Parameters influencing the pharmacokinetics/pharmacodynamics of piperacillin/tazobactam in patients with febrile neutropenia and haematological malignancy: a prospective study

J Antimicrob Chemother. 2019 Sep 1;74(9):2676-2680. doi: 10.1093/jac/dkz248.

Abstract

Objectives: To assess population pharmacokinetics (PK) and pharmacodynamics (PD) of both piperacillin and tazobactam in neutropenia patients and examine dosage requirements related to the MIC distribution for Gram-negative bacteria involved in bloodstream infections (BSIs).

Methods: We conducted a prospective study including adult haematological malignancy patients with febrile neutropenia receiving piperacillin/tazobactam as short (30 min) or prolonged (4 h) intravenous infusions. Concentration data were analysed using a population approach. Dosing simulations with the final model investigated factors influencing the PK/PD of piperacillin/tazobactam quantified by fT>MIC or PTA for piperacillin and tazobactam, respectively. In parallel, the local MIC distribution of β-lactams was documented for Gram-negative bacteria involved in BSIs.

Results: Over 10 months, 31 patients were enrolled, with 11 (35.5%) short and 20 (64.5%) prolonged infusion regimens. A one-compartment model adequately described the data for both drugs. Prolonged infusion, increased serum alkaline phosphatase (ALP) values and renal function impairment were associated with increased piperacillin fT>MIC. For patients with normal or augmented renal CL, dosing regimens q8h or q6h with 30 min of infusion were insufficient to achieve acceptable PTA for piperacillin/tazobactam at the median MIC value of 8 mg/L. Prolonged infusion of large doses was associated with the best PTA for both piperacillin and tazobactam.

Conclusions: In a population of haematological malignancy patients with neutropenia, renal function and ALP influenced the PK of piperacillin/tazobactam. Prolonged intravenous infusion would optimize the PK of piperacillin/tazobactam, especially in the case of augmented renal CL and/or low-range bacterial susceptibility.

MeSH terms

  • Adult
  • Aged
  • Anti-Bacterial Agents / administration & dosage
  • Anti-Bacterial Agents / pharmacokinetics*
  • Biomarkers
  • Dose-Response Relationship, Drug
  • Drug Monitoring
  • Febrile Neutropenia / diagnosis
  • Febrile Neutropenia / drug therapy*
  • Febrile Neutropenia / etiology*
  • Female
  • Hematologic Neoplasms / complications*
  • Hematologic Neoplasms / therapy
  • Humans
  • Infusions, Intravenous
  • Male
  • Microbial Sensitivity Tests
  • Middle Aged
  • Piperacillin, Tazobactam Drug Combination / administration & dosage
  • Piperacillin, Tazobactam Drug Combination / pharmacokinetics*
  • Treatment Outcome
  • Young Adult

Substances

  • Anti-Bacterial Agents
  • Biomarkers
  • Piperacillin, Tazobactam Drug Combination