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. Fields of science medical and health sciencesbasic medicinepharmacology and pharmacypharmacokineticsmedical and health sciencesclinical medicinepaediatrics Programme(s) FP7-HEALTH - Specific Programme "Cooperation": Health Topic(s) HEALTH.2010.4.2-1 - Off-Patent Medicines for Children. FP7-HEALTH-2010-single-stage 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 EU contribution € 780 000,00 Address RUE DE TOLBIAC 101 75654 Paris France See on map Region Ile-de-France Ile-de-France Paris Activity type Research Organisations Administrative Contact Isabelle Pires (Ms.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data Participants (15) Sort alphabetically Sort by EU Contribution Expand all Collapse all INSERM TRANSFERT SA France EU contribution € 310 000,00 Address 10 RUE D'ORADOUR-SUR-GLANE - PARISANTE CAMPUS 75015 PARIS See on map Region Ile-de-France Ile-de-France Paris Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Administrative Contact Louis Jammayrac (Mr.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data THE UNIVERSITY OF LIVERPOOL United Kingdom EU contribution € 547 000,00 Address BROWNLOW HILL 765 FOUNDATION BUILDING L69 7ZX Liverpool See on map Region North West (England) Merseyside Liverpool Activity type Higher or Secondary Education Establishments Administrative Contact Suzanne Halpin (Ms.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data CARDIFF UNIVERSITY United Kingdom EU contribution € 852 000,00 Address NEWPORT ROAD 30 36 CF24 0DE Cardiff See on map Region Wales East Wales Cardiff and Vale of Glamorgan Activity type Higher or Secondary Education Establishments Administrative Contact Nick Bodycombe (Mr.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data THE UNIVERSITY OF NOTTINGHAM United Kingdom EU contribution € 149 000,00 Address University Park NG7 2RD Nottingham See on map Region East Midlands (England) Derbyshire and Nottinghamshire Nottingham Activity type Higher or Secondary Education Establishments Administrative Contact Paul Cartledge (Mr.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM Netherlands EU contribution € 223 000,00 Address DR MOLEWATERPLEIN 40 3015 GD Rotterdam See on map Region West-Nederland Zuid-Holland Groot-Rijnmond Activity type Higher or Secondary Education Establishments Administrative Contact Geert Smid (Dr.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data HEINRICH-HEINE-UNIVERSITAET DUESSELDORF Germany EU contribution € 25 000,00 Address UNIVERSITAETSSTRASSE 1 40225 Dusseldorf See on map Region Nordrhein-Westfalen Düsseldorf Düsseldorf, Kreisfreie Stadt Activity type Higher or Secondary Education Establishments Administrative Contact Patricia Nitsch (Ms.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data ASSISTANCE PUBLIQUE HOPITAUX DE PARIS France EU contribution € 402 000,00 Address 55 BOULEVARD DIDEROT 75012 Paris See on map Region Ile-de-France Ile-de-France Val-de-Marne Activity type Research Organisations Administrative Contact Emmanuel Quissac (Mr.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI Italy EU contribution € 252 000,00 Address VIA MARIO NEGRI 2 20156 Milano See on map Region Nord-Ovest Lombardia Milano Activity type Research Organisations Administrative Contact Maria Grazia Pezzoni (Ms.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data ADVANCED BIOLOGICAL LABORATORIES S.A. Luxembourg EU contribution € 200 000,00 Address AVENUE X SEPTEMBRE 52-54 L-2250 LUXEMBOURG See on map Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Administrative Contact Chalom Sayada (Mr.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data CERTARA UK LIMITED United Kingdom EU contribution € 50 000,00 Address ONE LONDON WALL 6TH FLOOR EC2Y 5EB London See on map Region London Inner London — West Camden and City of London Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Administrative Contact John Evans (Mr.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data Only For Children Pharmaceuticals France EU contribution € 485 000,00 Address Rue Henri Barbusse 35 bis 75005 Paris See on map Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Administrative Contact Vincent Grek (Dr.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data UNIVERSITAET ULM Germany EU contribution € 300 000,00 Address HELMHOLTZSTRASSE 16 89081 Ulm See on map Region Baden-Württemberg Tübingen Ulm, Stadtkreis Activity type Higher or Secondary Education Establishments Administrative Contact Frank Gleixner (Mr.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data KAROLINSKA INSTITUTET Sweden EU contribution € 200 000,00 Address Nobels Vag 5 17177 Stockholm See on map Region Östra Sverige Stockholm Stockholms län Activity type Higher or Secondary Education Establishments Administrative Contact Thomas Walstam (Mr.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data CENTRE HOSPITALIER CHRETIEN ASBL Belgium EU contribution € 25 000,00 Address RUE DE HESBAYE 75 4000 LIEGE See on map Activity type Other Administrative Contact Dominique Masson (Ms.) Links Contact the organisation Opens in new window Total cost No data SEMMELWEIS EGYETEM Hungary EU contribution € 200 000,00 Address ULLOI UTCA 26 1085 Budapest See on map Region Közép-Magyarország Budapest Budapest Activity type Higher or Secondary Education Establishments Administrative Contact Vilmos Ivady (Dr.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data
