Back to resultsRCT of Continuous Versus Intermittent Infusion of Vancomycin in Neonates
Primary Purpose
Sepsis, Infection, Bacteremia
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Continuous infusion of vancomycin
Sponsored by
About this trial
This is an interventional treatment trial for Sepsis
Eligibility Criteria
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)
Sites / Locations
- Royal Hospital for Women
- The Royal Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Intermittent infusion of vancomycin
Continuous infusion of vancomycin
Arm Description
Vancomycin will be administered intravenously over 1 hour. Doses will be given from one to four times a day according to corrected gestational age.
A loading dose of vancomycin will be given over 1 hour followed by a continuous infusion of vancomycin over a 24 hour period.
Outcomes
Primary Outcome Measures
Proportion of neonates achieving target vancomycin concentrations in blood at steady state (24-48 hours)
Secondary Outcome Measures
Drug-related adverse effects
the proportion of drug-related adverse effects with CIV compared to IIV
Time to achieve target levels
the time to and number of dose adjustments required to achieve target therapeutic vancomycin levels in blood
Clearance of vancomycin in young infants
Population pharmacokinetic modelling of vancomycin in young infants using NONMEM
Volume of distribution of vancomycin in young infants
Population pharmacodynamics modelling of vancomycin in young infants using NONMEM
Area under the concentration-time curve of vancomycin in young infants
Population pharmacodynamics modelling of vancomycin in young infants using NONMEM
Time above the minimum inhibitory concentration of the bacteria for vancomycin in young infants
Population pharmacodynamics modelling of vancomycin in young infants using NONMEM
Full Information
NCT ID
NCT02210169
First Posted
August 5, 2014
Last Updated
October 31, 2018
Sponsor
Murdoch Childrens Research Institute
Collaborators
Royal Children's Hospital, Royal Hospital For Women
1. Study Identification
Unique Protocol Identification Number
NCT02210169
Brief Title
RCT of Continuous Versus Intermittent Infusion of Vancomycin in Neonates
Official Title
A Randomised Controlled Trial (RCT) of Continuous and Intermittent Infusion of Vancomycin in Neonates
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
May 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Murdoch Childrens Research Institute
Collaborators
Royal Children's Hospital, Royal Hospital For Women
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Infection, Bacteremia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
111 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intermittent infusion of vancomycin
Arm Type
No Intervention
Arm Description
Vancomycin will be administered intravenously over 1 hour. Doses will be given from one to four times a day according to corrected gestational age.
Arm Title
Continuous infusion of vancomycin
Arm Type
Active Comparator
Arm Description
A loading dose of vancomycin will be given over 1 hour followed by a continuous infusion of vancomycin over a 24 hour period.
Intervention Type
Drug
Intervention Name(s)
Continuous infusion of vancomycin
Intervention Description
Continuous infusion of vancomycin will be given as a loading dose over 1 hour then as a continuous infusion over a 24-hours period.
Primary Outcome Measure Information:
Title
Proportion of neonates achieving target vancomycin concentrations in blood at steady state (24-48 hours)
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Drug-related adverse effects
Description
the proportion of drug-related adverse effects with CIV compared to IIV
Time Frame
2 years
Title
Time to achieve target levels
Description
the time to and number of dose adjustments required to achieve target therapeutic vancomycin levels in blood
Time Frame
2 years
Title
Clearance of vancomycin in young infants
Description
Population pharmacokinetic modelling of vancomycin in young infants using NONMEM
Time Frame
2 years
Title
Volume of distribution of vancomycin in young infants
Description
Population pharmacodynamics modelling of vancomycin in young infants using NONMEM
Time Frame
2 years
Title
Area under the concentration-time curve of vancomycin in young infants
Description
Population pharmacodynamics modelling of vancomycin in young infants using NONMEM
Time Frame
2 years
Title
Time above the minimum inhibitory concentration of the bacteria for vancomycin in young infants
Description
Population pharmacodynamics modelling of vancomycin in young infants using NONMEM
Time Frame
2 years
10. Eligibility
Sex
All
Maximum Age & Unit of Time
90 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amanda Gwee, MBBS
Organizational Affiliation
Murdoch Children's Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Hospital for Women
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
The Royal Children's Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
12. IPD Sharing Statement
Citations:
PubMed Identifier
30700564
Citation
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.
Results Reference
derived
PubMed Identifier
30391914
Citation
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.
Results Reference
derived
Learn more about this trial
RCT of Continuous Versus Intermittent Infusion of Vancomycin in Neonates
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