Wednesday, 16 August 2017

Objectives

Vancomycin was included in the “Revised priority list for studies into off- patent paediatric medicinal products” (Doc. Ref. EMA/98717/2012). According to the list, data on an optimal dosing and monitoring regimen (e.g. pharmacokinetics/pharmacodynamics and safety based efficacy studies in preterm and term neonates and infants) together with an age-appropriate formulation for neonates with sepsis caused by staphylococci and nonpyogenic streptococci are requested. The Paediatric Regulation EC 1901/2006 states that “medicinal products no longer covered by a patent” can be eligible for a PUMA (Paediatric Use Marketing Authorisation).

The aims of this project include developing an age-appropriate formulation (new strength: 125 mg vial) suitable for vancomycin in neonates and infants aged less than 3 months without a dilutional step, an optimised dosing regimen and recommendations for therapeutic drug monitoring in this age group, evaluating the efficacy and safety of this optimised dose compared to current, standard treatment and subsequently to obtain a new PUMA for vancomycin for this age and indication.

Built on previously FP7 funded experiences "Neomero" and "TiNN", this project will pursue the following specific objectives:

I) To define the preclinical Pharmacokinetic (PK) / Pharmacodynamic (PD) relationships for vancomycin against clinically relevant Gram positive pathogens in hollow fibre infection and laboratory animal models and bridge the results to human neonates (NeoVanc 1).

II) To conduct a population PK meta-analysis of all available neonatal vancomycin data and define in collaboration with NeoVanc 1, a new optimal vancomycin dosing regimen (NeoVanc 2).

III) To compare a new improved "Optimal" vancomycin dosing regimen with an accepted European standard of care regimen in a Phase II RCT in terms of efficacy and safety (NeoVanc 3).

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This project has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no: 602041
Call: FP7-HEALTH-2013-INNOVATION-1
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