NEOMERO

"European multicenter network to evaluate pharmacokinetics, safety and efficacy of Meropenem in neonatal sepsis and meningitis"

 Coordinatore FONDAZIONE PENTA-FOR THE TREATMENT AND CARE OF CHILDREN WITH HIV-ONLUS 

 Organization address address: CORSO STATI UNITI 4
city: PADOVA
postcode: 35127

contact info
Titolo: Dr.
Nome: Silvia
Cognome: Faggion
Email: send email
Telefono: 390498000000
Fax: 390500000000

 Nazionalità Coordinatore Italy [IT]
 Totale costo 7˙672˙901 €
 EC contributo 5˙900˙000 €
 Programma FP7-HEALTH
Specific Programme "Cooperation": Health
 Code Call FP7-HEALTH-2009-single-stage
 Funding Scheme CP-FP
 Anno di inizio 2010
 Periodo (anno-mese-giorno) 2010-01-01   -   2015-06-30

 Partecipanti

# participant  country  role  EC contrib. [€] 
1    FONDAZIONE PENTA-FOR THE TREATMENT AND CARE OF CHILDREN WITH HIV-ONLUS

 Organization address address: CORSO STATI UNITI 4
city: PADOVA
postcode: 35127

contact info
Titolo: Dr.
Nome: Silvia
Cognome: Faggion
Email: send email
Telefono: 390498000000
Fax: 390500000000

IT (PADOVA) coordinator 1˙963˙921.00
2    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: Dr.
Nome: Jean-Pierre
Cognome: Aboulker
Email: send email
Telefono: 33145595107
Fax: 33145595180

FR (PARIS) participant 635˙204.00
3    TARTU ULIKOOL

 Organization address address: ULIKOOLI 18
city: TARTU
postcode: 50090

contact info
Titolo: Prof.
Nome: Irja
Cognome: Lutsar
Email: send email
Telefono: 3727374171
Fax: 3727374172

EE (TARTU) participant 541˙120.00
4    ST GEORGE'S HOSPITAL MEDICAL SCHOOL

 Organization address address: Cranmer Terrace
city: LONDON
postcode: SW17 0RE

contact info
Titolo: Dr.
Nome: Paul
Cognome: Craven
Email: send email
Telefono: 442087000000
Fax: 442087000000

UK (LONDON) participant 529˙200.00
5    OSPEDALE PEDIATRICO BAMBINO GESU

 Organization address address: PIAZZA SAN ONOFRIO 4
city: ROMA
postcode: 165

contact info
Titolo: Prof.
Nome: Paolo
Cognome: Rossi
Email: send email
Telefono: 390669000000
Fax: 390669000000

IT (ROMA) participant 504˙515.00
6    UNIVERSITA DEGLI STUDI DI MILANO

 Organization address address: Via Festa Del Perdono 7
city: MILANO
postcode: 20122

contact info
Titolo: Dr.
Nome: Maria Antonia
Cognome: Giofrè
Email: send email
Telefono: +39 02 50320435
Fax: +39 02 50320430

IT (MILANO) participant 441˙795.00
7    CONSORZIO PER VALUTAZIONI BIOLOGICHE E FARMACOLOGICHE

 Organization address address: VIA LUIGI PORTA 14
city: PAVIA
postcode: 27100

contact info
Titolo: Dr.
Nome: Donato
Cognome: Bonifazi
Email: send email
Telefono: +39 080 9751974
Fax: +39 080 9727756

IT (PAVIA) participant 400˙275.00
8    ARISTOTELIO PANEPISTIMIO THESSALONIKIS

 Organization address address: Administration Building, University Campus
city: THESSALONIKI
postcode: 54124

contact info
Titolo: Prof.
Nome: Emmanuel
Cognome: Roilides
Email: send email
Telefono: 302311000000
Fax: 302311000000

EL (THESSALONIKI) participant 384˙594.00
9    SERVICIO MADRILENO DE SALUD

 Organization address address: PLAZA CARLOS TRIAS BERTRAN 7
city: MADRID
postcode: 28020

contact info
Titolo: Ms.
Nome: Ana
Cognome: Herrera Puerta
Email: send email
Telefono: 349727576
Fax: 34912701061

ES (MADRID) participant 194˙501.00
10    STICHTING KATHOLIEKE UNIVERSITEIT

 Organization address address: GEERT GROOTEPLEIN NOORD 9
city: NIJMEGEN
postcode: 6525 EZ

contact info
Titolo: Mr.
Nome: Wim
Cognome: Van Oijen
Email: send email
Telefono: 31243618937
Fax: 31243540529

NL (NIJMEGEN) participant 155˙292.00
11    VIESOJI ISTAIGA VILNIAUS UNIVERSITETO LIGONINES SANTARISKIU KLINIKOS

 Organization address address: SANTARISKIU G 2
city: VILNIUS
postcode: 8661

contact info
Titolo: Ms.
Nome: Jolanta
Cognome: Bilinskaite
Email: send email
Telefono: +370 5 250 1826
Fax: +370 5 236 5111

LT (VILNIUS) participant 144˙207.00
12    EUROPEAN SOCIETY FOR PAEDIATRIC INFECTIOUS DISEASES (ESPID) EV

 Organization address address: SCHACKSTRASSE 2
city: MUNCHEN
postcode: 80539

contact info
Titolo: Prof.
Nome: Ulrich
Cognome: Heininger
Email: send email
Telefono: +41 61 685 6528
Fax: +41 61 685 60 12

DE (MUNCHEN) participant 5˙376.00

Mappa


 Word cloud

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

aged    intensive    pharmacodynamic    meropenem    resistance    months    antibiotics    overcome    sepsis    meningitis    haematological    safe    neomero    late    pk    admitted    infections    life    strategy    pharmacokinetic    lt    therapy    neonates    antibiotic    standard    events    protocols    adverse    trials    bacterial    clinical    good    treating    regarding    bm    efficacy    onset    monitoring    antimicrobial    infants    safety    biochemical    nicu    neonatal    care    administration    resistant   

 Obiettivo del progetto (Objective)

'Previous studies have demonstrated the high frequency of bacterial sepsis in neonates and infants admitted to neonatal intensive care unit (NICU), often associated with serious complications or death. Many pathogens capable of causing nosocomial bacterial sepsis in neonates and young infants have developed resistance to the antibiotics considered of choice for treatment. Meropenem is an antibiotic that can overcome antimicrobial resistance, generally being safe and well tolerated with very good pharmacokinetic (PK) and pharmacodynamic characteristics. However, it has not yet been registered in neonates and infants aged <3 months due to limited data on its PK characteristics, activity and safety. Core objectives of NeoMero are to evaluate the PK, safety and efficacy of meropenem in comparison to standard care in neonates and infants aged <3 months suffering from late-onset sepsis and describe PK and safety in bacterial meningitis (BM). To achieve these aims, clinical trials on meropenem use for late-onset sepsis and BM will be developed. Using previously published PK models, a sampling scheme will be designed and population PK analysis used to identify relevant PK parameters. Safety will be evaluated through analysis of haematological and biochemical parameters and monitoring adverse events. Appearance of resistant bacteria will be monitored through regular cultures during therapy. Clinical assessments including neurological and developmental evaluations (Bayley Scales) will be conducted during two years after enrolment. Immunologic and genetic studies will also be performed to evaluate predictors of susceptibility to infections and response to therapy. In addition, resistant bacterial isolates will be studied to elucidate the mechanism of resistance and sensitive PCR assays will be used to test culture negative samples. A Paediatric Investigators Plan will be developed and submitted to the EMEA. The results of this study will then be used to develop a PUMA.'

Introduzione (Teaser)

Neonatal admission to the intensive care unit (NICU) is very often accompanied by sepsis and bacterial meningitis (BM), which can prove fatal in nearly one third of the cases. A European randomised clinical trial is evaluating the efficacy of alternative treatments to tackle these life-threatening bacterial infections.

Descrizione progetto (Article)

Aggressive antibiotic administration is the most effective therapeutic strategy to combat pathogen spread to the blood and cerebrospinal fluid (CSF) in neonates with sepsis or BM. However, the emergence of antibiotic-resistant bacterial species provides an extra complication.

Meropenem is an antibiotic that can overcome antimicrobial resistance and is especially suitable for treating late-onset sepsis and BM. It has a broad antimicrobial activity, and a safe profile with good pharmacokinetic and pharmacodynamic properties. However, little information regarding its administration in the first months of life is known.

To address this, the EU-funded http://www.neomero.org/ (NEOMERO) project has set out to perform two clinical trials. These trials will compare the efficacy and pharmacokinetics of meropenem to other standard antibiotics for treating NICU infants admitted for sepsis or BM.

The protocols have been established and approved by the relevant ethics committees and national authorities. Standard operating protocols regarding Mmeropenem dose and mode of administration have been agreed and patients have been enrolled in participating European countries. Significant effort has also been dedicated to the analysis of haematological and biochemical parameters as well as the monitoring of adverse events.

Outcomes of the NEOMERO clinical trials will ensure the safe administration of Meropenem in neonates as a strategy for treating sepsis and meningitis.

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