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OpenTrials
Completed

NCT Number: NCT02210169

RCT of Continuous Versus Intermittent Infusion of Vancomycin in Neonates

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.

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Key information

Conditions

Sepsis Bacteremia Bacterial Infections Bacterial Infections and Mycoses Infection Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

Up to 90 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Hospital for Women, Sydney, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Continuous infusion of vancomycin

Drug

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 outcomes

  1. Proportion of neonates achieving target vancomycin concentrations in blood at steady state (24-48 hours)

    Time frame: 2 years

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Murdoch Childrens Research Institute

Other

Collaborators

  • Royal Children's Hospital
  • Royal Hospital For Women

Registry information

Official study title

A Randomised Controlled Trial (RCT) of Continuous and Intermittent Infusion of Vancomycin in Neonates

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Aug 6, 2014
Registry last updated
Nov 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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