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Treat Infections in NeoNates 2 - Evaluation of an infective agent (azithromycin) for the treatment of infections in preterm and term neonates

Objective

The aim of TINN2 is to evaluate azithromycin, included in the EMEA priority list of the therapeutic areas that need specific drug evaluation in preterm and term neonates. Azithromycin is a macrolid antibiotic with anti-inflammatory properties active against Ureaplasma. It might be effective in reducing the severity of bronhopulmonary disease in which Ureaplasma infection and inflammation play a role. TINN2 involves European leaders in neonatology, paediatric pharmacology, methodology and SMEs that will establish links with ethical bodies and regulatory authorities. The programme will perform in silico experiments and evaluate formulations for neonates. The randomized placebo-controlled trial will be optimized using age-appropriate state-of-the-art methods adapted to neonates (including in silico experiments, pharmacokinetics and pharmacogenetics) to validate the components of a Paediatric Investigation Plan. It will be performed by neonatologists trained in paediatric pharmacology and clinical research in line with guidelines on Good Clinical Practice. All the ethical issues will be considered, including pain and distress, blood sampling (number and volume) and informed consent. Parent information sheets and consent form will be submitted to parents’ associations for approval. TINN2 will include short term safety and potential for long term adverse reactions. Results will be reported in order to allow a PUMA application and to improve neonatal care. Therefore, TINN2 will validate the appropriate use of azithromycin in neonates which will be of direct benefit to children, their families and health professionals. TINN2 will strengthen paediatric drug evaluation across Europe, support recent initiatives from the European pharmaceutical industry and build up a network of units with experience in clinical research that will be used for additional drug evaluation in neonates.

Call for proposal

FP7-HEALTH-2010-single-stage
See other projects for this call

Funding Scheme

CP-FP - Small or medium-scale focused research project

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
€ 780 000
Administrative Contact
Isabelle Pires (Ms.)

Participants (15)

INSERM TRANSFERT SA
France
EU contribution
€ 310 000
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 LIVERPOOL
United Kingdom
EU contribution
€ 547 000
Address
Brownlow Hill 765 Foundation Building
L69 7ZX Liverpool
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Suzanne Halpin (Ms.)
CARDIFF UNIVERSITY
United Kingdom
EU contribution
€ 852 000
Address
Newport Road 30-36
CF24 ODE Cardiff
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Nick Bodycombe (Mr.)
THE UNIVERSITY OF NOTTINGHAM
United Kingdom
EU contribution
€ 149 000
Address
University Park
NG7 2RD Nottingham
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Paul Cartledge (Mr.)
ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM
Netherlands
EU contribution
€ 223 000
Address
Dr Molewaterplein 40
3015 GD Rotterdam
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Geert Smid (Dr.)
HEINRICH-HEINE-UNIVERSITAET DUESSELDORF
Germany
EU contribution
€ 25 000
Address
Universitaetsstrasse 1
40225 Dusseldorf
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Patricia Nitsch (Ms.)
ASSISTANCE PUBLIQUE HOPITAUX DE PARIS
France
EU contribution
€ 402 000
Address
3 Avenue Victoria
75000 Paris
Activity type
Research Organisations
Administrative Contact
Emmanuel Quissac (Mr.)
ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI
Italy
EU contribution
€ 252 000
Address
Via Mario Negri 2
20156 Milano
Activity type
Research Organisations
Administrative Contact
Maria Grazia Pezzoni (Ms.)
ADVANCED BIOLOGICAL LABORATORIES S.A.
Luxembourg
EU contribution
€ 200 000
Address
Avenue X Septembre 52-54
L-2250 Luxembourg
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Chalom Sayada (Mr.)
CERTARA UK LIMITED
United Kingdom
EU contribution
€ 50 000
Address
One London Wall 6Th Floor
EC2Y 5EB London
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
John Evans (Mr.)
Only For Children Pharmaceuticals
France
EU contribution
€ 485 000
Address
Rue Henri Barbusse 35 Bis
75005 Paris
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Vincent Grek (Dr.)
UNIVERSITAET ULM
Germany
EU contribution
€ 300 000
Address
Helmholtzstrasse 16
89081 Ulm
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Frank Gleixner (Mr.)
KAROLINSKA INSTITUTET
Sweden
EU contribution
€ 200 000
Address
Nobels Vag 5
17177 Stockholm
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Thomas Walstam (Mr.)
CENTRE HOSPITALIER CHRETIEN ASBL
Belgium
EU contribution
€ 25 000
Address
Rue De Hesbaye 75
4000 Liege
Activity type
Other
Administrative Contact
Dominique Masson (Ms.)
SEMMELWEIS EGYETEM
Hungary
EU contribution
€ 200 000
Address
Ulloi Utca 26
1085 Budapest
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Vilmos Ivady (Dr.)