Neonatal Vancomycin 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

Conditions

• Late Onset Neonatal Sepsis

Interventions

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.

Sponsors & Collaborators

• St George's, University of London

  collaborator OTHER

• Hopital Universitaire Robert-Debre

  collaborator OTHER

• University of Tartu

  collaborator OTHER

• Consorzio per Valutazioni Biologiche e Farmacologiche

  collaborator OTHER

• University of Liverpool

  collaborator OTHER

• Therakind limited

  collaborator UNKNOWN

• Bambino Gesù Hospital and Research Institute

  collaborator OTHER

• Servicio Madrileño de Salud, Madrid, Spain

  collaborator OTHER

• Aristotle University Of Thessaloniki

  collaborator OTHER

• Cardiff University

  collaborator OTHER

• SYNAPSE Research Management Partners S.L

  collaborator UNKNOWN

• European Commission

  collaborator OTHER

• PENTA Foundation

  lead NETWORK

Principal Investigators

• Mike Sharland, MD, FRCPCH · St George's, University of London

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

72 Hours

Max Age

90 Days

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-02-27

Primary Completion

2020-04-01

Completion

2020-04-01

Countries

• Estonia
• Greece
• Italy
• Spain
• United Kingdom

Study Locations