TINN

TINN

FLUCONAZOLE VS MICAFUNGIN IN NEONATES WITH SUSPECTED OR CULTURE PROVEN CANDIDIASIS: A RANDOMIZED PHARMACOKINETIC AND SAFETY STUDY

Financed by : European Commission

Program : HEALTH-2007-4.2-1 – Adapting off-patent medicines to the specific needs of pediatric populations

Grant Agreement ID: 223614

Role in the project: Collaborator

Duration: November 2008 to October 2015

ABSTRACT

“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.”

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