NCT05770622 Improving Therapeutic Drug Monitoring and Dosing for Vancomycin in Young Infants With Infections (VANCAPP) (Part 2)
| NCT ID | NCT05770622 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Murdoch Childrens Research Institute |
| Condition | Sepsis |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-11-10 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 40 participants in total. It began in 2024-11-10 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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) 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
Contact & Investigator
Amanda Wilkins, MBBS
PRINCIPAL INVESTIGATOR
Royal Children's Hospital Melbourne, Murdoch Children's Research Institute
Frequently Asked Questions
Who can join the NCT05770622 clinical trial?
This trial is open to participants of all sexes, aged 0 Days or older, up to 90 Days, studying Sepsis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05770622 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05770622 currently recruiting?
Yes, NCT05770622 is actively recruiting participants. Contact the research team at amanda.wilkins@rch.org.au for enrollment information.
Where is the NCT05770622 trial being conducted?
This trial is being conducted at Melbourne, Australia, Melbourne, Australia, Sydney, Australia, Sydney, Australia.
Who is sponsoring the NCT05770622 clinical trial?
NCT05770622 is sponsored by Murdoch Childrens Research Institute. The principal investigator is Amanda Wilkins, MBBS at Royal Children's Hospital Melbourne, Murdoch Children's Research Institute. The trial plans to enroll 40 participants.