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Treatment of late onset bacterial sepsis caused by vancomycin susceptible bacteria in neonates and infants aged under three months

Objective

Vancomycin is the critically important antibiotic to treat neonatal Late Onset Sepsis (LOS) due to Gram positive bacteria in neonates, including Coagulase Negative Staphylococci (CoNS) and Staphylococcus aureus. These organisms also create biofilms which are extremely resistant to antibiotics. The increased incidence of LOS due to bacteria such as CoNS and MRSA in NICUs has led to a marked increased use of vancomycin, which is now the third commonest antibiotic used in European NICUs. However, a standardised dosing regimen for premature infants has not yet been defined and there is no data about the serum concentrations needed to ensure bacterial kill for CoNS in humans. In view of the lack of any firm dosage for neonates and infants, vancomycin has been included in the EMA list of off-patent drugs addressing unmet therapeutic needs in children. Accordingly NeoVanc consortium has already submitted a Paediatric Investigation Plan (PIP) which has provisionally received a favourable 120 day opinion and this application is built on what is included in the approved PIP. This project aims to:-develop a new age-appropriate formulation of vancomycin; define the circulating concentration of vancomycin that is needed to kill CoNS in in vitro biofilm and animal model, and use that data to derive the concentration and best PD target that will be maximally effective in neonates; define the neonatal dosage that is needed to attain the concentration that can kill CoNS and enterococci by conducting a systematic meta-analysis of all available PK data and develop an optimal dosing and therapeutic drug monitoring regimen. NeoVanc will then conduct a Phase 2 b randomised clinical trial to compare the proportion of neonates reaching the PD target derived from the pre-clinical studies when treated with the current standard vs new “optimised” treatment regimens and to obtain data on dosing, efficacy and short and long-term safety to be included in the SPCs leading to a PUMA.

Call for proposal

FP7-HEALTH-2013-INNOVATION-1
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Coordinator

FONDAZIONE PENTA ONLUS
Address
Corso Stati Uniti 4
35127 Padova
Italy

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Activity type
Research Organisations
Administrative Contact
Davide Bilardi (Dr.)
EU contribution
€ 653 369,93

Participants (12)

ST GEORGE'S HOSPITAL MEDICAL SCHOOL
United Kingdom
EU contribution
€ 721 526,15
Address
Cranmer Terrace
SW17 0RE London

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Steff Hazlehurst (Ms.)
INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE
France
EU contribution
€ 317 213,50
Address
Rue De Tolbiac 101
75654 Paris

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Activity type
Research Organisations
Administrative Contact
Isabelle Pires (Ms.)
TARTU ULIKOOL
Estonia
EU contribution
€ 267 409,50
Address
Ulikooli 18
51005 Tartu

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Irja Lutsar (Prof.)
CONSORZIO PER VALUTAZIONI BIOLOGICHE E FARMACOLOGICHE
Italy
EU contribution
€ 411 388
Address
Via Nicolo Putignani 178
70122 Bari

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Activity type
Research Organisations
Administrative Contact
Ilaria Bergonzi (Dr.)
THE UNIVERSITY OF LIVERPOOL
United Kingdom
EU contribution
€ 604 436
Address
Brownlow Hill 765 Foundation Building
L69 7ZX Liverpool

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Jenny Lawson (Ms.)
Therakind Ltd
United Kingdom
EU contribution
€ 1 931 614,25
Address
Dollis Park Road Winston House 2
NE 1HF London

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Louise Rawcliffe (Ms.)
OSPEDALE PEDIATRICO BAMBINO GESU
Italy
EU contribution
€ 346 045
Address
Piazza Sant Onofrio 4
00165 Roma

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Activity type
Research Organisations
Administrative Contact
Sonya Jane Martin (Dr.)
SERVICIO MADRILENO DE SALUD
Spain
EU contribution
€ 126 771,60
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
Mar Lopez Martin (Ms.)
ARISTOTELIO PANEPISTIMIO THESSALONIKIS
Greece
EU contribution
€ 363 822,05
Address
Kedea Building, Tritis Septemvriou, Aristotle Univ Campus
54636 Thessaloniki

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Georgia Petridou (Ms.)
THE UNIVERSITY OF EDINBURGH

Participation ended

United Kingdom
EU contribution
€ 13 610,21
Address
Old College, South Bridge
EH8 9YL Edinburgh

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Angela Noble (Ms.)
SYNAPSE RESEARCH MANAGEMENT PARTNERS SL

Participation ended

Spain
EU contribution
€ 128 347,85
Address
Calle Velazquez 94 Planta 1
28006 Madrid

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Sandra Pla (Ms.)
CARDIFF UNIVERSITY
United Kingdom
EU contribution
€ 107 445,96
Address
Newport Road 30 36
CF24 0DE Cardiff

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Keith Sextone (Dr.)