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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03309657




Registration number
NCT03309657
Ethics application status
Date submitted
30/07/2017
Date registered
13/10/2017

Titles & IDs
Public title
Pharmacokinetics of Ceftolozane/Tazobactam in Plasma and Cerebrospinal Fluid
Scientific title
A Prospective Pharmacokinetic Evaluation of the Plasma and Cerebrospinal Fluid Concentrations of a Single Dose Ceftolozane/Tazobactam in Infected Critically Ill Patients With an Indwelling External Ventricular Drain
Secondary ID [1] 0 0
HREC/17/QRBW/117
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pharmacokinetics 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ceftolozane/tazobactam

Experimental: Ceftolozane Tazobactam - Infected patients with external intraventricular drain will receive a single dose of Ceftolozane/ tazobactam (3000mg) over 1 hour and will undergo blood , csf and urine sampling at specific times over an 8 hour period.


Treatment: Drugs: Ceftolozane/tazobactam
This is an observational pharmacokinetic study whereby patients received a single dose of ceftolozane/tazobactam and plasma and cerebrospinal fluid samples were subsequently collected and analyzed to described the pharmacokinetics.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Unbound Ceftolozane Exposure in the Plasma
Timepoint [1] 0 0
Samples collected from 0 to 8 hours post dose at "0, 1, 2,4,6, & 8 h post dose were use estimate area under the curve from time zero to infinity estimated by non-compartmental analysis
Primary outcome [2] 0 0
Unbound Tazobactam Exposure in the Plasma
Timepoint [2] 0 0
Samples collected from 0 to 8 hours post dose at "0, 1, 2,4,6, & 8 h post dose were use estimate area under the curve from time zero to infinity estimated by non-compartmental analysis
Primary outcome [3] 0 0
Unbound Ceftolozane Exposure in the CSF
Timepoint [3] 0 0
Samples collected from 0 to 8 hours post dose at "0, 1, 2,4,6, & 8 h post dose were use estimate area under the curve from time zero to infinity estimated by non-compartmental analysis
Primary outcome [4] 0 0
Unbound Tazobactam Exposure in the CSF
Timepoint [4] 0 0
Samples collected from 0 to 8 hours post dose at "0, 1, 2,4,6, & 8 h post dose were use estimate area under the curve from time zero to infinity estimated by non-compartmental analysis

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Other
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2020
Sample size
Target
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment postcode(s) [1] 0 0
4029 - Brisbane

Funding & Sponsors
Primary sponsor type
Government body
Name
Royal Brisbane and Women's Hospital
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The University of Queensland
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jason A Roberts, PhD BPharm
Address 0 0
Royal Brisbane and Womens Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
There is no plan to make individual participant data available to other researchers


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03309657