Clinical trial NCT02210169: 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
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis
Infection
Bacteremia
Lead sponsor: Murdoch Childrens Research Institute
Sponsor class: OTHER
Collaborators: name: Royal Children's Hospital
name: Royal Hospital For Women
First posted: 2014-08-06
Enrollment: 111
Sex: ALL
Maximum age (years): 90
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Proportion of neonates achieving target vancomycin concentrations in blood at steady state (24-48 hours)
timeFrame: 2 years
Secondary outcomes:
measure: Drug-related adverse effects
timeFrame: 2 years
measure: Time to achieve target levels
timeFrame: 2 years
measure: Clearance of vancomycin in young infants
timeFrame: 2 years
measure: Volume of distribution of vancomycin in young infants
timeFrame: 2 years
measure: Area under the concentration-time curve of vancomycin in young infants
timeFrame: 2 years
measure: Time above the minimum inhibitory concentration of the bacteria for vancomycin in young infants
timeFrame: 2 years
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Royal Hospital for Women
state: New South Wales
city: Melbourne
country: Australia
facility: The Royal Children's Hospital
state: Victoria
Study officials:
affiliation: Murdoch Childrens Research Institute
name: Amanda Gwee, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.