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Phase 2 N=10 Basic Science

Pharmacokinetics of Ceftolozane/Tazobactam in Plasma and Cerebrospinal Fluid

Pharmacokinetics

Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Unbound Ceftolozane Exposure in the Plasma — 322.6 mg*h/L

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Ceftolozane/tazobactam (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Royal Brisbane and Women's Hospital
Primary completion
May 2020

Outcome Measures

OutcomeResultp-value
PRIMARY
Unbound Ceftolozane Exposure in the Plasma
322.6
PRIMARY
Unbound Tazobactam Exposure in the Plasma
52.1
PRIMARY
Unbound Ceftolozane Exposure in the CSF
30.2
PRIMARY
Unbound Tazobactam Exposure in the CSF
5.6

Summary

Ceftolozane/tazobactam is an emerging newly available antibiotic that has a broad spectrum of activity, and could be potentially useful in the management of central nervous system infections. However, data relating to penetration of ceftolozane/ tazobactam into the central nervous system, where a barrier against drug distribution exists (i.e. blood brain barrier), is currently limited. In critically ill patients this is all the more challenging as achieving adequate antibiotic concentrations even in blood is difficult. The aim of this study is to describe the concentrations achieved in the cerebrospinal fluid (i.e. bodily fluid found surrounding and inside of the brain) and blood after a single dose of ceftolozane/tazobactam administered in critically ill patients with an existing external ventricular drain (i.e. a device used in neurosurgery that relieves elevated intracranial pressure in the brain). It is planned that this information gained will help develop dosing strategies that will achieve target concentrations that will successfully treat central nervous system infections in the future.

Eligibility Criteria

Inclusion Criteria

Patients with any infection requiring treatment with ceftolozane/tazobactam and who have met the following criteria:

  • Age >18 years
  • The presence of an indwelling external ventricular drain (EVD) or requiring EVD insertion due to obstructive hydrocephalus/subarachnoid haemorrhage

Exclusion Criteria

  • Known or suspected allergy to penicillins and cephalosporins
  • Pregnancy
  • Receiving renal replacement therapy
  • Glomerular filtration rate less than 10 mL/min
  • Receiving piperacillin/tazobactam or having received piperacillin/tazobactam in the past 7 days before enrolment
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03309657). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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