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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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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
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Secondary ID [1]
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HREC/2021/QRBW/70126
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Bacteremia
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Condition category
Condition code
Blood
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Other blood disorders
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Infection
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Other infectious diseases
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Infection
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Studies of infection and infectious agents
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Duration of bloodstream infection measured by conventional blood cultures and the T2 magnetic resonance assay
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Assessment method [1]
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The T2 system is a new diagnostic detection method utilizing miniaturized magnetic resonance technology. The T2 system has been shown to quickly and accurately identify molecular targets within patient samples without the need for purification or extraction of target molecules from the sample. It does not require bacterial culture and can detect organisms as low as 1 CFU/mL in whole blood. The study will compare the duration of detectable pathogens in the bloodstream as measured by the T2 with the duration of bloodstream infection according to conventional cultures
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Timepoint [1]
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Days 1-4
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Primary outcome [2]
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Persistent infection defined as metastatic infection and lack of source control
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Assessment method [2]
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The study will explore the correlation between the duration of detectable pathogens in the bloodstream as measured by the T2 (duration of T2emia) and the presence of persistent infection
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Timepoint [2]
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Days 1-4
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Secondary outcome [1]
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Short-term clinical outcome (SOFA success)
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Assessment method [1]
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The study will explore the correlation between the duration of detectable pathogens in the bloodstream as measured by the T2 (duration of T2emia) and short-term clinical outcome. A "successful short-term outcome" or "SOFA success" is defined as survival for the first 7 days from BSI onset with a stable or decreased Sequential Organ Failure Assessment (SOFA) score (for ICU patients) or modified SOFA score (for non-ICU patients), defined as follows: if the baseline SOFA/mSOFA >=3, a decrease of at least 30% in that score, if the baseline SOFA/mSOFA <3, a stable or decreased SOFA/mSOFA score. Patients discharged before day 7 will be assumed to have improved SOFA scores. The lack of "SOFA success" will be defined "SOFA failure".
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Timepoint [1]
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Days 1-7
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Secondary outcome [2]
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Long-term clinical outcome
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Assessment method [2]
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The study will explore the correlation between the duration of detectable pathogens in the bloodstream as measured by the T2 (duration of T2emia) and long-term clinical outcomes. A "successful long-term outcome" is defined as survival for the first 6 months from the BSI onset and maintenance of the baseline functional performance status defined by the functional bloodstream infection score (FBIS) score 7 days prior to the BSI onset.
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Timepoint [2]
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6-months from the index BSI
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Secondary outcome [3]
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Persistent infection
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Assessment method [3]
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SeptiCyte is a host-response assay able to differentiate infectious from sterile inflammation by providing a score (SeptiScore) from 1-15. It is approved for the diagnosis of sepsis in ICU patients. Whether SeptiScore may have a role in diagnosing the persistence of the infection in patients with proven BSI is unknown. The study will explore the performance of SeptiScore in diagnosing persistent infection including persistent BSI and metastatic infection
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Timepoint [3]
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Day 1-4
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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.)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Palliative care approach
- Failure to give written informed consent (by patient or their legal representative)
- Polymicrobial index blood culture
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Study design
Purpose
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Duration
Cross-sectional
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
11/01/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/08/2023
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Caboolture Hospital - Brisbane
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Recruitment hospital [2]
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Redcliffe Hospital - Brisbane
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Recruitment hospital [3]
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Royal Brisbane and Women's Hospital - Brisbane
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Recruitment postcode(s) [1]
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- Brisbane
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Funding & Sponsors
Primary sponsor type
Other
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Name
The University of Queensland
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Metro North Hospital and Health Service
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Pathology Queensland
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04821661
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Tiffany Harris-Brown
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Address
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Country
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Phone
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+61 7 3346 6072
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04821661
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