Cel
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.
Dziedzina nauki
Zaproszenie do składania wniosków
FP7-HEALTH-2010-single-stage
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System finansowania
CP-FP - Small or medium-scale focused research projectKoordynator
75654 Paris
Francja
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Uczestnicy (15)
75015 PARIS
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L69 7ZX Liverpool
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CF24 0DE Cardiff
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NG7 2RD Nottingham
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3015 GD Rotterdam
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40225 Dusseldorf
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75012 Paris
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20156 Milano
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L-2250 LUXEMBOURG
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EC2Y 5EB London
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75005 Paris
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89081 Ulm
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17177 Stockholm
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4000 LIEGE
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1085 Budapest
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