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

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.

Coordinator

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

Address

Corso Stati Uniti 4
35127 Padova

Italy

Activity type

Research Organisations

EU Contribution

€ 679 925,70

Administrative Contact

Davide Bilardi (Dr.)

Participants (11)

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ST GEORGE'S HOSPITAL MEDICAL SCHOOL

United Kingdom

EU Contribution

€ 729 284,80

INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE

France

EU Contribution

€ 317 740

TARTU ULIKOOL

Estonia

EU Contribution

€ 266 769,60

CONSORZIO PER VALUTAZIONI BIOLOGICHE E FARMACOLOGICHE

Italy

EU Contribution

€ 412 204

THE UNIVERSITY OF LIVERPOOL

United Kingdom

EU Contribution

€ 561 064

Therakind Ltd

United Kingdom

EU Contribution

€ 1 934 750

OSPEDALE PEDIATRICO BAMBINO GESU

Italy

EU Contribution

€ 346 623,25

SERVICIO MADRILENO DE SALUD

Spain

EU Contribution

€ 127 110

ARISTOTELIO PANEPISTIMIO THESSALONIKIS

Greece

EU Contribution

€ 364 428,80

THE UNIVERSITY OF EDINBURGH

United Kingdom

EU Contribution

€ 124 752

SYNAPSE RESEARCH MANAGEMENT PARTNERS SL

Spain

EU Contribution

€ 128 347,85

Project information

Grant agreement ID: 602041

Status

Closed project

  • Start date

    1 February 2014

  • End date

    31 January 2019

Funded under:

FP7-HEALTH

  • Overall budget:

    € 7 731 456,44

  • EU contribution

    € 5 993 000

Coordinated by:

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

Italy