Status:
ACTIVE_NOT_RECRUITING
Precision Dosing of Vancomycin in Critically Ill Children
Lead Sponsor:
University Hospital, Ghent
Collaborating Sponsors:
Belgium Health Care Knowledge Centre
University Ghent
Conditions:
Vancomycin
Eligibility:
All Genders
Up to 15 years
Phase:
PHASE4
Brief Summary
The overall objective of this project is to investigate the large-scale utility of MIPD of vancomycin at point-of-care in ICU children. This evaluation includes a comparison with the more standard app...
Detailed Description
Vancomycin is an antibiotic with a narrow therapeutic-toxic margin. This means that the minimum and maximum target blood target levels differ little from each other. Too low concentrations will reduce...
Eligibility Criteria
Inclusion
- age: 0-18 years
- admitted to ICU or PHO unit
- suspected or confirmed Gram positive infection
- planned to start on intravenous intermittent or continuous infusion vancomycin treatment
- informed consent signed by parents or legal representatives
- not previously enrolled in this trial
Exclusion
- extracorporeal treatment at inclusion or started during treatment (extracorporeal membrane oxygenation, dialysis, body cooling)
- n or p RIFLE category failure at inclusion (Day 0) (see section 8.1.2. screening)
- Known chronic kidney disease as defined by the KDIGO definition as: structural or functional abnormalities of the kidney regardless of GFR for \< 3 months or GFR \< 60ml/min/1.73m² for ≥ 3 months. eGFR is estimated using the modified Schwartz equation
- patient death is deemed imminent and inevitable
Key Trial Info
Start Date :
December 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2024
Estimated Enrollment :
314 Patients enrolled
Trial Details
Trial ID
NCT04666948
Start Date
December 28 2020
End Date
October 30 2024
Last Update
April 12 2024
Active Locations (7)
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1
AZ Sint-Jan Brugge-Oostende AV
Bruges, Belgium
2
Cliniques universitaires de Saint Luc
Brussels, Belgium
3
Erasme
Brussels, Belgium
4
Hopital universitaire de Reine Fabiola
Brussels, Belgium