Higher or Secondary Education Establishments
Kontakt Verwaltung
Katherine Boylan (Dr.)
THE UNIVERSITY OF LIVERPOOL
United Kingdom
EU-Beitrag
€ 99 600
Adresse
Brownlow Hill 765 Foundation Building
L69 7ZX Liverpool
Aktivitätstyp
Higher or Secondary Education Establishments
Kontakt Verwaltung
Jenny Lawson (Ms.)
THE HEALTH CORPORATION - RAMBAM
Israel
EU-Beitrag
€ 465 385
Adresse
Haaliya 8
31096 Haifa
Aktivitätstyp
Research Organisations
Kontakt Verwaltung
Rivka Sevy (Dr.)
UNIVERSITA DEGLI STUDI DELLA CAMPANIA LUIGI VANVITELLI
Italien
EU-Beitrag
€ 83 760
Adresse
Viale Abramo Lincoln 5
81100 Caserta
Aktivitätstyp
Higher or Secondary Education Establishments
Kontakt Verwaltung
Rosa Santo (Dr.)
STICHTING KATHOLIEKE UNIVERSITEIT
Niederlande
EU-Beitrag
€ 345 843,02
Adresse
Geert Grooteplein Noord 9
6525 EZ Nijmegen
Aktivitätstyp
Higher or Secondary Education Establishments
Kontakt Verwaltung
Wim Van Oijen (Mr.)
Clinical Center of Serbia

Beteiligung beendet

Serbien
Adresse
Pasterova 2
11000 Belgrade
Aktivitätstyp
Higher or Secondary Education Establishments
Kontakt Verwaltung
Biljana Carevic (Dr.)