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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.

Call for proposal

FP7-HEALTH-2013-INNOVATION-1
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Coordinator

UNIVERSITATSKLINIKUM ERLANGEN
Address
Maximiliansplatz 2
91054 Erlangen
Germany

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Katrin Faber (Dr.)
EU contribution
€ 1 803 610,55

Participants (11)

UNIVERSITY COLLEGE LONDON
United Kingdom
EU contribution
€ 587 368,20
Address
Gower Street
WC1E 6BT London

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Kamila Kolasinska (Ms.)
Therakind Ltd
United Kingdom
EU contribution
€ 1 917 800
Address
Dollis Park Road Winston House 2
NE 1HF London

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Louise Rawcliffe (Ms.)
ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM
Netherlands
EU contribution
€ 421 600
Address
Dr Molewaterplein 40
3015 GD Rotterdam

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Ellen Schenk (Mrs.)
FONDAZIONE PER LA RICERCA FARMACOLOGICA GIANNI BENZI ONLUS
Italy
EU contribution
€ 403 560
Address
Via Abate Eustasio 30
70010 Valenzano Bari

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Activity type
Research Organisations
Administrative Contact
Fedele Bonifazi (Mr.)
KAROLINSKA INSTITUTET
Sweden
EU contribution
€ 255 700
Address
Nobels Vag 5
17177 Stockholm

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Eva Gipperth (Mrs.)
TARTU ULIKOOL
Estonia
EU contribution
€ 259 725
Address
Ulikooli 18
51005 Tartu

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Tuuli Metsvaht (Dr.)
UNIVERZITA KARLOVA
Czechia
EU contribution
€ 88 750
Address
Ovocny Trh 560/5
116 36 Praha 1

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Kristyna Matejkova (Ms.)
VERENIGING SAMENWERKENDE OUDER- EN PATIENTENORGANISATIES
Netherlands
EU contribution
€ 108 000
Address
Vredehofstraat 31
3761HA Soest

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Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
Cor Oosterwijk (Dr.)
OSPEDALE PEDIATRICO BAMBINO GESU
Italy
EU contribution
€ 81 991
Address
Piazza Sant Onofrio 4
00165 Roma

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Activity type
Research Organisations
Administrative Contact
Sonya Jane Martin (Dr.)
SERVICIO MADRILENO DE SALUD
Spain
EU contribution
€ 39 600
Address
Plaza Carlos Trias Bertran 7
28020 Madrid

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Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
Mar López (Ms.)
AZIENDA DI RILIEVO NAZIONALE E DI ALTA SPECIALIZZAZIONE
Italy
EU contribution
€ 29 700
Address
Piazza Nicola Leotta 4
90127 Palermo

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Activity type
Research Organisations
Administrative Contact
Vincenzo Barone (Dr.)