NEOMERO2 - PK and Safety of Meropenem in Infants with Meningitis (V1)

• Research type

  Research Study

• Full title

  Neomero2. Pharmacokinetics and safety of Meropenem in infants below 90 days of age (inclusive) with probable and confirmed meningitis: A European Multicenter Phase II Trial

• IRAS ID

  53628

• Contact name

  Paul Heath

• Sponsor organisation

  St George's, University of London

• Eudract number

  2011-001521-25

• ISRCTN Number

  n.a

• Research summary

  NeoMero2 aims to evaluate the pharmacokinetic (PK) characteristics and safety of Meropenem in neonates and infants aged = 90 days with bacterial meningitis. Prompt initiation of effective empiric antibiotic therapy is essential to optimize outcome when bacterial meningitis (BM) is suspected. Meropenem covers a broad range of pathogens common in this age group, many of which have developed increasing resistance to conventional antibiotics, but it is currently only licensed for use in children aged > 3 months. This multicentre, international trial will include approximately 30 hospitals within the UK with an aim to recruit up to 40 UK children. Participating infants with probable or confirmed BM will be treated with Meropenem and samples obtained to assess PK and microbiological endpoints. We anticipate that the trial results will facilitate the safe use of Meropenem in neonates and infants with meningitis and assure that the proper dose is defined.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  11/LO/1857

• Date of REC Opinion

  25 Jan 2012

• REC opinion

  Further Information Favourable Opinion