NeoVanc
Treatment of late onset bacterial sepsis caused by vancomycin susceptible bacteria in neonates and infants aged under three months
Project's status: Recruitment of patients has been started
- NeoVanc 1: 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 2: 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 3: 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.
Link
EUDRA-CT
2015-000203-89
Funding
European Commission, under the FP7 programme
Partners
- University of Tartu; Tartu University Hospital
- Tallinn Children's Hospital
People involved with the project
