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 contact info |
| 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
| # | ||||
|---|---|---|---|---|
| 1 |
FONDAZIONE PENTA-FOR THE TREATMENT AND CARE OF CHILDREN WITH HIV-ONLUS
Organization address
address: CORSO STATI UNITI 4 contact info |
IT (PADOVA) | coordinator | 357˙604.00 |
| 2 |
Therakind Ltd
Organization address
address: DOLLIS PARK ROAD WINSTON HOUSE 2 contact info |
UK (London) | participant | 1˙903˙100.00 |
| 3 |
THE UNIVERSITY OF LIVERPOOL
Organization address
address: Brownlow Hill, Foundation Building 765 contact info |
UK (LIVERPOOL) | participant | 650˙824.00 |
| 4 |
ST GEORGE'S HOSPITAL MEDICAL SCHOOL
Organization address
address: Cranmer Terrace contact info |
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 contact info |
FR (PARIS) | participant | 451˙840.00 |
| 6 |
CONSORZIO PER VALUTAZIONI BIOLOGICHE E FARMACOLOGICHE
Organization address
address: VIA LUIGI PORTA 14 contact info |
IT (PAVIA) | participant | 419˙554.00 |
| 7 |
OSPEDALE PEDIATRICO BAMBINO GESU
Organization address
address: PIAZZA SAN ONOFRIO 4 contact info |
IT (ROMA) | participant | 391˙758.00 |
| 8 |
ARISTOTELIO PANEPISTIMIO THESSALONIKIS
Organization address
address: Administration Building, University Campus contact info |
EL (THESSALONIKI) | participant | 336˙900.00 |
| 9 |
TARTU ULIKOOL
Organization address
address: ULIKOOLI 18 contact info |
EE (TARTU) | participant | 303˙024.00 |
| 10 |
SYNAPSE RESEARCH MANAGEMENT PARTNERS SL
Organization address
address: CALLE LLACUNA 162 contact info |
ES (BARCELONA) | participant | 241˙152.00 |
| 11 |
SERVICIO MADRILENO DE SALUD
Organization address
address: PLAZA CARLOS TRIAS BERTRAN 7 contact info |
ES (MADRID) | participant | 162˙048.00 |
| 12 |
THE UNIVERSITY OF EDINBURGH
Organization address
address: OLD COLLEGE, SOUTH BRIDGE contact info |
UK (EDINBURGH) | participant | 124˙752.00 |
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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.'