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Clonidine for Sedation of Paediatric Patients in the Intensive Care Unit

Objective

The majority of critically ill children admitted to Paediatric Intensive Care Units (PICU) will require sedation and analgesia which is commonly achieved with a combination of an benzodiazepine and an opioid. However, these agents have a significant side-effect profile, including tolerance, withdrawal and respiratory/circulatory depression. Clonidine is commonly used for sedation in PICU and recommended by guidelines in various countries although there is a lack of evidence regarding it safety and efficacy in this setting. The need for safety and efficacy data as well as an age appropriate formulation for clonidine has been realised and clonidine is included in the EMA “Revised Priority List for Studies into Off-patent Medicinal Products”. Thus this proposal addresses an important paediatric therapeutic need. It is designed to fullfill the requirements for most ethical research in the paediatric population considering risk minimisation for patients, avoiding unnecessary studies and make use of already available data as outlined in the Paediatric Regulation (EC) No 1901/2006. The objectives of this project are a) to develop an age appropriate formulation of clonidine suitable for sedation of children in PICU b) to conduct a randomised, phase III, double-blind, active-controlled parallel group clinical trial of clonidine vs midazolam in patients from birth to 18 years to establish the efficacy and safety, including long-term outcomes and dose-dependent effects of clonidine and c) to establish an European consensus guideline for sedion of critically ill children. The ultimate goal is to use these data and to apply for a PUMA. On this basis a Paediatric Investigation Plan (PIP) has been approved by the EMA in February 2013 and is reflected in the work plan of CloSed. The project will increase the availability of paediatric medicines, foster the conduct of clinical trials in children and establish international paediatric research collaborations.
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Coordinator

UNIVERSITATSKLINIKUM ERLANGEN

Address

Maximiliansplatz 2
91054 Erlangen

Germany

Activity type

Higher or Secondary Education Establishments

EU Contribution

€ 1 428 894,80

Administrative Contact

Katrin Faber (Dr.)

Participants (9)

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UNIVERSITY COLLEGE LONDON

United Kingdom

EU Contribution

€ 587 368,20

Therakind Ltd

United Kingdom

EU Contribution

€ 1 917 800

ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM

Netherlands

EU Contribution

€ 776 600

FONDAZIONE PER LA RICERCA FARMACOLOGICA GIANNI BENZI ONLUS

Italy

EU Contribution

€ 352 340

KAROLINSKA INSTITUTET

Sweden

EU Contribution

€ 381 700

TARTU ULIKOOL

Estonia

EU Contribution

€ 180 975

UNIVERZITA KARLOVA

Czechia

EU Contribution

€ 166 750

VERENIGING SAMENWERKENDE OUDER- EN PATIENTENORGANISATIES

Netherlands

EU Contribution

€ 108 000

OSPEDALE PEDIATRICO BAMBINO GESU

Italy

EU Contribution

€ 96 976,75

Project information

Grant agreement ID: 602453

Status

Closed project

  • Start date

    1 December 2013

  • End date

    30 November 2018

Funded under:

FP7-HEALTH

  • Overall budget:

    € 7 386 671,74

  • EU contribution

    € 5 997 404,75

Coordinated by:

UNIVERSITATSKLINIKUM ERLANGEN

Germany