NCT02790996

Neonatal Vancomycin Trial

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 242 (actual)
• Sponsor: PENTA Foundation · Network
• Sex: All
• Age: 72 Hours – 90 Days
• Healthy volunteers: Not accepted

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

Detailed 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

Conditions

• Late Onset Neonatal Sepsis

Interventions

Type	Name	Description
DRUG	Vancomycin	Vancomycin is an antibiotic used to treat a number of bacterial infections.It is recommended intravenously as a treatment for complicated skin infections, bloodstream infections, endocarditis, bone and joint infections, and meningitis caused by methicillin-resistant S. aureus.

Timeline

• Start date: 2017-02-27
• Primary completion: 2020-04-01
• Completion: 2020-04-01
• First posted: 2016-06-06
• Last updated: 2020-09-09

Locations

18 sites across 5 countries: Estonia, Greece, Italy, Spain, United Kingdom