Status:
COMPLETED
Improving Dosing of Vancomycin in Young Infants With Infections
Lead Sponsor:
Murdoch Childrens Research Institute
Collaborating Sponsors:
Royal Children's Hospital
Royal Hospital For Women
Conditions:
Sepsis
Infection
Eligibility:
All Genders
Up to 90 years
Phase:
PHASE4
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 purpo...
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 h...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 3 2021
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT04044703
Start Date
August 30 2019
End Date
January 3 2021
Last Update
August 26 2021
Active Locations (4)
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1
Royal Hospital for Women
Sydney, New South Wales, Australia, 2031
2
Children's Hospital at Westmead
Sydney, New South Wales, Australia
3
Royal Children's Hospital Melbourne
Melbourne, Victoria, Australia, 3052
4
Monash Children's Hospital
Melbourne, Victoria, Australia