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Search / Trial NCT05770622

Improving Therapeutic Drug Monitoring and Dosing for Vancomycin in Young Infants With Infections (VANCAPP) (Part 2)

Launched by MURDOCH CHILDRENS RESEARCH INSTITUTE · Mar 5, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

The VANCAPP trial is studying a way to improve how we monitor and adjust the dosage of a medication called vancomycin, which is used to treat serious infections in young infants. One challenge with vancomycin is that it can take 24 to 48 hours before doctors know if the initial dose was effective. During this waiting period, infants may not receive the optimal dose needed to fight their infection. This study aims to see if checking the drug levels earlier, right after the first dose, and adjusting the dose quickly if necessary, can help ensure that infants reach the right levels of the medicine sooner.

To participate in this study, infants must be between 0 and 90 days old and suspected of having an infection that needs treatment with vancomycin for at least two days. However, some infants may not be eligible, including those born very prematurely or those with certain medical conditions. If eligible, participants can expect to receive vancomycin as part of their treatment, and their doctors will use a special calculator to help determine if their dose needs to be adjusted based on early drug level checks. This trial is currently looking for participants, and it could lead to better treatment outcomes for infants with serious infections.

Gender

ALL

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

About Murdoch Childrens Research Institute

Murdoch Children's Research Institute (MCRI) is a leading pediatric research organization based in Australia, dedicated to improving child health through innovative research and clinical trials. With a focus on understanding and addressing the unique health challenges faced by children, MCRI collaborates with hospitals, universities, and community partners to translate research findings into practical solutions. The institute's multidisciplinary team of scientists, clinicians, and researchers is committed to advancing pediatric medicine and enhancing the quality of life for children and their families through groundbreaking studies and evidence-based interventions.

Locations

Sydney, , Australia

Melbourne, Victoria, Australia

Melbourne, , Australia

Sydney, , Australia

Patients applied

0 patients applied

Trial Officials

Amanda Wilkins, MBBS

Principal Investigator

Royal Children's Hospital Melbourne, Murdoch Children's Research Institute

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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