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RCT of Continuous Versus Intermittent Infusion of Vancomycin in Neonates

Not Applicable
Completed
Conditions
Sepsis
Infection
Bacteremia
Interventions
Drug: Continuous infusion of vancomycin
Registration Number
NCT02210169
Lead Sponsor
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
111
Inclusion Criteria
  • Neonates in the neonatal unit with an infection requiring treatment with vancomycin as determined by the treating physician.
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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)
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Continuous infusion of vancomycinContinuous infusion of vancomycinA loading dose of vancomycin will be given over 1 hour followed by a continuous infusion of vancomycin over a 24 hour period.
Primary Outcome Measures
NameTimeMethod
Proportion of neonates achieving target vancomycin concentrations in blood at steady state (24-48 hours)2 years
Secondary Outcome Measures
NameTimeMethod
Drug-related adverse effects2 years

the proportion of drug-related adverse effects with CIV compared to IIV

Clearance of vancomycin in young infants2 years

Population pharmacokinetic modelling of vancomycin in young infants using NONMEM

Volume of distribution of vancomycin in young infants2 years

Population pharmacodynamics modelling of vancomycin in young infants using NONMEM

Area under the concentration-time curve of vancomycin in young infants2 years

Population pharmacodynamics modelling of vancomycin in young infants using NONMEM

Time above the minimum inhibitory concentration of the bacteria for vancomycin in young infants2 years

Population pharmacodynamics modelling of vancomycin in young infants using NONMEM

Time to achieve target levels2 years

the time to and number of dose adjustments required to achieve target therapeutic vancomycin levels in blood

Trial Locations

Locations (2)

Royal Hospital for Women

🇦🇺

Sydney, New South Wales, Australia

The Royal Children's Hospital

🇦🇺

Melbourne, Victoria, Australia

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