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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

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.

Condition or disease Intervention/treatment Phase
Sepsis Infection Bacteremia Drug: Continuous infusion of vancomycin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial (RCT) of Continuous and Intermittent Infusion of Vancomycin in Neonates
Study Start Date : September 2014
Actual Primary Completion Date : April 2018
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Proportion of neonates achieving target vancomycin concentrations in blood at steady state (24-48 hours) [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Drug-related adverse effects [ Time Frame: 2 years ]
    the proportion of drug-related adverse effects with CIV compared to IIV

  2. 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

  3. Clearance of vancomycin in young infants [ Time Frame: 2 years ]
    Population pharmacokinetic modelling of vancomycin in young infants using NONMEM

  4. Volume of distribution of vancomycin in young infants [ Time Frame: 2 years ]
    Population pharmacodynamics modelling of vancomycin in young infants using NONMEM

  5. 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

  6. 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



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Ages Eligible for Study:   up to 90 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02210169


Locations
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Australia, New South Wales
Royal Hospital for Women
Sydney, New South Wales, Australia, 2031
Australia, Victoria
The Royal Children's Hospital
Melbourne, Victoria, Australia, 3052
Sponsors and Collaborators
Murdoch Childrens Research Institute
Royal Children's Hospital
Royal Hospital For Women
Investigators
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Principal Investigator: Amanda Gwee, MBBS Murdoch Children's Research Institute

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Murdoch Childrens Research Institute
ClinicalTrials.gov Identifier: NCT02210169     History of Changes
Other Study ID Numbers: Vanc_IIV vs CIV
First Posted: August 6, 2014    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: October 2018

Additional relevant MeSH terms:
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Bacteremia
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents