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

Study acronym: VANCAPP
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Mar 2026 to Dec 2026 Completion date: Jul 2026 to Apr 2027v11 Show 1 more changeShow less
    • Completion date: Jul 2026 to Apr 2027
  2. Primary completion date: Aug 2025 to Mar 2026 Completion date: Dec 2025 to Jul 2026v10 Show 1 more changeShow less
    • Completion date: Dec 2025 to Jul 2026
  3. Site details revised at 1 of 4 sitesv9
  4. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Nov 30, 2024 to Nov 10, 2024 · Site details revised at 4 of 4 sitesv8 Show 2 more changesShow less
    • Start date changed from estimate of Nov 30, 2024 to Nov 10, 2024
    • Site details revised at 4 of 4 sites
  5. Start date: Aug 2024 to Nov 30, 2024 Site contacts updated at 1 of 4 sitesv7 Show 1 more changeShow less
    • Site contacts updated at 1 of 4 sites
Show 5 earlier versionsHide 5 earlier versions
  1. Primary completion date: Dec 2024 to Aug 2025 Start date: Apr 2024 to Aug 2024 · Completion date: Mar 2025 to Dec 2025v6 Show 2 more changesShow less
    • Start date: Apr 2024 to Aug 2024
    • Completion date: Mar 2025 to Dec 2025
  2. Start date: Dec 2023 to Apr 2024v5
  3. Primary completion date: Mar 2024 to Dec 2024 Start date: Sep 2023 to Dec 2023 · Completion date: Dec 2024 to Mar 2025v4 Show 2 more changesShow less
    • Start date: Sep 2023 to Dec 2023
    • Completion date: Dec 2024 to Mar 2025
  4. Start date: Jun 2023 to Sep 2023v3
  5. Start date: Mar 2023 to Jun 2023v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05770622
Lead Sponsor Murdoch Childrens Research Institute
Collaborators: Royal Children's Hospital, Royal Hospital For Women, Sydney Children's Hospitals Network, Monash Health
Conditions Sepsis, Infections, Bacteremia
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov