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

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

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.

Coordinator

INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE

Address

Rue De Tolbiac 101
75654 Paris

France

Activity type

Higher or Secondary Education Establishments

EU Contribution

€ 780 000

Administrative Contact

Isabelle Pires (Ms.)

Participants (15)

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INSERM TRANSFERT SA

France

EU Contribution

€ 310 000

THE UNIVERSITY OF LIVERPOOL

United Kingdom

EU Contribution

€ 547 000

CARDIFF UNIVERSITY

United Kingdom

EU Contribution

€ 852 000

THE UNIVERSITY OF NOTTINGHAM

United Kingdom

EU Contribution

€ 149 000

ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM

Netherlands

EU Contribution

€ 223 000

HEINRICH-HEINE-UNIVERSITAET DUESSELDORF

Germany

EU Contribution

€ 25 000

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS

France

EU Contribution

€ 402 000

ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI

Italy

EU Contribution

€ 252 000

ADVANCED BIOLOGICAL LABORATORIES S.A.

Luxembourg

EU Contribution

€ 200 000

CERTARA UK LIMITED

United Kingdom

EU Contribution

€ 50 000

Only For Children Pharmaceuticals

France

EU Contribution

€ 485 000

UNIVERSITAET ULM

Germany

EU Contribution

€ 300 000

KAROLINSKA INSTITUTET

Sweden

EU Contribution

€ 200 000

CENTRE HOSPITALIER CHRETIEN ASBL

Belgium

EU Contribution

€ 25 000

SEMMELWEIS EGYETEM

Hungary

EU Contribution

€ 200 000

Project information

Grant agreement ID: 260908

Status

Closed project

  • Start date

    1 January 2011

  • End date

    31 December 2015

Funded under:

FP7-HEALTH

  • Overall budget:

    € 6 540 008,80

  • EU contribution

    € 5 000 000

Coordinated by:

INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE

France