TINN

Evaluation of antibiotics (ciprofloxacin and fluconazole) for the treatment of infections in preterm and term neonates

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 Obiettivo del progetto (Objective)

'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.'

Introduzione (Teaser)

Newborn babies can sometimes face life-threatening infectious diseases at birth. An EU-funded project is evaluating two antimicrobial drugs for use in neonates.

Descrizione progetto (Article)

Neonates (newborns) suffering from sepsis (a severe response to bacteria or other microbes) or the fungal infection candidiasis can become seriously ill and, in extreme cases, die.

Babies with life-threatening strains of these afflictions are often treated with ciprofloxacin and fluconazole, two anti-infective drugs prescribed 'off-label' to treat serious neonatal infections. Both drugs are included in the European Medicines Agency (EMA) priority list of therapeutic areas requiring specific drug evaluation in pre-term and term neonates.

To make it easier for babies to be administered these drugs in serious cases where they can be life-saving, the EU-funded TINN project was set up. The TINN team will conduct clinical trials to evaluate the efficacy and safety of ciprofloxacin and fluconazole. Another objective is to develop formulations adapted to pre-term and term neonates, in order to apply for a Paediatric Use Marketing Authorisation (PUMA).

TINN has been established with the help of European leaders in neonatology, paediatric pharmacology, methodology and pharmaceuticals, under the guidance of ethical bodies and regulatory authorities. The project team has pursued a programme of computer-simulated experimentations and animal studies to evaluate formulations that can be used safely in very young babies.

Neonatologists trained in paediatric pharmacology and clinical research have performed trials using age-appropriate, state-of-the-art methods to validate the components of a paediatric investigation plan (PIP). At this stage, paediatric investigation plans for both ciprofloxacin and fluconazole have been submitted to the EMA and are under discussion.

After examination by the ethics committee and regulatory agreements, the pilot study for ciprofloxacin started in France and in the United Kingdom early in 2012. It included 30 babies. The pilot study for fluconazole began in the second half of 2012.

Literature reviews for both drugs have been performed and published in peer-reviewed journals. The dissemination of results will be ongoing through a series of meetings with scientific societies and presentations.

TINN aims to improve neonatal care via the approval of these two drugs and create a network of units experienced in evaluating anti-infective agents in neonates.