Improving vancomycin dosing for young infants with infections
Official title: The VANcomycin Cohort Study - Assessing Precise Dosing and Prompt Drug Monitoring to Improve Attainment of Target Concentrations (Part 2)
Run by Murdoch Childrens Research Institute · NCT05770622 · Data updated 2026-11-12
This study is testing a new way to give the right amount of vancomycin to young infants with infections to help them get better faster.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 0 Days to 90 Days |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Murdoch Childrens Research Institute Academic / other |
| Locations | 4 sites (Melbourne, Victoria and 3 other locations) |
| Status | Recruiting |
| Started | November 10, 2024 |
| Main results expected | December 2026 |
| Study ends | April 2027 |
| Registry record updated | April 20, 2026 |
| Trial ID | NCT05770622 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are infants aged 0 to 90 days who have a suspected infection requiring vancomycin treatment for at least 48 hours.
✕Probably not a fit
Patients who may not benefit from this study include those with a corrected gestational age of less than 25 weeks or those with renal impairment.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to enhance the therapeutic drug monitoring (TDM) and dosing of vancomycin in young infants suffering from infections. By utilizing early TDM through a first-dose trough measurement, the study seeks to predict the steady-state concentration of the drug and allow for timely dose adjustments. This approach is designed to reduce the time it takes for infants to achieve effective antibiotic levels, thereby improving treatment outcomes for life-threatening infections. The study employs a web-based dose adjustment calculator to facilitate individualized dosing based on early drug concentration measurements.
Why it matters
Potential benefit: If successful, this study could significantly reduce the time to effective treatment for young infants with severe infections.
How similar studies have gone: Other studies have shown promise in using early therapeutic drug monitoring for vancomycin, suggesting that this approach could be beneficial.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Royal Children's Hospital Melbourne
Melbourne, Victoria, Australia Recruiting -
The Children's Hospital at Westmead
Sydney, Australia Recruiting -
Monash Newborn
Melbourne, Australia Not yet recruiting -
Royal Hospital for Women
Sydney, Australia Not yet recruiting
Study contacts
- Principal investigator: Amanda Wilkins, MBBS — Royal Children's Hospital Melbourne, Murdoch Children's Research Institute
- Study coordinator: Amanda Wilkins, MBBS
- Email: amanda.wilkins@rch.org.au
- Phone: 9345 5522
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.