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

akronüüm: NEOMERO
algus: 2010-01-01
lõpp: 2013-12-31
 
programm: FP7 - Euroopa Liidu 7. raamprogramm
alaprogramm: HEALTH - Tervis
instrument: CP-FP - Väikese- ja keskmisemahulised koostööprojektid
projektikonkurss: FP7-HEALTH-2009-single-stage
projekti number: 242146
kestus kuudes: 48
partnerite arv: 12
 
lühikokkuvõte: 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.
partneri jrk nr ja roll partneri nimi riik kontaktisik koduleht
1 koordinaator FONDAZIONE PENTA-FOR THE TREATMENT AND CARE OF CHILDREN WITH HIV-ONLUS IT Silvia Faggion
2 partner OSPEDALE PEDIATRICO BAMBINO GESU IT Paolo Rossi http://www.ospedalebambinogesu.it
3 partner UNIVERSITA DEGLI STUDI DI MILANO IT Maria Antonia Giofrè http://www.unimi.it
4 partner ST GEORGE'S HOSPITAL MEDICAL SCHOOL UK Paul Craven http://www.sghms.ac.uk
5 partner INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM) FR Jean-Pierre Aboulker http://www.inserm.fr
6 partner EUROPEAN SOCIETY FOR PAEDIATRIC INFECTIOUS DISEASES (ESPID) EV DE Ulrich Heininger http://www.espid.org
7 partner Tartu Ülikool EE Irja Lutsar http://www.ut.ee
8 partner STICHTING KATHOLIEKE UNIVERSITEIT NL Wim Van Oijen http://www.ru.nl
9 partner ARISTOTELIO PANEPISTIMIO THESSALONIKIS EL Emmanuel Roilides http://www.auth.gr
11 partner SERVICIO MADRILENO DE SALUD ES Ana Herrera Puerta http://cort.as/10Yf
12 partner CONSORZIO PER VALUTAZIONI BIOLOGICHE E FARMACOLOGICHE IT Paola Baiardi http://www.cvbf.net
13 partner VIESOJI ISTAIGA VILNIAUS UNIVERSITETO LIGONINES SANTARISKIU KLINIKOS LT Jolanta Bilinskaite http://www.santa.lt