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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02962934




Registration number
NCT02962934
Ethics application status
Date submitted
1/11/2016
Date registered
15/11/2016

Titles & IDs
Public title
An Observational Pharmacokinetic Sudy of Ceftolozane-Tazobactam in Intensive Care Unit in Patients With and Without CRRT
Scientific title
An Observational Pharmacokinetic Sudy of Ceftolozane-Tazobactam in Intensive Care Unit in Patients With and Without Continuous Renal Replacement Therapy.
Secondary ID [1] 0 0
Royal_Brisbane
Universal Trial Number (UTN)
Trial acronym
CT-PK
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gram-Negative Bacterial Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Non CRRT group
Other interventions - CRRT group

Non CRRT group - Critically ill patients receiving Ceftolozane-Tazobactam not receiving continuous renal replacement therapy

CRRT group - Critically ill patients receiving Ceftolozane-Tazobactam who require continuous renal replacement therapy


Other interventions: Non CRRT group
Non CRRT group:Blood samples prior to first dose of Ceftolozane-Tazobactam and at 15, 45, 1hr, 2hr 3hr 4h 5h 6h 7h 8h.

Other interventions: CRRT group
CRRT group: Pre and Post dialysis filter blood samples taken prior to first dose of Ceftolozane-tazobactam and at 15min, 45min, 1h 2h 3h 4h 5h 6h 7h 8h.

Ultrafiltrate samples at 1 hr,2h 4h 6h 8h
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Probability of Target Attainment for 40% fT>MIC
Timepoint [1] 0 0
24 hour period

Eligibility
Key inclusion criteria
Group 1 Non CRRT

* Diagnosis of systemic infection known or suspected to be caused by an organism susceptible to ceftolozane-tazobactam
* Age more than 18 years
* The treating clinician considers Ceftolozane-tazobactam to be an appropriate agent to treat the infection Group 2 CRRT
* Diagnosis of systemic infection known or suspected to be caused by an organism susceptible to ceftolozane-tazobactam
* Age more than18 years
* Prescribed to receive CRRT
* The treating clinician considers Ceftolozane-tazobactam to be an appropriate agent to treat the infection
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Group 1 Non CRRT

* Renal dysfunction that necessitates the use of renal replacement therapy
* Known or suspected allergy to cephalosporins
* Receipt of any Pipercillin-Tazobactam for the treatment of this current infection.
* Pregnancy Group 2 CRRT
* Known or suspected allergy to cephalosporins
* Pregnancy
* Receipt of any Pipercillin-Tazobactam for the treatment of this current infection

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/11/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2019
Sample size
Target
Accrual to date
Final
18
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, Professor
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
All data will be reported and analysed in a de-identified format.


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/NCT02962934