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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05770622




Registration number
NCT05770622
Ethics application status
Date submitted
5/03/2023
Date registered
15/03/2023
Date last updated
14/11/2024

Titles & IDs
Public title
Improving Therapeutic Drug Monitoring and Dosing for Vancomycin in Young Infants With Infections (VANCAPP) (Part 2)
Scientific title
The VANcomycin Cohort Study - Assessing Precise Dosing and Prompt Drug Monitoring to Improve Attainment of Target Concentrations (Part 2)
Secondary ID [1] 0 0
HREC2019.059 (part 2)
Universal Trial Number (UTN)
Trial acronym
VANCAPP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sepsis 0 0
Infections 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
Other interventions - First-dose trough dose adjustment calculator - using early TDM (first-dose trough) to determine an early dose adjustment if the predicted steady-state trough is outside of target range (10-20mg/L)

Experimental: Vancomycin first-dose trough dose adjustment calculation - Participants will have individualised model-based intermittent vancomycin dosing using the Vanc App dosing calculator (as used in VANC APP Part 1, see clinicaltrials.gov ID: NCT04044703). A first-dose trough concentration will be measured for each participant and the clinician will then enter that concentration into the web application ('First-dose trough dose adjustment calculator'). A dose adjustment will be generated by the calculator if the predicted steady-state level is outside of target range. If the predicted steady-state level is within target range (10-20mg/L) the calculator will recommend continuing with the same dose. The vancomycin concentration is then measured at steady state to determine if the target concentration has been achieved.


Other interventions: First-dose trough dose adjustment calculator - using early TDM (first-dose trough) to determine an early dose adjustment if the predicted steady-state trough is outside of target range (10-20mg/L)
CALCULATOR: A 'First-dose trough dose adjustment calculator' was developed based on a population pharmacokinetic model. A participant's post-menstrual age, weight, creatinine, target trough concentration, dose, dosing interval and first-dose trough concentration (taken immediately before the second dose is due) are entered into the calculator. The calculator determines if a dose adjustment is required (based on whether the predicted steady-state trough concentration is \<10mg/L or \>20mg/L) and, if required, recommends a new adjusted dose.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Target concentration at first steady-state concentration
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
Sub- and supratherapeutic concentrations at first steady-state concentration
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
Drug-related adverse effects
Timepoint [2] 0 0
From first vancomycin dose (immediately after consent) 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)
Minimum age
0 Days
Maximum age
90 Days
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Infants with a 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/11/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Royal Children's Hospital Melbourne - Melbourne
Recruitment hospital [2] 0 0
Monash Newborn - Melbourne
Recruitment hospital [3] 0 0
Royal Hospital for Women - Sydney
Recruitment hospital [4] 0 0
The Children's Hospital at Westmead - Sydney
Recruitment postcode(s) [1] 0 0
3052 - Melbourne
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment postcode(s) [3] 0 0
- Sydney

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
Sydney Children's Hospitals Network
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Monash Health
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
A challenge to intermittent vancomycin dosing in young infants is the avoidable delay caused by the need to wait until steady state (i.e. when the drug concentrations are in equilibrium) to measure a vancomycin concentration, as this generally occurs 24 to 48 hours after starting treatment. If the target concentration is not achieved, the dose needs to be adjusted, resulting in further delays in an infant achieving the concentration required to treat their infection. The purpose of this study is to assess the use of early therapeutic drug monitoring (first-dose trough) and, if needed, early dose adjustment, in achieving target vancomycin concentrations at steady state. A dose adjustment calculator (available through a web application) will be used to determine the need for dose adjustment (based on predicted steady state concentration) and recommend an adjusted dose if required.
Trial website
https://clinicaltrials.gov/study/NCT05770622
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Amanda Wilkins, MBBS
Address 0 0
Royal Children's Hospital Melbourne, 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
Amanda Wilkins, MBBS
Address 0 0
Country 0 0
Phone 0 0
9345 5522
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05770622