TINN2

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

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 Obiettivo del progetto (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.'

Introduzione (Teaser)

Approximately half of the medicines prescribed to children in hospitals are either unlicensed for their age group or, if licensed, are prescribed off label. The TINN and TINN2 projects are evaluating the use of two antibiotics (Azithromycin and Ciprofloxacin) and one antifungal drug (Fluconazole) for newborns and young children.

Descrizione progetto (Article)

Pharmacology, methodology and dosing are vastly different between adults and children. In order to optimise medical treatment of young children, especially the vulnerable group of preterm and term neonates, the TINN projects study dosing regimens of the three drugs frequently prescribed to children.

The TINN2 project summarised the results of the azithromycin paediatric clinical trials performed both inside and outside the European Union. This study is particularly important for drugs already available on the market for adults, but not covered by a patent. Since adult clinical trials cannot adequately detect possible adverse effects on child development, paediatric clinical trials are warranted.

This study resulted in the preparation and submission of a Paediatric Investigation Plan (PIP) to the European Medicines Agency (EMA). This is an important achievement since it paves the way for other neonate-directed clinical trials involving new antibiotics, such as Ciprofloxacin and Fluconazole. Additionally, the programme will perform in silico experiments and evaluate the utility and safety of the new drug formulations adapted for neonates.