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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04044703




Registration number
NCT04044703
Ethics application status
Date submitted
31/07/2019
Date registered
5/08/2019

Titles & IDs
Public title
Improving Dosing of Vancomycin in Young Infants With Infections
Scientific title
The VANcomycin Cohort Study - Assessing Precise Dosing and Prompt Drug Monitoring to Improve Attainment of Target Concentrations (Part 1)
Secondary ID [1] 0 0
HREC2019.059
Universal Trial Number (UTN)
Trial acronym
VANCAPP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sepsis 0 0
Infection 0 0
Bacteremia 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Blood 0 0 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Vancomycin - model-based dosing regimen

Experimental: Model-based vancomycin dosing - 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.


Treatment: Drugs: Vancomycin - model-based dosing regimen
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 code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
From first vancomycin dose (immediately after consent) to steady state level taken at 24-48 hours post-first-dose.
Secondary outcome [1] 0 0
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)
Timepoint [1] 0 0
From first vancomycin dose (immediately after consent) to steady state level taken at 24-48 hours post-first-dose.
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
From consent to calculation of vancomycin dose (immediately after consent)
Secondary outcome [3] 0 0
The frequency of drug-related adverse events (including infusion-related adverse events and nephrotoxicity).
Timepoint [3] 0 0
From first vancomycin dose (immediately after consent) to completion of vancomycin therapy (as determined by clinical team, an average of 5 days)
Secondary outcome [4] 0 0
The frequency of drug administration errors
Timepoint [4] 0 0
From first vancomycin dose to completion of vancomycin therapy (as determined by clinical team, an average of 5 days)

Eligibility
Key inclusion criteria
* 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
Minimum age
0 Days
Maximum age
90 Days
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/08/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/01/2021
Sample size
Target
Accrual to date
Final
44
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Royal Hospital for Women - Sydney
Recruitment hospital [2] 0 0
Children's Hospital at Westmead - Sydney
Recruitment hospital [3] 0 0
Royal Children's Hospital Melbourne - Melbourne
Recruitment hospital [4] 0 0
Monash Children's Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2031 - Sydney
Recruitment postcode(s) [2] 0 0
- Sydney
Recruitment postcode(s) [3] 0 0
3052 - Melbourne
Recruitment postcode(s) [4] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Murdoch Childrens Research Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Royal Children's Hospital
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Royal Hospital For Women
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
University of Otago
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Sydney Children's Hospitals Network
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Monash Health
Address [5] 0 0
Country [5] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Amanda Wilkins, MBBS
Address 0 0
Murdoch Children's Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04044703