Whole blood mRNA transcription profiling of host immune changes in neonatal sepsis during vancomycin therapy

The purpose of this study was to investigate changes in host gene expression profiles of neonatal infants with sepsis prior to the initiation of and during vancomycin therapy, to identify treatment-responsive genes and signature pathways associated with recovery from neonatal sepsis. The study analyzed data from a subset of 35 infants recruited to the NeoVanc trial, a multi-center randomized open label phase IIb study which compared the efficacy, safety and pharmacokinetics of an optimized dosing to a standard dosing regimen of vancomycin in neonates and infants aged less than 90 days with late onset bacterial sepsis (ClinicalTrials.gov ID: NCT02790996). All infants selected had a positive blood culture for Staphylococcus epidermidis in addition to a clinical diagnosis of neonatal sepsis. Whole blood samples were collected for each infant at five time points between the time of randomization to the trial until a short term follow up visit, approximately 30 days after randomization.