Improving Dosing of Vancomycin in Young Infants With Infections
Condition: Sepsis; Infection; Bacteremia
MeSH terms: Infections; Bacteremia
Study type: Interventional
Phase: Phase 4

Summary: 
      Current dosing regimens for vancomycin result in many young infants not reaching the target
      level of vancomycin in the blood at steady state (when the blood is in equilibrium at 24-48
      hours).The purpose of this study is to assess an improved method of calculating the dose of
      vancomycin ('model-based dosing') in young infants with infections in order for them to
      achieve the target vancomycin level at steady state. A dosing calculator (which will be
      available through a web application) will be used for the dose calculation.
    

Detailed description: 
      Standard of care dosing of vancomycin in young infants is based on weight (eg. 15
      mg/kg/dose). There is evidence that many young infants who are prescribed vancomycin using
      this calculation will not have enough vancomycin in the blood at steady state to treat an
      infection effectively. In this study a dosing calculator will be used to generate each
      participant's dose with the aim to improve the number of participant's who achieve the target
      vancomycin level (10 - 20 mg/L) at steady state. The dosing calculator is based on a
      pharmacokinetic/pharmacodynamic model of vancomycin which was built from prospective data.
      The participant's weight, post-menstrual age, creatinine and target vancomycin level will be
      entered into the dosing calculator (available on a web application), and the calculator will
      provide the dosing regimen for that participant. The participant will have the vancomycin
      level checked at 24-48 hours to assess if the target level has been achieved.

      This study is 'part 1' of the study protocol (version 4.0) as approved under HREC reference
      number HREC/51942/RCHM-2019. This protocol also includes a second study, 'part 2', which will
      be registered with clinicaltrials.gov separately. Part 2 will assess the use of early drug
      monitoring and early dose adjustment to achieve the target vancomycin level in the blood at
      steady state. Part 1 of this protocol will be completed before part 2 begins recruitment.
      Part 1 and part 2 are two separate studies and the results of each part will not be compared
      to one another. However, each part will be compared to a retrospective control arm - infants
      from the VANC randomized controlled trial (NCT02210169) who received standard intermittent
      infusion of vancomycin dosing (as per British National Formulary for children. 15mg/kg/dose)
      and standard therapeutic drug monitoring.
    

Intervention name(s): Vancomycin - model-based dosing regimen
Intervention type(s): Drug
Intervention description(s): A dosing calculator based on a population pharmacokinetic model for vancomycin will be used to generate a participant's intermittent vancomycin dosing regimen. The participant's post-menstrual age, weight, creatinine and the target trough vancomycin level will be entered into the dosing calculator and the dose will be generated (intermittent infusion, dosing frequency will be from 1 to 4 times per day according to the corrected gestational age).
Intervention MeSH terms: Vancomycin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment