Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04821661




Registration number
NCT04821661
Ethics application status
Date submitted
17/03/2021
Date registered
29/03/2021
Date last updated
8/08/2023

Titles & IDs
Public title
T2 and SeptiCyte RAPID Duration Project
Scientific title
Duration of Bloodstream Infection as Measured by Conventional Cultures Compared With Novel Culture Independent Systems and Persistence of Biomarkers Associated With Severe Infection
Secondary ID [1] 0 0
HREC/2021/QRBW/70126
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bacteremia 0 0
Condition category
Condition code
Blood 0 0 0 0
Other blood disorders
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Duration of bloodstream infection measured by conventional blood cultures and the T2 magnetic resonance assay
Timepoint [1] 0 0
Days 1-4
Primary outcome [2] 0 0
Persistent infection defined as metastatic infection and lack of source control
Timepoint [2] 0 0
Days 1-4
Secondary outcome [1] 0 0
Short-term clinical outcome (SOFA success)
Timepoint [1] 0 0
Days 1-7
Secondary outcome [2] 0 0
Long-term clinical outcome
Timepoint [2] 0 0
6-months from the index BSI
Secondary outcome [3] 0 0
Persistent infection
Timepoint [3] 0 0
Day 1-4

Eligibility
Key inclusion criteria
* Patients who have proven bloodstream infection with any T2-on panel pathogen (Enterococcus faecium, S. aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, Escherichia coli and Candida spp.)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Palliative care approach
* Failure to give written informed consent (by patient or their legal representative)
* Polymicrobial index blood culture

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/01/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/08/2023
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Caboolture Hospital - Brisbane
Recruitment hospital [2] 0 0
Redcliffe Hospital - Brisbane
Recruitment hospital [3] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment postcode(s) [1] 0 0
- Brisbane

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Queensland
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Metro North Hospital and Health Service
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Pathology Queensland
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Infection with bacteria and other germs in the blood can be deadly. How long germs stay in the blood is important for two reasons. The first is that if they stay in the blood for many days it is a sign that antibiotics may need to be changed. The second is that if they stay in the blood for only a short time it may give doctors confidence to switch to tablets and consider early discharge from hospital. This study is evaluating the diagnostic and prognostic performance of two novel technologies when used to measure the duration of the bloodstream infection.
Trial website
https://clinicaltrials.gov/study/NCT04821661
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Tiffany Harris-Brown
Address 0 0
Country 0 0
Phone 0 0
+61 7 3346 6072
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04821661