Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12624000332527
Ethics application status
Approved
Date submitted
1/03/2024
Date registered
26/03/2024
Date last updated
26/03/2024
Date data sharing statement initially provided
26/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigation of unusually rapid clearance of cefazolin
Scientific title
Investigation of hyper-excretion of cefazolin as a potential cause of treatment failure in patients with invasive bacterial infection
Secondary ID [1] 311646 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Abnormally rapid clearance of cefazolin 333101 0
Condition category
Condition code
Infection 329786 329786 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Administration of a single intravenous dose of 1g of cefazolin over 3-5 minutes
Intervention code [1] 328108 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337552 0
Area under the time-free plasma cefazolin concentration (AUC) curve after administration of a single 1g intravenous dose
Timepoint [1] 337552 0
Cefazolin free plasma concentration measurements will be done at 5 minutes, 10 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours and 8 hours after drug administration. The pharmacokinetic curve produced will be used to calculate the area under the time-free plasma cefazolin concentration curve.
Secondary outcome [1] 432309 0
Proportion of drug excreted unchanged in the urine
Timepoint [1] 432309 0
Over 8 hours from the time of drug administration
Secondary outcome [2] 432310 0
Free plasma cefazolin elimination half-life
Timepoint [2] 432310 0
Free plasma cefazolin concentration will be measured using a blood plasma laboratory assay at the following timepoints after cefazolin administration: 5 minutes, 10 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours. Half-life will be calculated from the pharmacokinetic curve produced.

Eligibility
Key inclusion criteria
Abnormally low plasma cefazolin concentration despite standard dosing and/or cefazolin treatment failure not easily explained by an alternative cause

Age greater than or equal to 18 years

Resolution of index infection

Provision of informed consent to participate in the study

Able to comply with study procedures
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Prior adverse reaction to cefazolin or any of its excipients

Poor venous access

Most recent haemoglobin concentration below 110g/L for women or 115g/L for men

Receipt of cefazolin within the last 7 days

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
Not Applicable
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/06/2024
Actual
Date of last participant enrolment
Anticipated
2/06/2025
Actual
Date of last data collection
Anticipated
2/06/2025
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 26181 0
New Zealand
State/province [1] 26181 0
Christchurch

Funding & Sponsors
Funding source category [1] 315974 0
University
Name [1] 315974 0
University of Otago
Country [1] 315974 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Country
New Zealand
Secondary sponsor category [1] 318115 0
None
Name [1] 318115 0
Address [1] 318115 0
Country [1] 318115 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314795 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 314795 0
https://ethics.health.govt.nz/about/southern-health-and-disability-ethics-committee/
Ethics committee country [1] 314795 0
New Zealand
Date submitted for ethics approval [1] 314795 0
21/12/2023
Approval date [1] 314795 0
26/01/2024
Ethics approval number [1] 314795 0
2023 EXP 17995

Summary
Brief summary
This study aims to determine whether patients treated with cefazolin who have incidentally been found to have very low plasma cefazolin concentrations in the course of standard clinical management of invasive bacterial infections have abnormally rapid clearance of this drug. After recovery, these opportunistically-identified patients will be administered a 1g dose of cefazolin and will then have multiple free plasma concentration measurements in the 8 hours post-dose. These data will be used to construct pharmacokinetic curves which will then be compared with known drug pharmacokinetics in normal individuals. Patients will be asked to provide written informed consent prior to enrolment in the study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132758 0
Dr Nicholas Douglas
Address 132758 0
Department of Medicine, University of Otago, PO Box 4345, Christchurch 8140
Country 132758 0
New Zealand
Phone 132758 0
+64 33640640
Fax 132758 0
Email 132758 0
Nick.Douglas@otago.ac.nz
Contact person for public queries
Name 132759 0
Nicholas Douglas
Address 132759 0
Department of Medicine, University of Otago, PO Box 4345, Christchurch 8140
Country 132759 0
New Zealand
Phone 132759 0
+64 33640640
Fax 132759 0
Email 132759 0
Nick.Douglas@otago.ac.nz
Contact person for scientific queries
Name 132760 0
Nicholas Douglas
Address 132760 0
Department of Medicine, University of Otago, PO Box 4345, Christchurch 8140
Country 132760 0
New Zealand
Phone 132760 0
+64 33640640
Fax 132760 0
Email 132760 0
Nick.Douglas@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.