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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
Date last updated
2/10/2019

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
The purpose of this study is to try to find out how critically ill patients receiving the antibiotic, ceftolozane-tazobactam, process it in their body. Investigators would like to study if the antibiotic concentrations during a dose of this antibiotic reaches the right concentrations necessary to kill the bacteria that is causing the infection. The process by which a drug travels through the body in blood, how it is broken down and removed by the body is called pharmacokinetics (PK). We can measure the PK by taking blood samples at specific times after the antibiotic is given.

Investigators would like to do the study in patients receiving dialysis and patients who are not receiving dialysis. This information about how the antibiotic is processed in the critically ill patient is unknown and it is important to know whether the doses doctors give patients to fight infection are adequate. If antibiotic concentrations are low in the blood, it gives the bacteria an opportunity to become resistant to the antibiotic which can lead to the antibiotic being less effective against bacteria potentially exposing future patients with infections to a limited range of effective antibiotics.

Patients will be consented, and given the antibiotic as prescribed. Blood samples will be taken from the drip that is already in the patients arm just as the antibiotic starts, at 15 and 45 minutes, at 1,2,3,4,5,6,7 and 8 hours. Patients who are on dialysis will have the blood samples taken from the dialysis machine before the blood reaches the dialysis filter (same blood samples as the non dialysis patients) and also bloods samples taken after the filter at 45 minutes, 2 and 6 hours. Dialysis patients will also have 5 separate samples of ultrafiltrate taken (approximately 10mls) - ultrafiltrate is the waste product of the dialysis process. The total amount of blood will be 40mls which is equal to about 2 tablespoons. The dialysis patient will have 50mls of blood taken.Information about the patients ICU stay will also be recorded.
Trial website
https://clinicaltrials.gov/study/NCT02962934
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02962934