NEOMERO – European multicenter network to evaluate PK, safety and efficacy of Meropenem in neonatal sepsis and meningitis

NEOMERO – European multicenter network to evaluate PK, safety and efficacy of Meropenem in neonatal sepsis and meningitis 2016-01-05T11:38:33+00:00

Logo NEOMERO project

Website

www.neomero.org

Role of CVBF

Partner

Description

The goal of the NeoMero project is the registration and commercialisation in Europe of meropenem, an antibiotic so far used off-label for the treatment of sepsis and bacterial meningitis in neonates.

To this end, a paediatric development plan has been set which includes the conduction of two clinical studies aimed to evaluate the pharmacokinetics, safety and efficacy profile of this medicine in children under 3 months of age.

The achieved results will support the application for a Paediatric Use Marketing Authorisation (PUMA) of this product, which will be thus available to the entire paediatric population.

Funds

Seventh Framework Programme, European Commission

Budget

7.7 milioni di euro

EU Contribution

5.9 milioni di euro

Duration

2010-2014

Partners

(1) Fondazione PENTA (PENTA), Italy; (2) Ospedale Pediatrico Bambino Gesú (OPBG), Italy; (3) Università degli Studi di Milano (UMIL), Italy; (4) St George’s Hospital Medical School (SGUL), UK; (5) Institut National de la Santé et de la Recherche Médicale (INSERM-CTU), France;  (6) ESPID Foundation (ESPID),  Germany; (7) University of Tartu (UTARTU), Estonia; (8) Radboud University Nijmegen Medical Centre (RUNMC), The Netherlands; (9) Aristotle University (AUTH), Greece; (10) Vilnius University Children Hospital (VUCH), Lithuania; (11) University Hospital La Paz. Fundación para la Investigación Biomédica (SERMAS), Spain; (12) Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF), Italy.