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

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.

Field of science

  • /natural sciences/biological sciences/microbiology/bacteriology
  • /medical and health sciences/basic medicine/pharmacology and pharmacy/pharmacokinetics
  • /medical and health sciences/clinical medicine/critical care medicine
  • /medical and health sciences/basic medicine/pharmacology and pharmacy/drug resistance/antibiotic resistance

Call for proposal

FP7-HEALTH-2009-single-stage
See other projects for this call

Funding Scheme

CP-FP - Small or medium-scale focused research project

Coordinator

FONDAZIONE PENTA - FOR THE TREATMENT AND CARE OF CHILDREN WITH HIV ANDRELATED DISEASES - ONLUS
Address
Corso Stati Uniti 4
35127 Padova
Italy
Activity type
Research Organisations
EU contribution
€ 1 963 921
Administrative Contact
Silvia Faggion (Dr.)

Participants (11)

OSPEDALE PEDIATRICO BAMBINO GESU
Italy
EU contribution
€ 504 515
Address
Piazza Sant Onofrio 4
00165 Roma
Activity type
Other
Administrative Contact
Paolo Rossi (Prof.)
UNIVERSITA DEGLI STUDI DI MILANO
Italy
EU contribution
€ 441 795
Address
Via Festa Del Perdono 7
20122 Milano
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Maria Antonia Giofrè (Dr.)
ST GEORGE'S HOSPITAL MEDICAL SCHOOL
United Kingdom
EU contribution
€ 529 200
Address
Cranmer Terrace
SW17 0RE London
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Paul Craven (Dr.)
INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE
France
EU contribution
€ 635 204
Address
Rue De Tolbiac 101
75654 Paris
Activity type
Research Organisations
Administrative Contact
Jean-Pierre Aboulker (Dr.)
EUROPEAN SOCIETY FOR PAEDIATRIC INFECTIOUS DISEASES (ESPID) EV
Germany
EU contribution
€ 5 376
Address
Schackstrasse 2
80539 Munchen
Activity type
Research Organisations
Administrative Contact
Ulrich Heininger (Prof.)
TARTU ULIKOOL
Estonia
EU contribution
€ 541 120
Address
Ulikooli 18
51005 Tartu
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Irja Lutsar (Prof.)
STICHTING KATHOLIEKE UNIVERSITEIT
Netherlands
EU contribution
€ 155 292
Address
Geert Grooteplein Noord 9
6525 EZ Nijmegen
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Wim Van Oijen (Mr.)
ARISTOTELIO PANEPISTIMIO THESSALONIKIS
Greece
EU contribution
€ 384 594
Address
Kedea Building, Tritis Septemvriou, Aristotle Univ Campus
54636 Thessaloniki
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Emmanuel Roilides (Prof.)
SERVICIO MADRILENO DE SALUD
Spain
EU contribution
€ 194 501
Address
Plaza Carlos Trias Bertran 7
28020 Madrid
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
Ana Herrera Puerta (Ms.)
CONSORZIO PER VALUTAZIONI BIOLOGICHE E FARMACOLOGICHE
Italy
EU contribution
€ 400 275
Address
Via Nicolo Putignani 178
70122 Bari
Activity type
Research Organisations
Administrative Contact
Donato Bonifazi (Dr.)
VIESOJI ISTAIGA VILNIAUS UNIVERSITETO LIGONINE SANTAROS KLINIKOS
Lithuania
EU contribution
€ 144 207
Address
Santariskiu G 2
08661 Vilnius
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
Jolanta Bilinskaite (Ms.)