Pharmacodynamics of an 800-mg dose of telithromycin in patients with community-acquired pneumonia caused by extracellular pathogens

Diagn Microbiol Infect Dis. 2005 May;52(1):45-52. doi: 10.1016/j.diagmicrobio.2004.12.005.

Abstract

The pharmacodynamics of telithromycin, a new ketolide antibacterial, was examined in 115 patients with community-acquired pneumonia (CAP). Patients received telithromycin 800 mg qd for 7-10 days. Pharmacokinetic parameters were determined, and exposure was linked to microbiological outcome using logistic regression analysis. A breakpoint for increased probability of microbiological eradication was developed and was found to be the ratio of area under the concentration-time curve (AUC) to minimum inhibitory concentration (MIC) of 3.375. The final logistic regression model of microbiological outcome included body weight and AUC/MIC ratio breakpoint. This model was found in analyses of the entire population and when Streptococcus pneumoniae and Haemophilus influenzae were examined separately. The AUC/MIC ratio target attainment rate is expected to be >99.9% for S. pneumoniae and Moraxella catarrhalis and 93.1% for H. influenzae. This study demonstrated a relationship between telithromycin drug exposure and microbiological outcome. Telithromycin is expected to achieve the drug exposure breakpoint for the majority of isolates causing CAP.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Anti-Bacterial Agents* / administration & dosage
  • Anti-Bacterial Agents* / pharmacokinetics
  • Anti-Bacterial Agents* / therapeutic use
  • Community-Acquired Infections / drug therapy*
  • Community-Acquired Infections / microbiology
  • Haemophilus influenzae / drug effects
  • Humans
  • Ketolides* / administration & dosage
  • Ketolides* / pharmacokinetics
  • Ketolides* / therapeutic use
  • Microbial Sensitivity Tests
  • Moraxella catarrhalis / drug effects
  • Pneumonia, Bacterial / drug therapy*
  • Pneumonia, Bacterial / microbiology
  • Streptococcus pneumoniae / drug effects
  • Treatment Outcome

Substances

  • Anti-Bacterial Agents
  • Ketolides
  • telithromycin