TINN2

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

 Coordinatore INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM) 

 Organization address address: 101 Rue de Tolbiac
city: PARIS
postcode: 75654

contact info
Titolo: Ms.
Nome: Isabelle
Cognome: Pires
Email: send email
Telefono: +33 1 43 62 27 16
Fax: +33 1 43 62 27 01

 Nazionalità Coordinatore France [FR]
 Totale costo 6˙540˙008 €
 EC contributo 5˙000˙000 €
 Programma FP7-HEALTH
Specific Programme "Cooperation": Health
 Code Call FP7-HEALTH-2010-single-stage
 Funding Scheme CP-FP
 Anno di inizio 2011
 Periodo (anno-mese-giorno) 2011-01-01   -   2015-12-31

 Partecipanti

# participant  country  role  EC contrib. [€] 
1    INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)

 Organization address address: 101 Rue de Tolbiac
city: PARIS
postcode: 75654

contact info
Titolo: Ms.
Nome: Isabelle
Cognome: Pires
Email: send email
Telefono: +33 1 43 62 27 16
Fax: +33 1 43 62 27 01

FR (PARIS) coordinator 780˙000.00
2    CARDIFF UNIVERSITY

 Organization address address: Newport Road 30-36
city: CARDIFF
postcode: CF24 ODE

contact info
Titolo: Mr.
Nome: Nick
Cognome: Bodycombe
Email: send email
Telefono: +44 29 2087 0171
Fax: +44 29 2087 4189

UK (CARDIFF) participant 852˙000.00
3    THE UNIVERSITY OF LIVERPOOL

 Organization address address: Brownlow Hill, Foundation Building 765
city: LIVERPOOL
postcode: L69 7ZX

contact info
Titolo: Ms.
Nome: Suzanne
Cognome: Halpin
Email: send email
Telefono: +44 151 794 8725
Fax: +44 151 794 8728

UK (LIVERPOOL) participant 547˙000.00
4    Only For Children Pharmaceuticals

 Organization address address: Rue Henri Barbusse 35 bis
city: Paris
postcode: 75005

contact info
Titolo: Dr.
Nome: Vincent
Cognome: Grek
Email: send email
Telefono: +33 1 57278686
Fax: +33 1 57278689

FR (Paris) participant 485˙000.00
5    ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS

 Organization address address: 3 Avenue Victoria
city: PARIS
postcode: 75004

contact info
Titolo: Mr.
Nome: Emmanuel
Cognome: Quissac
Email: send email
Telefono: +33 140031089
Fax: +33 140032498

FR (PARIS) participant 402˙000.00
6    INSERM - TRANSFERT SA

 Organization address address: Rue Watt 7
city: PARIS
postcode: 75013

contact info
Titolo: Mr.
Nome: Louis
Cognome: Jammayrac
Email: send email
Telefono: +33 1 55 03 01 01
Fax: +33 1 55 03 01 60

FR (PARIS) participant 310˙000.00
7    UNIVERSITAET ULM

 Organization address address: HELMHOLTZSTRASSE 16
city: ULM
postcode: 89081

contact info
Titolo: Mr.
Nome: Frank
Cognome: Gleixner
Email: send email
Telefono: +49 731 500 66397
Fax: +49 731 500 66392

DE (ULM) participant 300˙000.00
8    ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI

 Organization address address: Via Giuseppe La Masa 19
city: MILANO
postcode: 20156

contact info
Titolo: Ms.
Nome: Maria Grazia
Cognome: Pezzoni
Email: send email
Telefono: +39 02 39014511
Fax: +39 02 3550924

IT (MILANO) participant 252˙000.00
9    ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM

 Organization address address: 's Gravendijkwal 230
city: ROTTERDAM
postcode: 3015CE

contact info
Titolo: Dr.
Nome: Geert
Cognome: Smid
Email: send email
Telefono: +31 10 7036 945
Fax: +31 10 4636288

NL (ROTTERDAM) participant 223˙000.00
10    ADVANCED BIOLOGICAL LABORATORIES S.A.

 Organization address address: AVENUE X SEPTEMBRE 52-54
city: LUXEMBOURG
postcode: L-2250

contact info
Titolo: Mr.
Nome: Chalom
Cognome: Sayada
Email: send email
Telefono: +35 2 2638 8921
Fax: +35 2 2638 8938

LU (LUXEMBOURG) participant 200˙000.00
11    KAROLINSKA INSTITUTET

 Organization address address: Nobels Vag 5
city: STOCKHOLM
postcode: 17177

contact info
Titolo: Mr.
Nome: Thomas
Cognome: Walstam
Email: send email
Telefono: +468524 88400
Fax: +468517 71774

SE (STOCKHOLM) participant 200˙000.00
12    SEMMELWEIS EGYETEM

 Organization address address: Ulloi ut 26
city: BUDAPEST
postcode: 1085

contact info
Titolo: Dr.
Nome: Vilmos
Cognome: Ivady
Email: send email
Telefono: +36 1 2660454
Fax: +36 1 2660454

HU (BUDAPEST) participant 200˙000.00
13    THE UNIVERSITY OF NOTTINGHAM

 Organization address address: University Park
city: NOTTINGHAM
postcode: NG7 2RD

contact info
Titolo: Mr.
Nome: Paul
Cognome: Cartledge
Email: send email
Telefono: +44 115 95 15 679
Fax: +44 115 95 13 633

UK (NOTTINGHAM) participant 149˙000.00
14    SIMCYP LIMITED

 Organization address address: LEAVYGREAVE ROAD 40
city: SHEFFIELD
postcode: S3 7RD

contact info
Titolo: Mr.
Nome: John
Cognome: Evans
Email: send email
Telefono: +44 1 14 292 2322
Fax: +44 1 142922333

UK (SHEFFIELD) participant 50˙000.00
15    CENTRE HOSPITALIER CHRETIEN ASBL

 Organization address address: RUE DE HESBAYE 75
city: LIEGE
postcode: 4000

contact info
Titolo: Ms.
Nome: Dominique
Cognome: Masson
Email: send email
Telefono: +32 4 224 80 31
Fax: +32 4 224 80 31

BE (LIEGE) participant 25˙000.00
16    HEINRICH-HEINE-UNIVERSITAET DUESSELDORF

 Organization address address: UNIVERSITAETSSTRASSE 1
city: DUSSELDORF
postcode: 40225

contact info
Titolo: Ms.
Nome: Patricia
Cognome: Nitsch
Email: send email
Telefono: +49 2118111398
Fax: +49 211812422

DE (DUSSELDORF) participant 25˙000.00

Mappa


 Word cloud

Esplora la "nuvola delle parole (Word Cloud) per avere un'idea di massima del progetto.

group    experiments    pharmacology    methodology    medicines    preterm    paediatric    ciprofloxacin    fluconazole    trials    plan    perform    safety    validate    appropriate    prescribed    silico    tinn    antibiotics    children    drug    ureaplasma    consent    formulations    adults    drugs    azithromycin    young    dosing    performed    clinical    evaluation    adverse    ethical    neonates    investigation    age   

 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.

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