RCT of Continuous Versus Intermittent Infusion of Vancomycin in Neonates
- Conditions
- SepsisInfectionBacteremia
- 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
- Neonates in the neonatal unit with an infection requiring treatment with vancomycin as determined by the treating physician.
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Continuous infusion of vancomycin 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.
- Primary Outcome Measures
Name Time Method Proportion of neonates achieving target vancomycin concentrations in blood at steady state (24-48 hours) 2 years
- Secondary Outcome Measures
Name Time Method Drug-related adverse effects 2 years the proportion of drug-related adverse effects with CIV compared to IIV
Clearance of vancomycin in young infants 2 years Population pharmacokinetic modelling of vancomycin in young infants using NONMEM
Volume of distribution of vancomycin in young infants 2 years Population pharmacodynamics modelling of vancomycin in young infants using NONMEM
Area under the concentration-time curve of vancomycin in young infants 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 2 years Population pharmacodynamics modelling of vancomycin in young infants using NONMEM
Time to achieve target levels 2 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