Population Pharmacokinetics and Pharmacodynamics of Dalbavancin and C-Reactive Protein in Patients with Staphylococcal Osteoarticular Infections

Clin Pharmacokinet. 2024 Sep;63(9):1271-1282. doi: 10.1007/s40262-024-01410-2. Epub 2024 Aug 22.

Abstract

Background and objective: Dalbavancin is increasingly used for the long-term treatment of chronic osteoarticular infections. A population pharmacokinetic/pharmacodynamic (PK/PD) analysis for assessing the relationship between dalbavancin exposure and C-reactive protein (C-RP) over time was conducted.

Methods: Non-linear mixed-effect modeling was fitted to dalbavancin and C-RP concentrations. Monte Carlo simulations assessed the weekly percentage of C-RP reduction associated with different dosing regimens, starting from baseline to < 1 mg/dL.

Results: A total of 45 patients were retrospectively included in the analysis. The PK of dalbavancin was described by a two-compartment model, and the PD of C-RP was described by an indirect turnover maximum inhibition model. The total dalbavancin concentration model estimate producing 50% of maximum C-RP production inhibition (IC50) was 0.70 mg/L. Monte Carlo simulations showed that in patients with staphylococcal osteoarticular infections targeting total dalbavancin concentrations at > 14.5 mg/L at any time point may achieve C-RP production inhibition over time in > 95% of patients. Based on this, the findings showed that a cumulative dose of 3000 mg administered in the first 3 weeks may lead to a > 90% C-RP decrease versus baseline in approximately 5-6 weeks. In patients needing treatment prolongation, an additional 1500 mg dose after this period may maintain C-RP concentrations < 1 mg/dL for other 3 weeks.

Conclusions: A decrease in C-RP is related to dalbavancin exposure in osteoarticular infections. Targeting dalbavancin plasma concentrations above the efficacy threshold may be associated with effective treatment.

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Anti-Bacterial Agents* / administration & dosage
  • Anti-Bacterial Agents* / blood
  • Anti-Bacterial Agents* / pharmacokinetics
  • Anti-Bacterial Agents* / pharmacology
  • Anti-Bacterial Agents* / therapeutic use
  • C-Reactive Protein* / analysis
  • C-Reactive Protein* / metabolism
  • Female
  • Humans
  • Male
  • Middle Aged
  • Models, Biological
  • Monte Carlo Method
  • Retrospective Studies
  • Staphylococcal Infections* / drug therapy
  • Staphylococcal Infections* / microbiology
  • Teicoplanin* / administration & dosage
  • Teicoplanin* / analogs & derivatives
  • Teicoplanin* / blood
  • Teicoplanin* / pharmacokinetics
  • Teicoplanin* / pharmacology

Substances

  • Anti-Bacterial Agents
  • C-Reactive Protein
  • dalbavancin
  • Teicoplanin