NEOVANC

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

 Coordinatore FONDAZIONE PENTA-FOR THE TREATMENT AND CARE OF CHILDREN WITH HIV-ONLUS 

 Organization address address: CORSO STATI UNITI 4
city: PADOVA
postcode: 35127

contact info
Titolo: Dr.
Nome: Davide
Cognome: Bilardi
Email: send email
Telefono: +39 0498215447
Fax: +39 0499640123

 Nazionalità Coordinatore Italy [IT]
 Totale costo 7˙882˙015 €
 EC contributo 5˙993˙000 €
 Programma FP7-HEALTH
Specific Programme "Cooperation": Health
 Code Call FP7-HEALTH-2013-INNOVATION-1
 Funding Scheme CP-FP
 Anno di inizio 2014
 Periodo (anno-mese-giorno) 2014-02-01   -   2019-01-31

 Partecipanti

# participant  country  role  EC contrib. [€] 
1    FONDAZIONE PENTA-FOR THE TREATMENT AND CARE OF CHILDREN WITH HIV-ONLUS

 Organization address address: CORSO STATI UNITI 4
city: PADOVA
postcode: 35127

contact info
Titolo: Dr.
Nome: Davide
Cognome: Bilardi
Email: send email
Telefono: +39 0498215447
Fax: +39 0499640123

IT (PADOVA) coordinator 357˙604.00
2    Therakind Ltd

 Organization address address: DOLLIS PARK ROAD WINSTON HOUSE 2
city: London
postcode: NE 1HF

contact info
Titolo: Ms.
Nome: Louise
Cognome: Rawcliffe
Email: send email
Telefono: +44 2083646032

UK (London) participant 1˙903˙100.00
3    THE UNIVERSITY OF LIVERPOOL

 Organization address address: Brownlow Hill, Foundation Building 765
city: LIVERPOOL
postcode: L69 7ZX

contact info
Titolo: Ms.
Nome: Jenny
Cognome: Lawson
Email: send email
Telefono: +44 1517950314
Fax: +44 1517948728

UK (LIVERPOOL) participant 650˙824.00
4    ST GEORGE'S HOSPITAL MEDICAL SCHOOL

 Organization address address: Cranmer Terrace
city: LONDON
postcode: SW17 0RE

contact info
Titolo: Ms.
Nome: Steff
Cognome: Hazlehurst
Email: send email
Telefono: +44 2087255012
Fax: +44 2087250794

UK (LONDON) participant 650˙444.00
5    INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)

 Organization address address: 101 Rue de Tolbiac
city: PARIS
postcode: 75654

contact info
Titolo: Ms.
Nome: Isabelle
Cognome: Pires
Email: send email
Telefono: +33 143622724
Fax: +33 143622701

FR (PARIS) participant 451˙840.00
6    CONSORZIO PER VALUTAZIONI BIOLOGICHE E FARMACOLOGICHE

 Organization address address: VIA LUIGI PORTA 14
city: PAVIA
postcode: 27100

contact info
Titolo: Dr.
Nome: Ilaria
Cognome: Bergonzi
Email: send email
Telefono: +39 038225075
Fax: +39 0382536544

IT (PAVIA) participant 419˙554.00
7    OSPEDALE PEDIATRICO BAMBINO GESU

 Organization address address: PIAZZA SAN ONOFRIO 4
city: ROMA
postcode: 165

contact info
Titolo: Dr.
Nome: Sonya Jane
Cognome: Martin
Email: send email
Telefono: +39 0668592577
Fax: +39 0668592101

IT (ROMA) participant 391˙758.00
8    ARISTOTELIO PANEPISTIMIO THESSALONIKIS

 Organization address address: Administration Building, University Campus
city: THESSALONIKI
postcode: 54124

contact info
Titolo: Ms.
Nome: Georgia
Cognome: Petridou
Email: send email
Telefono: +30 23100995140
Fax: +30 2310853283

EL (THESSALONIKI) participant 336˙900.00
9    TARTU ULIKOOL

 Organization address address: ULIKOOLI 18
city: TARTU
postcode: 50090

contact info
Titolo: Prof.
Nome: Irja
Cognome: Lutsar
Email: send email
Telefono: +37 27374171
Fax: 3727374172

EE (TARTU) participant 303˙024.00
10    SYNAPSE RESEARCH MANAGEMENT PARTNERS SL

 Organization address address: CALLE LLACUNA 162
city: BARCELONA
postcode: 8018

contact info
Titolo: Ms.
Nome: Sandra
Cognome: Pla
Email: send email
Telefono: +34 933006061

ES (BARCELONA) participant 241˙152.00
11    SERVICIO MADRILENO DE SALUD

 Organization address address: PLAZA CARLOS TRIAS BERTRAN 7
city: MADRID
postcode: 28020

contact info
Titolo: Ms.
Nome: Mar
Cognome: Lopez Martin
Email: send email
Telefono: +34 917792839

ES (MADRID) participant 162˙048.00
12    THE UNIVERSITY OF EDINBURGH

 Organization address address: OLD COLLEGE, SOUTH BRIDGE
city: EDINBURGH
postcode: EH8 9YL

contact info
Titolo: Ms.
Nome: Angela
Cognome: Noble
Email: send email
Telefono: +44 1316509034
Fax: +44 1316514028

UK (EDINBURGH) participant 124˙752.00

Mappa


 Word cloud

Esplora la "nuvola delle parole (Word Cloud) per avere un'idea di massima del progetto.

antibiotic    kill    los    cons    pd    clinical    neonates    regimen    dosing    neovanc    dosage    neonatal    data    infants    therapeutic    vancomycin    pip    nicus    concentration    bacteria   

 Obiettivo del progetto (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.'

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