Ceftolozane/Tazobactam Dose Selection for Pediatric Patients (Birth to <18 years)

Authors: Larson KB, Patel Y, Willavize S, Rizk ML, Yu B, Johnson MG, Rhee EG, Caro L
Conference: ACoP
Keywords: infectious disease, pharmacokinetic, PK, UTI, Zerbaxa
Division: Clinical Pharmacology and Pharmacometrics (CPP)

Abstract

  • Ceftolozane/tazobactam is a combination of the novel cephalosporin, ceftolozane, and the beta-lactamase inhibitor, tazobactam.
  • It is approved for the treatment of complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) in adults at the 1.5 g dose (1.0 g ceftolozane and 0.5 g tazobactam) administered as a 1-hr intravenous (IV) infusion every 8 hours [1].
  • A Phase 1 study (ClinicalTrials.gov ID, NCT02266706) was designed to assess the pharmacokinetics (PK) and safety of a single dose of ceftolozane/tazobactam in pediatric patients (ages birth [7 days post-natal] to < 18 years).
  • Sparse PK data collected in this study were used to develop ceftolozane and tazobactam population PK models for adult and pediatric subjects and to provide dosing recommendations for upcoming safety and efficacy pediatric clinical trials in cUTI and cIAI.

Eighth American Conference on Pharmacometrics (ACoP) Annual Meeting: October 15-18, 2017, Fort Lauderdale, FL

By Kajal B. Larson, Yogesh T. Patel, Susan Willavize, Matthew L. Rizk, Brian Yu, Matthew G. Johnson, Elizabeth G. Rhee and Luzelena Caro