Neonatal Vancomycin Trial — NeoVanc  

Late Onset Neonatal Sepsis Clinical Trial

Official 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 With Late Onset Bacterial Sepsis Known or Suspected to be Caused by Gram-positive Microorganisms

Status Terminated

Clinical Trial Summary

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

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Late Onset Neonatal Sepsis
• Neonatal Sepsis
• Sepsis

• NCT number: NCT02790996
• Study type: Interventional
• Source: PENTA Foundation
• Status: Terminated
• Phase: Phase 2
• Start date: February 27, 2017
• Completion date: April 1, 2020