The VANcomycin Cohort Study - Assessing Precise Dosing and Prompt Drug Monitoring to Improve Attainment of Target Concentrations (Part 2)

What this Trial Is About

Researchers are evaluating a new approach to dosing vancomycin in young infants with infections, sepsis, or bacteremia. The study aims to reduce delays in achieving effective drug levels by using early therapeutic drug monitoring (TDM) and dose adjustments based on the first dose, rather than waiting for steady state levels 24 to 48 hours after starting treatment. This Phase 4 study builds on previous work that developed a dosing calculator to predict steady-state vancomycin concentrations from early measurements. Participants receive individualized vancomycin dosing using a web-based dosing calculator called the Vanc App. After the first dose, a trough concentration is measured and entered into the calculator, which predicts whether the steady-state concentration will be within the target range of 10-20 mg/L. If the predicted level is outside this range, the calculator recommends an adjusted dose. A steady-state vancomycin concentration is then measured 24-48 hours after the first dose to confirm target attainment. During the study, infants are closely monitored with blood tests to measure vancomycin levels at specified times. Researchers assess whether early dose adjustments improve the proportion of infants reaching target drug concentrations at steady state. They also monitor for any drug-related side effects throughout treatment, typically lasting around five days. The total duration of participation varies but includes early dosing, steady-state monitoring, and follow-up during vancomycin therapy.

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