Is the subcutaneous route an alternative for administering ertapenem to older patients? PHACINERTA study

J Antimicrob Chemother. 2019 Dec 1;74(12):3546-3554. doi: 10.1093/jac/dkz385.

Abstract

Background: Antibiotic administration by subcutaneous (SC) injection is common practice in French geriatric wards as an alternative to the intravenous (IV) route, but few pharmacokinetic/pharmacodynamic data are available. Ertapenem is useful for the treatment of infections with ESBL-producing enterobacteria.

Objectives: To report and compare ertapenem pharmacokinetic data between IV and SC routes in older persons.

Methods: Patients >65 years of age receiving ertapenem (1 g once daily) for at least 48 h (IV or SC, steady-state) were prospectively enrolled. Total ertapenem concentrations [residual (C0), IV peak (C0.5) and SC peak (C2.5)] were determined by UV HPLC. Individual-predicted AUC0-24 values were calculated and population pharmacokinetic analyses were performed. Using the final model, a Monte Carlo simulation involving 10 000 patients evaluated the influence of SC or IV administration on the PTA. Tolerance to ertapenem and recovery were also monitored. ClinicalTrials.gov identifier: NCT02505386.

Results: Ten (mean ± SD age=87±7 years) and 16 (age=88±5 years) patients were included in the IV and SC groups, respectively. The mean C0 and C2.5 values were not significantly different between the IV and SC groups (C0=12±5.9 versus 12±7.4 mg/L, P=0.97; C2.5=97±42 versus 67±41 mg/L, P=0.99). The mean C0.5 was higher in the IV group compared with the SC group (C0.5=184±90 versus 51±66 mg/L, P=0.001). The mean individual AUCs (1126.92±334.99 mg·h/L for IV versus 1005.3±266.0 mg·h/L for SC, P=0.38) and PTAs were not significantly different between groups. No severe antibiotic-related adverse effects were noted.

Conclusions: SC administration of ertapenem is an alternative to IV administration in older patients.

Publication types

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

MeSH terms

  • Administration, Intravenous / standards
  • Age Factors
  • Aged
  • Aged, 80 and over
  • Anti-Bacterial Agents / administration & dosage*
  • Anti-Bacterial Agents / pharmacokinetics*
  • Enterobacteriaceae Infections / drug therapy
  • Ertapenem / administration & dosage*
  • Ertapenem / pharmacokinetics*
  • Female
  • France
  • Geriatrics
  • Humans
  • Injections, Subcutaneous*
  • Male
  • Monte Carlo Method
  • Prospective Studies

Substances

  • Anti-Bacterial Agents
  • Ertapenem

Associated data

  • ClinicalTrials.gov/NCT02505386