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Therapeutic Beta-Lactam Monitoring for Stratified Treatment of hospital-acquired pneumonia, improved dose-dependent efficacy, decreased treatment duration, and prevention of emergence of resistance

Objective

Stratified clinical treatment interventions meeting patient-specific efficacy (pharmacodynamics) while at the same time lowering the risk of emergence of drug resistance (EDR) and minimizing adverse effects are particularly needed in Hospital-acquired and Ventilator-Associated pneumonia [HAP/VAP] where morbidity, mortality and health care costs remain high. β-lactam antibiotics are at the cornerstone of most effective treatments of HAP/VAP, but dosage adaptations remain difficult because available models (i) focus mainly on efficacy (neglecting EDR and dose-related side effects) and (ii) are derived from population data which imperfectly fit individual patient’s needs due to large, rapid and difficult-to-predict variations of blood levels.
Current methods for monitoring β-lactam blood levels are slow and require complex instruments not usable at bed-side. Yet, generating easily, rapidly and cost-effectively real data usable at the patient’s bed-side should improve outcomes of β-lactam treatments. This is what 3 out of the 11 partners of the MON4STRAT consortium have recently developed (patent pending).
Thus the objective of the Project is to integrate both (i) state-of-the-art PK/PD and EDR profiles AND (ii) real-time/patient-specific free β-lactam blood levels monitored at the patient’s bed-side according to the patented assay for developing and implementing a new approach to (i) stratify the HAP/VAP patients according to their specific response, (ii) to propose immediately applicable dose adjustments during treatment and thus (iii) to improve efficacy while reducing risk of EDR or adverse effects.
The MON4STRAT approach will be validated through a prospective, multicentre, randomized clinical trial with150 adults. Its applicability in paediatrics will be tested through an observational study with 70 children/neonates.
Being generic in nature, MON4STRAT will be replicable to other infectious conditions.

Call for proposal

FP7-HEALTH-2013-INNOVATION-1
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Coordinator

UNIVERSITE DE LIEGE
Address
Place Du 20 Aout 7
4000 Liege
Belgium

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Isabelle Halleux (Ms.)
EU contribution
€ 1 472 610

Participants (11)

UNIVERSITE CATHOLIQUE DE LOUVAIN
Belgium
EU contribution
€ 827 540
Address
Place De L Universite 1
1348 Louvain La Neuve

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Francoise Vanbambeke (Prof.)
WOW TECHNOLOGY

Participation ended

Belgium
EU contribution
€ 1 078 120,38
Address
Rue Pieds D'alouette 18
5100 Naninne

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Jean Demarteau (Mr.)
INST CARDIOMETABOLISME NUTRITION ICAN
France
EU contribution
€ 268 334,40
Address
Boulevard De L'hopital 47-83
75013 Paris

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Activity type
Research Organisations
Administrative Contact
Jean Chastre (Prof.)
SERVICIO MADRILENO DE SALUD
Spain
EU contribution
€ 511 162,40
Address
Plaza Carlos Trias Bertran 7
28020 Madrid

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Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
José Ignacio Flores Nicolás (Mr.)
UNIVERSITY OF HOUSTON SYSTEM
United States
EU contribution
€ 400 600,10
Address
Ezekiel Cullen Building 203
772042022 Houston

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Beverly Rymer
UNIVERSITE LIBRE DE BRUXELLES
Belgium
EU contribution
€ 384 710
Address
Avenue Franklin Roosevelt 50
1050 Bruxelles

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Christine Courillon (Dr.)
CENTRE HOSPITALIER REGIONAL ET UNIVERSITAIRE DE LILLE
France
EU contribution
€ 251 091,72
Address
Avenue Oscar Lambret 2
59037 Lille

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Bernadette Lucas (Dr.)
TARTU ULIKOOL
Estonia
EU contribution
€ 209 272
Address
Ulikooli 18
51005 Tartu

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Irja Lutsar (Prof.)
SGS EXPRIMO NV
Belgium
EU contribution
€ 145 500
Address
Generaal De Wittelaan 19a
2800 Mechelen

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Philippe Jacqmin (Dr.)
AEPODIA SA
Belgium
EU contribution
€ 394 400
Address
Rue Louis De Geer 6
1348 Ottignies Louvain La Neuve

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Denis Gossen (Dr.)
ASSISTANCE PUBLIQUE HOPITAUX DE PARIS
France
EU contribution
€ 45 600
Address
3 Avenue Victoria
75000 Paris

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Activity type
Research Organisations
Administrative Contact
Catherine Tostain Desmares (Ms.)