The new European project CloSed (Clonidine for Sedation of Paediatric Patients in the Intensive Care Unit, 602453-FP7-HEALTH-2013-INNOVATION-1), funded in the framework of the 7th FP, was officially kicked off in Erlangen (Germany) on December 2nd – 3rd 2013. The Kick-off Meeting was organised by the University Hospital of Erlangen (UKER) and was attended by 10 European partners, including two Italian Istitutions (Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus and Ospedale Pediatrico Bambino Gesù).
The project will last five years and is aimed to develop an age appropriate, GMP manufactured clonidine formulation and to test it in an efficacy and safety randomised phase III double-blind, active-controlled clinical trial involving children from birth to 18 years. Clonidine is a drug already used for sedation in Paediatric Intensive Care Units (PICU) and recommended by guidelines in various countries, although the lack of evidence regarding its safety and efficacy in this setting.
The majority of critically ill children admitted to Paediatric Intensive Care Units (PICU) will require, in fact, sedation and analgesia which are commonly achieved with drugs having a significant side-effect profile.
CloSed will not simply generate new clinical trial data, but following the results of clinical trials, an application for a Paediatric Use Marketing Authorisation (PUMA) will be submitted and the drug will be available for the use in paediatrics all around Europe.
During the Kick-off Meeting, the organisation of the planned studies and the ethical and administrative issues were deeply discussed. An overview of the EU project requirements was also presented by the European Officer, Dr. C. Oikonomidis.
The partnership of the project also includes a company, Therakind, responsible of all the regulatory activities related to the clinical trial and of the submission of the application for a Paediatric Use Marketing Authorisation (PUMA). The Gianni Benzi Pharmacological Research Foundation is one of the partners and will have a central role in regulatory, ethical, training and dissemination activities and will also contribute to the project management.