Neonatal Vancomycin Trial (NeoVanc)
Research type
Research Study
Full title
Multi-centre, randomised, open label, phase IIb study to compare the efficacy, safety and pharmacokinetics (PK) of an optimised dosing to a standard dosing regimen of vancomycin in neonates and infants aged 90 days or less with late onset bacterial sepsis known or suspected to be caused by Gram-positive microorganisms
IRAS ID
202065
Contact name
Louise Hill
Contact email
Sponsor organisation
Fondazione PENTA Onlus
Eudract number
2015-000203-89
Duration of Study in the UK
1 years, 9 months, 30 days
Research summary
Multi-centre, randomised, open-label, phase IIb, study to compare the efficacy, safety and pharmacokinetics (PK) of an optimised dosing to a standard dosing regimen of vancomycin in neonates and infants aged <90 days with late onset bacterial sepsis known or suspected to be caused by Gram-positive microorganisms.
NeoVanc is a study looking at how best to give an antibiotic called vancomycin to babies with sepsis. Sepsis is an infection of the blood that is usually caused by germs called bacteria. Sepsis needs to be treated with antibiotics quickly.
There are different antibiotics that can be given to treat infections in young babies, however, not many studies have been done in this group to see which antibiotics work best. Most of what we know about antibiotics in babies we have learned from studies in older children and adults. We would like to find out what the most effective way of giving vancomycin in young babies is. We will compare how vancomycin is currently given to a new regimen that has been devised with babies in mind. We will randomise babies (which is a bit like “tossing a coin”) to decide whether they will receive the standard or new vancomycin regimen.
There are between 7 and 9 episodes involving each baby throughout the study – in many cases most of these will happen whilst the baby is in hospital and several visits can be merged or will form part of routine care e.g. hearing screening. Each baby will participate for a maximum of 90 days.
The study is for babies between over 3 days old but less than 91 days old. We plan to recruit participants from Estonia, Greece, Italy, Spain and the United Kingdom. NeoVanc is funded by the European Commission.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
16/LO/1026
Date of REC Opinion
18 Jul 2016
REC opinion
Further Information Favourable Opinion