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RCT of Continuous Versus Intermittent Infusion of Vancomycin in Neonates

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ClinicalTrials.gov Identifier: NCT02210169
Recruitment Status : Completed
First Posted : August 6, 2014
Last Update Posted : November 2, 2018
Sponsor:
Collaborators:
Royal Children's Hospital
Royal Hospital For Women
Information provided by (Responsible Party):
Murdoch Childrens Research Institute

Tracking Information
First Submitted Date  ICMJE August 5, 2014
First Posted Date  ICMJE August 6, 2014
Last Update Posted Date November 2, 2018
Study Start Date  ICMJE September 2014
Actual Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2018)
Proportion of neonates achieving target vancomycin concentrations in blood at steady state (24-48 hours) [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 5, 2014)
Proportion of neonates achieving target vancomycin concentrations in blood at steady state (48 hours) [ Time Frame: 2 years ]
Change History Complete list of historical versions of study NCT02210169 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2018)
  • Drug-related adverse effects [ Time Frame: 2 years ]
    the proportion of drug-related adverse effects with CIV compared to IIV
  • 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
  • Clearance of vancomycin in young infants [ Time Frame: 2 years ]
    Population pharmacokinetic modelling of vancomycin in young infants using NONMEM
  • Volume of distribution of vancomycin in young infants [ Time Frame: 2 years ]
    Population pharmacodynamics modelling of vancomycin in young infants using NONMEM
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE RCT of Continuous Versus Intermittent Infusion of Vancomycin in Neonates
Official Title  ICMJE A Randomised Controlled Trial (RCT) of Continuous and Intermittent Infusion of Vancomycin in Neonates
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Sepsis
  • Infection
  • Bacteremia
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Continuous infusion of vancomycin
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 31, 2018)
111
Original Estimated Enrollment  ICMJE
 (submitted: August 5, 2014)
200
Actual Study Completion Date  ICMJE May 2018
Actual Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 90 Days   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02210169
Other Study ID Numbers  ICMJE Vanc_IIV vs CIV
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Murdoch Childrens Research Institute
Study Sponsor  ICMJE Murdoch Childrens Research Institute
Collaborators  ICMJE
  • Royal Children's Hospital
  • Royal Hospital For Women
Investigators  ICMJE
Principal Investigator: Amanda Gwee, MBBS Murdoch Children's Research Institute
PRS Account Murdoch Childrens Research Institute
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP