NCT02210169

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
111

participants targeted

Target at P25-P50 for not_applicable sepsis

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable sepsis

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 6, 2014

Completed
26 days until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

November 2, 2018

Status Verified

October 1, 2018

Enrollment Period

3.6 years

First QC Date

August 5, 2014

Last Update Submit

October 31, 2018

Conditions

SepsisInfectionBacteremia

Outcome Measures

Primary Outcomes (1)

  • Proportion of neonates achieving target vancomycin concentrations in blood at steady state (24-48 hours)

    2 years

Secondary Outcomes (6)

  • Drug-related adverse effects

    2 years

  • Time to achieve target levels

    2 years

  • Clearance of vancomycin in young infants

    2 years

  • Volume of distribution of vancomycin in young infants

    2 years

  • Area under the concentration-time curve of vancomycin in young infants

    2 years

  • +1 more secondary outcomes

Study Arms (2)

Intermittent infusion of vancomycin

NO INTERVENTION

Vancomycin will be administered intravenously over 1 hour. Doses will be given from one to four times a day according to corrected gestational age.

Continuous infusion of vancomycin

ACTIVE COMPARATOR

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

Interventions

Continuous infusion of vancomycinDRUG

Continuous infusion of vancomycin will be given as a loading dose over 1 hour then as a continuous infusion over a 24-hours period.

Continuous infusion of vancomycin

Eligibility Criteria

AgeUp to 90 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Royal Hospital for Women

Sydney, New South Wales, 2031, Australia

Location

The Royal Children's Hospital

Melbourne, Victoria, 3052, Australia

Location

Related Publications (2)

  • Gwee A, Cranswick N, McMullan B, Perkins E, Bolisetty S, Gardiner K, Daley A, Ward M, Chiletti R, Donath S, Hunt R, Curtis N. Continuous Versus Intermittent Vancomycin Infusions in Infants: A Randomized Controlled Trial. Pediatrics. 2019 Feb;143(2):e20182179. doi: 10.1542/peds.2018-2179.

    PMID: 30700564DERIVED

  • Gwee A, Cranswick N, Donath SM, Hunt R, Curtis N. Protocol for a randomised controlled trial of continuous infusions of vancomycin to improve the attainment of target vancomycin levels in young infants: The VANC trial. BMJ Open. 2018 Nov 3;8(11):e022603. doi: 10.1136/bmjopen-2018-022603.

    PMID: 30391914DERIVED

MeSH Terms

Conditions

SepsisInfectionsBacteremia

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsBacterial InfectionsBacterial Infections and Mycoses

Study Officials

  • Amanda Gwee, MBBS

    Murdoch Childrens Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2014

First Posted

August 6, 2014

Study Start

September 1, 2014

Primary Completion

April 1, 2018

Study Completion

May 1, 2018

Last Updated

November 2, 2018

Record last verified: 2018-10

Locations

AU(2)