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

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.

Coordinator

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

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OSPEDALE PEDIATRICO BAMBINO GESU

Italy

EU Contribution

€ 504 515

UNIVERSITA DEGLI STUDI DI MILANO

Italy

EU Contribution

€ 441 795

ST GEORGE'S HOSPITAL MEDICAL SCHOOL

United Kingdom

EU Contribution

€ 529 200

INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE

France

EU Contribution

€ 635 204

EUROPEAN SOCIETY FOR PAEDIATRIC INFECTIOUS DISEASES (ESPID) EV

Germany

EU Contribution

€ 5 376

TARTU ULIKOOL

Estonia

EU Contribution

€ 541 120

STICHTING KATHOLIEKE UNIVERSITEIT

Netherlands

EU Contribution

€ 155 292

ARISTOTELIO PANEPISTIMIO THESSALONIKIS

Greece

EU Contribution

€ 384 594

SERVICIO MADRILENO DE SALUD

Spain

EU Contribution

€ 194 501

CONSORZIO PER VALUTAZIONI BIOLOGICHE E FARMACOLOGICHE

Italy

EU Contribution

€ 400 275

VIESOJI ISTAIGA VILNIAUS UNIVERSITETO LIGONINE SANTAROS KLINIKOS

Lithuania

EU Contribution

€ 144 207

Project information

Grant agreement ID: 242146

Status

Closed project

  • Start date

    1 January 2010

  • End date

    30 June 2015

Funded under:

FP7-HEALTH

  • Overall budget:

    € 7 672 901,94

  • EU contribution

    € 5 900 000

Coordinated by:

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

Italy