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Evaluation of antibiotics (ciprofloxacin and fluconazole) for the treatment of infections in preterm and term neonates

Objective

The aim of TINN is to evaluate ciprofloxacin, fluconazole and micafungin in neonates; two anti-infectious drugs included in the EMEA priority list of the therapeutic areas that need specific drug evaluation in preterm and term neonates. These drugs are prescribed off-label to treat neonatal infections that are life threatening situations and associated with long-term complications. In order to validate the use of these two drugs in these high risk populations, TINN involves European leaders in neonatology, paediatric pharmacology, methodology and SME and has established a close collaboration between academia, ethical bodies, regulatory authorities and pharmaceutical companies. For both drugs, the project will perform in silico experimentations, animal studies and evaluate formulations adapted to neonates. Designs will be optimized using age-appropriate state-of-the-art methods adapted to neonates, include pharmacokinetics and pharmacogenetics in order to validate the components of a Paediatric Investigation Plan. The two trials will be performed with neonatologists trained in paediatric pharmacology and clinical research who respect Good Clinical Practices. All the ethical issues related to the two trials will be considered in particular pain and distress, blood sampling (number and volume) and informed consent. Parent information sheets and consent form submitted to parents’ associations for approval. TINN will include short-term safety (based on vital signs, blood safety data and function of the major
organs) and potential for long-term adverse reactions. Results will be also reported in order to allow a PUMA application and to improve neonatal care, through scientific societies. Therefore, TINN will strengthen the European role in drug evaluation in paediatric patients and will support initiatives of the European pharmaceutical industry. Increasing the appropriate use of medicines in child will be of direct benefit to children, their families and health professionals.

Call for proposal

FP7-HEALTH-2007-B
See other projects for this call

Coordinator

INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE
Address
Rue De Tolbiac 101
75654 Paris
France
Activity type
Research Organisations
EU contribution
€ 1 277 401
Administrative Contact
Isabelle Pires (Ms.)

Participants (15)

INSERM TRANSFERT SA
France
EU contribution
€ 470 072
Address
Rue Watt 7
75013 Paris
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Louis Jammayrac (Mr.)
THE UNIVERSITY OF NOTTINGHAM
United Kingdom
EU contribution
€ 300 000
Address
University Park
NG7 2RD Nottingham
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Paul Carthedge (Mr.)
UNIVERSITE LYON 1 CLAUDE BERNARD
France
EU contribution
€ 215 232
Address
Boulevard Du 11 Novembre 1918 Num43
69622 Villeurbanne Cedex
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Javier Olaiz (Mr.)
AZIENDA OSPEDALIERA, OSPEDALE INFANTILE REGINA MARGHERITA-SANT' ANNA DI TORINO
Italy
EU contribution
€ 459 991
Address
Corso Spezia 60
10126 Torino
Activity type
Research Organisations
Administrative Contact
Osvaldo D'angella
THE UNIVERSITY OF LIVERPOOL
United Kingdom
EU contribution
€ 569 882
Address
Brownlow Hill 765 Foundation Building
L69 7ZX Liverpool
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Veronica Shaw (Ms.)
ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM
Netherlands
EU contribution
€ 212 069
Address
Dr Molewaterplein 40
3015 GD Rotterdam
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Annemieke Steenbergen (Dr.)
UNIVERSITAET ULM
Germany
EU contribution
€ 100 000
Address
Helmholtzstrasse 16
89081 Ulm
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Frank Gleixner
CENTRE HOSPITALIER CHRETIEN ASBL
Belgium
EU contribution
€ 157 403
Address
Rue De Hesbaye 75
4000 Liege
Activity type
Other
Administrative Contact
Dominique Masson (Ms.)
UNIVERSITEIT ANTWERPEN

Participation ended

Belgium
Address
Prinsstraat 13
2000 Antwerpen
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Bart Van Overmeire (Prof.)
UNIVERSITE DE TOURS
France
EU contribution
€ 109 632
Address
Rue Du Plat D Etain 60
37020 Tours
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Francis-Florent Gauthier (Mr.)
ASSISTANCE PUBLIQUE HOPITAUX DE PARIS
France
EU contribution
€ 705 527
Address
3 Avenue Victoria
75000 Paris
Activity type
Research Organisations
Administrative Contact
Emmanuel Quissac (Mr.)
CLININFO SA
France
EU contribution
€ 190 000
Address
Rue De Gerland 99 Entree 7
69007 Lyon
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Patrick Chevarier (Mr.)
EUROPEAN PAEDIATRIC MEDICINE COMPANY
Belgium
EU contribution
€ 58 600
Address
Dreve Sainte-anne 68B
1020 Bruxelles
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Jacques De Waele (Mr.)
ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI
Italy
EU contribution
€ 185 509
Address
Via Mario Negri 2
20156 Milano
Activity type
Research Organisations
Administrative Contact
Maria Grazia Pezzoni (Ms.)
KAROLINSKA INSTITUTET
Sweden
EU contribution
€ 149 682
Address
Nobels Vag 5
17177 Stockholm
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Kim Von Schoultz (Mr.)