Meropenem has been included in the revised EMEA “priority list for studies into off patent paediatric medicinal products” (Doc. Ref.EMEA/226983/2008), the list of off-patent drugs intended to address unmet therapeutic needs in children and to increase information on drug uses in paediatrics. Data on pharmacokinetics (PK), efficacy and safety of meropenem in patients below 3 months of age are requested. This aspect is of relevance because, according to the Paediatric Regulation, ‘medicinal products no longer covered by a patent can be eligible for PUMA (Paediatric Use Marketing Authorisation), which will cover exclusively therapeutic indications which are relevant for use in paediatric populations.

Meropenem has been off patent for many years and largely used off label for the treatment of neonatal sepsis and meningitis without sufficient data on pharmacokinetics, safety and efficacy. To overcome these shortcomings, the HEAD-PM project aims to evaluate the pharmacokinetic characteristics, efficacy and safety of meropenem in comparison to standard treatment in neonates and infants aged <3 months suffering from late-onset sepsis and BM. The results obtained will represent a decisive expansion of the available data on the subject, facilitating and expediting the development of the corresponding PUMA.

In order to reach these aims, a comprehensive work plan has been devised, which includes both sepsis and meningitis trials, as well as PK, immunology, genetics and microbiology studies. Regulatory and dissemination activities are also encompassed in the project scope to ensure appropriate use of the results obtained.
Additionally, HEAD-PM is intended to serve as a test-bed for a permanent European network based on a partnership between two well established European paediatric infective diseases networks, PENTA and ESPID, devoted to paediatric antimicrobial studies, which should provide a considerable added value in this area for the future.