Improving Dosing of Vancomycin in Young Infants With Infections

NCT04044703 | Completed Phase 4

• 1 other identifier: HREC2019.059
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Sepsis; Infection; Bacteremia

Outcome Measures

Primary Outcomes (1)

• The proportion of young infants achieving target trough vancomycin concentrations (10 to 20 mg/L) at the first steady-state level when using a model-based dosing regimen

  From first vancomycin dose (immediately after consent) to steady state level taken at 24-48 hours post-first-dose.

Secondary Outcomes (4)

• The proportion of young infants with supra- (defined as >20mg/L) or sub- (defined as <10mg/L) therapeutic vancomycin concentrations at the first steady state level using a model-based dosing regimen (through a web application)

  From first vancomycin dose (immediately after consent) to steady state level taken at 24-48 hours post-first-dose.

• The proportion of young infants who are excluded from the study due to the model-based dosing regimen providing a total daily dose which exceeds 80 mg/kg/day despite a target trough concentration of 10 mg/L.

  From consent to calculation of vancomycin dose (immediately after consent)

• The frequency of drug-related adverse events (including infusion-related adverse events and nephrotoxicity).

  From first vancomycin dose (immediately after consent) to completion of vancomycin therapy (as determined by clinical team, an average of 5 days)

• The frequency of drug administration errors

  From first vancomycin dose to completion of vancomycin therapy (as determined by clinical team, an average of 5 days)

Study Arms (1)

Model-based vancomycin dosing

EXPERIMENTAL

Participants will receive model-based intermittent intravenous vancomycin dosing as calculated by the dosing calculator available on a web application. Participants will then have routine therapeutic drug monitoring and linear dose adjustments.

Drug: Vancomycin - model-based dosing regimen

Interventions

Vancomycin - model-based dosing regimen DRUG

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).

Model-based vancomycin dosing

Eligibility Criteria

• Age: 0 Days - 90 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants aged 0 - 90 days old
• Suspected infection requiring treatment with vancomycin for 48 hours or more (as determined by the clinical team)
• Post-Menstrual age (PMA) matched to PMA-group from retrospective control group

You may not qualify if:

• Infants with corrected gestational age of less than 25 weeks
• Infants weighing less than 500g
• Known allergy to any glycopeptide antibiotic
• Vancomycin administered within the previous 72 hours
• Infants receiving any form of extracorporeal life support
• Renal impairment
• Previously enrolled in the study

Sponsors & Collaborators

• Murdoch Childrens Research Institute: lead
• Royal Children's Hospital: collaborator
• Royal Hospital For Women: collaborator
• University of Otago: collaborator
• Sydney Children's Hospitals Network: collaborator
• Monash Health: collaborator

Study Sites (4)

Royal Hospital for Women

Sydney, New South Wales, 2031, Australia

Location

Children's Hospital at Westmead

Sydney, New South Wales, Australia

Location

Royal Children's Hospital Melbourne

Melbourne, Victoria, 3052, Australia

Location

Monash Children's Hospital

Melbourne, Victoria, Australia

Location

MeSH Terms

Conditions

Sepsis; Infections; Bacteremia

Condition Hierarchy (Ancestors)

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

Study Officials

• Amanda Wilkins, MBBS

  Murdoch Childrens Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Paediatric trainee

Study Record Dates

• First Submitted: July 31, 2019
• First Posted: August 5, 2019
• Study Start: August 30, 2019
• Primary Completion: December 29, 2020
• Study Completion: January 3, 2021
• Last Updated: August 26, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (4)