Dalbavancin Population Pharmacokinetic Modeling and Target Attainment Analysis

Clin Pharmacol Drug Dev. 2020 Jan;9(1):21-31. doi: 10.1002/cpdd.695. Epub 2019 May 14.


Dalbavancin is indicated for the treatment of acute bacterial skin and skin structure infections caused by susceptible gram-positive microorganisms. This analysis represents the update of the population pharmacokinetics (popPK) modeling and target attainment simulations performed with data from the single-dose safety and efficacy study and an unrelated but substantial revision of the preclinical pharmacokinetic/pharmacodynamic target (fAUC/MIC, free area under concentration-time curve/minimum inhibitory concentration ratio). A 3-compartment distribution model with first-order elimination provided an appropriate fit, with typical dalbavancin clearance of 0.05 L/h and total volume of distribution of ∼15 L. Impact of intrinsic factors was modest, although statistically significant (P < .05) relationships with total clearance were found for the following covariates: creatinine clearance, weight, and albumin - dose adjustment was only indicated for severe renal impairment. Under the new nonclinical target, simulations of the popPK model projected that >99% of subjects would achieve the nonclinical target at MIC values up to and including 2 mg/L.

Keywords: acute bacterial skin and skin structure infection; dalbavancin; long-acting intravenous antibiotic; pharmacokinetics; target attainment.

Publication types

  • Clinical Trial, Phase II
  • Clinical Trial, Phase III
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Anti-Bacterial Agents / pharmacokinetics*
  • Anti-Bacterial Agents / pharmacology
  • Area Under Curve
  • Bacteria / drug effects
  • Bacteria / growth & development
  • Female
  • Humans
  • Male
  • Microbial Sensitivity Tests
  • Middle Aged
  • Models, Biological*
  • Teicoplanin / analogs & derivatives*
  • Teicoplanin / pharmacokinetics
  • Teicoplanin / pharmacology
  • Young Adult


  • Anti-Bacterial Agents
  • Teicoplanin
  • dalbavancin