Pharmacokinetics of Ceftolozane/Tazobactam in Plasma and Cerebrospinal Fluid

• Status: Completed
• Trial end date: 2020-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Royal Brisbane and Women's Hospital
• Collaborator: The University of Queensland
• Treatments: Ceftolozane; Ceftolozane, tazobactam drug combination; Cephalosporins; Penicillanic Acid; Tazobactam

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