CloSed – Clonidine for Sedation of Paediatric Patients in the Intensive Care Unit

CloSed – Clonidine for Sedation of Paediatric Patients in the Intensive Care Unit 2018-09-20T17:23:21+00:00

CloSed Project LogoWebsite

www.closed-fp7.eu

Role of FGB-CVBF

Partner

Description

CloSed (Clonidine for Sedation of Paediatric Patients in the Intensive Care Unit) is a 5-year project funded under the Seventh Framework Programme (FP7) with an international Consortium comprising 10 European partners and coordinated by Assoc. Prof. Antje Neubert, University Hospital of Erlangen (UKER).

The project aims to perform a multicentre and multinational paediatric clinical trial studying clonidine, a drug already used for sedation in Pediatric Intensive Care Units (PICUs) but not authorised in paediatric population. The ultimate goal is to make a parenteral age-appropriate formulation of clonidine available on the market for sedation in PICUs and to apply for a Paediatric Use Marketing Authorisation (PUMA). Furthermore, the CloSed project partners will use the findings of the clinical trial to develop and disseminate European consensus guidelines for sedation in critically ill newborns and children which will support all clinicians across Europe in their decisions.

CVBF is involved in the CloSed project as FGB (Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus) Third Party and is in charge of Pharmacovigilance activities.

Funds

Seventh Framework Programme, European Commission

Budget

7.4 million euro

EU Contribution

6 million euro

Duration

2013 -2018

Partners

(1) Universitaetsklinikum Erlangen (UKER), Germany (Coordinator); (2) University College London (UCL), UK; (3) Therakind, UK; (4) Erasmus Universitair Medisch Centrum Rotterdam (EMC), The Netherlands; (5) Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus (FGB), Italy; (6) Karolinska Institutet (KI), Sweden; (7) Tartu Ulikool (UTARTU), Estonia; (8) Univerzita Karlova V Praze (CUNI), Czech Republic; (9) Vereniging Samenwerkende Ouder-En Patientenorganisaties (VSOP), The Netherlands; (10) Ospedale Pediatrico Bambino Gesù (OPBG), Italy.