A Multicenter Randomized Controlled Study on Pharmacokinetic-Guided Vancomycin Use in Children With Severe Infections

Abstract

This study is a multicenter, randomized controlled prospective trial aimed at evaluating the effects of two vancomycin pharmacokinetics/pharmacodynamics (PK/PD) parameters on clinical outcomes in children with different severe infections: trough concentration (C_min) and the area under the curve (AUC_0-24/MIC). From January 2023 to December 2024, 472 pediatric patients from seven hospitals in Southwest China were included in the present study. These patients were randomly assigned to the AUC_0-24/MIC group or the C_min group. After excluding 75 patients with renal function impairment caused by the primary disease, three patients with incomplete data, and one patient who received vancomycin for less than 48 h, 393 patients were finally enrolled for the present study. Then, the vancomycin treatment for children was evaluated using two PK/PD parameters, to guide clinical efficacy and monitor the incidence of adverse reactions: AUC_0-24/MIC, with a target value of 400-600 mg·h/L; trough concentration (C_min), with a target value of 5-15 mg/L. The results indicated that there were no significant differences between the two groups in terms of daily dose, clinical efficacy, and adverse reactions. However, patients in the C_min group had significantly shorter pediatric intensive care unit (PICU) stays (Z = -2.05, p = 0.04), and patients in the 28-day to 1-year-old subgroup had shorter mechanical ventilation times (Z = -2.25, p = 0.024). Both C_min and AUC_0-24/MIC were effective in guiding the vancomycin treatment for children with severe infections. However, patients in the C_min group presented with advantages in PICU stay and ventilation duration. Trial Registration: China Clinical Trial Registry: ChiCTR2300067373.

Keywords: age groups; clinical efficacy; infections; pediatrics; pharmacokinetics; vancomycin.

FIGURE 1

Flowchart for the selection of patients.