CLOSED

Clonidine for Sedation of Paediatric Patients in the Intensive Care Unit

 Coordinatore UNIVERSITATSKLINIKUM ERLANGEN 

 Organization address address: Maximiliansplatz 2
city: ERLANGEN
postcode: 91054

contact info
Titolo: Dr.
Nome: Katrin
Cognome: Faber
Email: send email
Telefono: +49 9131 8535902
Fax: +49 9131 8535903

 Nazionalità Coordinatore Germany [DE]
 Totale costo 7˙378˙566 €
 EC contributo 5˙997˙404 €
 Programma FP7-HEALTH
Specific Programme "Cooperation": Health
 Code Call FP7-HEALTH-2013-INNOVATION-1
 Funding Scheme CP-FP
 Anno di inizio 2013
 Periodo (anno-mese-giorno) 2013-12-01   -   2018-11-30

 Partecipanti

# participant  country  role  EC contrib. [€] 
1    UNIVERSITATSKLINIKUM ERLANGEN

 Organization address address: Maximiliansplatz 2
city: ERLANGEN
postcode: 91054

contact info
Titolo: Dr.
Nome: Katrin
Cognome: Faber
Email: send email
Telefono: +49 9131 8535902
Fax: +49 9131 8535903

DE (ERLANGEN) coordinator 1˙360˙060.00
2    Therakind Ltd

 Organization address address: DOLLIS PARK ROAD WINSTON HOUSE 2
city: London
postcode: NE 1HF

contact info
Titolo: Ms.
Nome: Louise
Cognome: Rawcliffe
Email: send email
Telefono: +44 20 8346 6035

UK (London) participant 1˙917˙800.00
3    ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM

 Organization address address: 's Gravendijkwal 230
city: ROTTERDAM
postcode: 3015CE

contact info
Titolo: Mrs.
Nome: Ellen
Cognome: Schenk
Email: send email
Telefono: 31107044876

NL (ROTTERDAM) participant 788˙600.00
4    UNIVERSITY COLLEGE LONDON

 Organization address address: GOWER STREET
city: LONDON
postcode: WC1E 6BT

contact info
Titolo: Ms.
Nome: Kamila
Cognome: Kolasinska
Email: send email
Telefono: +44 20 31083033
Fax: +44 20 31083096

UK (LONDON) participant 592˙993.00
5    KAROLINSKA INSTITUTET

 Organization address address: Nobels Vag 5
city: STOCKHOLM
postcode: 17177

contact info
Titolo: Mrs.
Nome: Eva
Cognome: Gipperth
Email: send email
Telefono: +46 852487199
Fax: +46 8304613

SE (STOCKHOLM) participant 393˙700.00
6    FONDAZIONE PER LA RICERCA FARMACOLOGICA GIANNI BENZI ONLUS

 Organization address address: VIA ABATE EUSTASIO 30
city: VALENZANO BARI
postcode: 70010

contact info
Titolo: Mr.
Nome: Fedele
Cognome: Bonifazi
Email: send email
Telefono: +39 080 4670430
Fax: +39 080 4670281

IT (VALENZANO BARI) participant 374˙840.00
7    UNIVERZITA KARLOVA V PRAZE

 Organization address address: Ovocny trh 5
city: PRAHA 1
postcode: 11636

contact info
Titolo: Ms.
Nome: Kristyna
Cognome: Matejkova
Email: send email
Telefono: +420 224964264
Fax: +420 224964163

CZ (PRAHA 1) participant 178˙750.00
8    TARTU ULIKOOL

 Organization address address: ULIKOOLI 18
city: TARTU
postcode: 50090

contact info
Titolo: Dr.
Nome: Tuuli
Cognome: Metsvaht
Email: send email
Telefono: +372 7319550
Fax: +372 7319503

EE (TARTU) participant 175˙350.00
9    VERENIGING SAMENWERKENDE OUDER- EN PATIENTENORGANISATIES

 Organization address address: Vredehofstraat 31
city: SOEST
postcode: 3761HA

contact info
Titolo: Dr.
Nome: Cor
Cognome: Oosterwijk
Email: send email
Telefono: +31 356034040

NL (SOEST) participant 108˙000.00
10    OSPEDALE PEDIATRICO BAMBINO GESU

 Organization address address: PIAZZA SAN ONOFRIO 4
city: ROMA
postcode: 165

contact info
Titolo: Dr.
Nome: Sonya Jane
Cognome: Martin
Email: send email
Telefono: +39 06 6859 2497
Fax: +39 06 6859 2101

IT (ROMA) participant 107˙311.75

Mappa


 Word cloud

Esplora la "nuvola delle parole (Word Cloud) per avere un'idea di massima del progetto.

plan    children    critically    clonidine    patients    data    paediatric    sedation    picu    clinical    ill    efficacy    age    safety    formulation    appropriate    conduct    ema   

 Obiettivo del progetto (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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