Last updated on June 2018

Neonatal Vancomycin Trial

Brief description of study

The study aims 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

Detailed Study Description

Detailed objectives of the study are:

  • To compare the efficacy of an optimised vancomycin dosing regimen to a standard vancomycin dosing regimen in patients with late onset, bacterial sepsis, known or suspected to be caused by Gram-positive microorganisms.
  • To compare the safety of vancomycin (including renal and hearing safety) by allocation group in the intention to treat (ITT) population
  • To describe the PK parameters according to vancomycin dosing regimen and outcome using population PK modelling in the ITT population
  • To describe PK/PD in terms of the probability of target attainment (PTA) with different vancomycin dosing regimens in the ITT and per protocol (PP) populations
  • To describe outcomes and duration of therapy at the end of vancomycin treatment and at the short term follow-up visit by allocation group in the ITT and PP populations
  • To compare the clinical outcome to the antibacterial susceptibility of infecting organisms
  • To compare colonisation by resistant microorganisms (e.g. vancomycin-resistant enterococci (VRE)) and Candida spp. by allocation group at baseline, TOC and short-term follow-up
  • To validate across multiple centres a host biomarker panel to allow improved diagnosis of bacterial sepsis and monitor response to antibacterial therapy

Clinical Study Identifier: NCT02790996

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