RCT of Continuous Versus Intermittent Infusion of Vancomycin in Neonates

October 31, 2018 updated by: Murdoch Childrens Research Institute

A Randomised Controlled Trial (RCT) of Continuous and Intermittent Infusion of Vancomycin in Neonates

Babies aged 0 to 90 days with a suspected infection requiring treatment with vancomycin will be recruited. They will be randomised to receive vancomycin as an intermittent infusion (over 1 hour) or as a continuous infusion (over 24 hours). The hypothesis is that administering vancomycin as a continuous infusion will result in improved attainment of target concentrations in blood at steady state (when the drug is in equilibrium) compared to intermittent infusion.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

111

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2031
        • Royal Hospital for Women
    • Victoria
      • Melbourne, Victoria, Australia, 3052
        • The Royal Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 months (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- Neonates in the neonatal unit with an infection requiring treatment with vancomycin as determined by the treating physician.

Exclusion Criteria:

  • Infants with a corrected gestational age < 25 weeks.
  • Allergy to vancomycin or other glycopeptide antibiotic
  • Vancomycin administered within the previous 72 hours
  • Renal impairment
  • Prior enrolment in the study
  • Need for drug that is incompatible with vancomycin (if no other IV line is available)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Intermittent infusion of vancomycin
Vancomycin will be administered intravenously over 1 hour. Doses will be given from one to four times a day according to corrected gestational age.
ACTIVE_COMPARATOR: Continuous infusion of vancomycin
A loading dose of vancomycin will be given over 1 hour followed by a continuous infusion of vancomycin over a 24 hour period.
Drug: Continuous infusion of vancomycin
Continuous infusion of vancomycin will be given as a loading dose over 1 hour then as a continuous infusion over a 24-hours period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of neonates achieving target vancomycin concentrations in blood at steady state (24-48 hours)
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Drug-related adverse effects
Time Frame: 2 years
the proportion of drug-related adverse effects with CIV compared to IIV
2 years
Time to achieve target levels
Time Frame: 2 years
the time to and number of dose adjustments required to achieve target therapeutic vancomycin levels in blood
2 years
Clearance of vancomycin in young infants
Time Frame: 2 years
Population pharmacokinetic modelling of vancomycin in young infants using NONMEM
2 years
Volume of distribution of vancomycin in young infants
Time Frame: 2 years
Population pharmacodynamics modelling of vancomycin in young infants using NONMEM
2 years
Area under the concentration-time curve of vancomycin in young infants
Time Frame: 2 years
Population pharmacodynamics modelling of vancomycin in young infants using NONMEM
2 years
Time above the minimum inhibitory concentration of the bacteria for vancomycin in young infants
Time Frame: 2 years
Population pharmacodynamics modelling of vancomycin in young infants using NONMEM
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Murdoch Childrens Research Institute

Collaborators

Royal Children's Hospital
Royal Hospital For Women

Investigators

  • Principal Investigator: Amanda Gwee, MBBS, Murdoch Children'S Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (ACTUAL)

April 1, 2018

Study Completion (ACTUAL)

May 1, 2018

Study Registration Dates

First Submitted

August 5, 2014

First Submitted That Met QC Criteria

August 5, 2014

First Posted (ESTIMATE)

August 6, 2014

Study Record Updates

Last Update Posted (ACTUAL)

November 2, 2018

Last Update Submitted That Met QC Criteria

October 31, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Vanc_IIV vs CIV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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