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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

Objective

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.

Call for proposal

FP7-HEALTH-2011-two-stage
See other projects for this call

Coordinator

ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM
Address
Dr Molewaterplein 40
3015 GD Rotterdam
Netherlands
Activity type
Higher or Secondary Education Establishments
EU contribution
€ 657 960
Administrative Contact
Ramprasath Venkatachalam (Dr.)

Participants (18)

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

Participation ended

Italy
EU contribution
€ 26 754,98
Address
Largo Gemelli 1
20123 Milano
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Filippo Leone (Mr.)
THE UNIVERSITY OF MANCHESTER

Participation ended

United Kingdom
Address
Oxford Road
M13 9PL Manchester
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Katherine Boylan (Dr.)
THE UNIVERSITY OF LIVERPOOL
United Kingdom
EU contribution
€ 99 600
Address
Brownlow Hill 765 Foundation Building
L69 7ZX Liverpool
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Jenny Lawson (Ms.)
THE HEALTH CORPORATION - RAMBAM
Israel
EU contribution
€ 465 385
Address
Haaliya 8
31096 Haifa
Activity type
Research Organisations
Administrative Contact
Rivka Sevy (Dr.)
UNIVERSITA DEGLI STUDI DELLA CAMPANIA LUIGI VANVITELLI
Italy
EU contribution
€ 83 760
Address
Viale Abramo Lincoln 5
81100 Caserta
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Rosa Santo (Dr.)
STICHTING RADBOUD UNIVERSITEIT
Netherlands
EU contribution
€ 345 843,02
Address
Houtlaan 4
6525 XZ Nijmegen
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Wim Van Oijen (Mr.)
Clinical Center of Serbia

Participation ended

Serbia
Address
Pasterova 2
11000 Belgrade
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Biljana Carevic (Dr.)