On 18th and 19th December 2018, the 7° Network Governing Council Meeting and the 4° Investigators Meeting of the NeoVanc project will be held in Athens at the Collaborative Center for Clinical Epidemiology and Outcomes Research – CLEO.
The meeting will be aimed to provide an update on the project progress and in particular on the NeoVanc study (eg statistical plan, preliminary PK analysis).
NeoVanc (Treatment of late onset bacterial sepsis caused by vancomycin susceptible bacteria in neonates and infants aged under three months) is an EU funded project started in March 2017 and aimed at marketing a new formulation of vancomycin for the treatment of neonatal sepsis in patients up to 3 months of age. So far, 179 patients have been recruited (the project aims to enrol 300 patients).
Throughout the project, preclinical studies and a clinical trial are ongoing in accordance with the Paediatric Investigation Plan (PIP) approved by the Paediatric Committee at the European Medicines Agency. Such studies are intended at defining the pharmacokinetics of this antibiotic as well as at identifying the optimal dosages for its use in the neonatal population.
The achieved results will support the application for a Paediatric Use Marketing Authorisation (PUMA) of the formulation intended for neonates and infants under 3 months of life. Within the project, CVBF is responsible for regulatory management including support to PIP implementation, clinical trial authorisation process, data management and pharmacovigilance activities.
The closure of the project is scheduled for January 2019, however the EC has granted an 18months extension.
Further information are available here.