Improving vancomycin dosing for young infants with infections
The VANcomycin Cohort Study - Assessing Precise Dosing and Prompt Drug Monitoring to Improve Attainment of Target Concentrations (Part 2)
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 |
| Enrollment | 40 (estimated) |
| Ages | 0 Days to 90 Days |
| Sex | All |
| Sponsor | Murdoch Childrens Research Institute Academic / other |
| Locations | 4 sites (Melbourne, Victoria and 3 other locations) |
| Trial ID | NCT05770622 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have shown promise in using early therapeutic drug monitoring for vancomycin, suggesting that this approach could be beneficial.
Eligibility criteria
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 this trial is running
Melbourne, Victoria and 3 other locations
- Royal Children's Hospital Melbourne — Melbourne, Victoria, Australia (Recruiting)
- Monash Newborn — Melbourne, Australia (Not_yet_recruiting)
- Royal Hospital for Women — Sydney, Australia (Not_yet_recruiting)
- The Children's Hospital at Westmead — Sydney, Australia (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.