Comparative pharmacodynamics of the new oxazolidinone tedizolid phosphate and linezolid in a neutropenic murine Staphylococcus aureus pneumonia model

Antimicrob Agents Chemother. 2012 Nov;56(11):5916-22. doi: 10.1128/AAC.01303-12. Epub 2012 Sep 10.

Abstract

Tedizolid phosphate (TR-701) is a novel oxazolidinone prodrug (converted to the active form tedizolid [TR-700]) with potent Staphylococcus aureus activity. The current studies characterized and compared the in vivo pharmacokinetic/pharmacodynamic (PD) characteristics of TR-701/TR-700 and linezolid against methicillin-susceptible S. aureus (MSSA) and methicillin-resistant S. aureus (MRSA) in the neutropenic murine pneumonia model. The pharmacokinetic properties of both drugs were linear over a dose range of 0.625 to 40 mg/kg of body weight. Protein binding was 30% for linezolid and 85% for TR-700. Mice were infected with one of 11 isolates of S. aureus, including MSSA and community- and hospital-acquired MRSA strains. Each drug was administered by oral-gastric gavage every 12 h (q12h). The dosing regimens ranged from 1.25 to 80 mg/kg/12 h for linezolid and 0.625 to 160 mg/kg/12 h for TR-701. At the start of therapy, mice had 6.24 ± 0.40 log(10) CFU/lungs, which increased to 7.92 ± 1.02 log(10) CFU/lungs in untreated animals over a 24-h period. A sigmoid maximum-effect (E(max)) model was used to determine the antimicrobial exposure associated with net stasis (static dose [SD]) and 1-log-unit reduction in organism relative to the burden at the start of therapy. The static dose pharmacodynamic targets for linezolid and TR-700 were nearly identical, at a free drug (non-protein-bound) area under the concentration-time curve over 24 h in the steady state divided by the MIC (AUC/MIC ratio) of 19 and 20, respectively. The 1-log-unit kill endpoints were also similar, at 46.1 for linezolid and 34.6 for TR-700. The exposure targets were also comparable for both MSSA and MRSA isolates. These dosing goals support further clinical trial examination of TR-701 in MSSA and MRSA pneumonia.

Publication types

  • Comparative Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acetamides / blood
  • Acetamides / pharmacokinetics*
  • Acetamides / pharmacology
  • Administration, Oral
  • Animals
  • Anti-Bacterial Agents / blood*
  • Anti-Bacterial Agents / pharmacokinetics*
  • Anti-Bacterial Agents / pharmacology
  • Area Under Curve
  • Blood Proteins / chemistry
  • Colony Count, Microbial
  • Disease Models, Animal
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Female
  • Linezolid
  • Lung / drug effects
  • Lung / microbiology
  • Methicillin-Resistant Staphylococcus aureus / drug effects
  • Methicillin-Resistant Staphylococcus aureus / growth & development
  • Mice
  • Mice, Inbred ICR
  • Microbial Sensitivity Tests
  • Neutropenia / blood*
  • Neutropenia / complications
  • Neutropenia / drug therapy
  • Neutropenia / microbiology
  • Organophosphates / blood*
  • Organophosphates / pharmacokinetics
  • Organophosphates / pharmacology
  • Oxazoles / blood*
  • Oxazoles / pharmacokinetics
  • Oxazoles / pharmacology
  • Oxazolidinones / blood
  • Oxazolidinones / pharmacokinetics*
  • Oxazolidinones / pharmacology
  • Pneumonia, Staphylococcal / blood*
  • Pneumonia, Staphylococcal / complications
  • Pneumonia, Staphylococcal / drug therapy
  • Pneumonia, Staphylococcal / microbiology
  • Prodrugs / metabolism
  • Prodrugs / pharmacokinetics*
  • Prodrugs / pharmacology
  • Protein Binding
  • Staphylococcus aureus / drug effects*
  • Staphylococcus aureus / growth & development

Substances

  • Acetamides
  • Anti-Bacterial Agents
  • Blood Proteins
  • Organophosphates
  • Oxazoles
  • Oxazolidinones
  • Prodrugs
  • Linezolid
  • tedizolid phosphate